Risk Factors for Adverse Reactions to Nurse-Administered Propofol During Outpatient Endoscopy: A Cross-Sectional Study

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Propofol is a common choice for outpatient sedation due to its rapid onset and predictable recovery time. Although propofol has an established safety profile, adverse drug reactions (ADRs) can still occur. This study investigated the prevalence and risk factors associated with ADRs related to nurse-administered propofol sedation during outpatient endoscopic procedures at a private hospital in Peru. Method We conducted a retrospective study. The clinical records of 919 Peruvian patients who underwent endoscopic interventions under propofol sedation were reviewed. This study included patients between the ages of 18 and 69 years who had American Society of Anesthesiologists (ASA) physical status classification scores of I–III and who were hemodynamically stable with an oxygen saturation (SO2) > 90% before the procedure. Sedation was nurse-administered using standardized protocols. ADR data, including severity and causality assessment data, were collected. Data were collected and analyzed by SPSS, Inc., and the statistical significance was calculated at the p < 0.05 level. Results A total of 693 patients were included in the study, 30.9% of whom experienced at least one ADR, predominantly cardiovascular or respiratory events such as hypotension and hypoxia, with causality scores classified as probable or definitive. Among the ADRs, 35.8% (n = 87) were moderately severe, and 64.2% (n = 143) were mildly severe. There were no reports of any serious adverse events. An ASA class III status (p = 0.048, PR adjusted (PRa) = 1.73, 95% CI: 1.01–2.99) and a procedure time of more than 20 minutes (p < 0.0001, PRa = 2.05, and 95% CI: 1.53–2.73) were significant risk factors for ADR occurrence. Patients with ADRs had longer recovery times than did those without ADRs (22 min ± 22.5 vs 14 min ± 8, respectively; p < 0.001). Conclusion In our work, moderate propofol sedation administered by trained nursing staff to outpatients undergoing interventional endoscopic procedures was generally safe but not free from risks. Vital parameters should be monitored regularly during long-term interventions and when patients are classified as ASA III. propofol adverse drug reactions endoscopic procedures nurse Peru Figures Figure 1 Figure 2 Figure 3 INTRODUCTION Gastrointestinal endoscopy is a routine procedure employed for both diagnostic and therapeutic purposes. It involves the insertion of a flexible tube equipped with a camera and light source into the gastrointestinal tract, aiming to visualize and assess the lining of the esophagus, stomach, and intestines. To ensure patient comfort and cooperation throughout this process, sedation is frequently administered 1 . Propofol, a short-acting intravenous anesthetic agent, is increasingly utilized for sedation due to its rapid onset and predictable recovery profile in endoscopic procedures 2 . In outpatient settings, where rapid turnover and patient satisfaction are paramount, sedation with nurse-administered propofol has emerged as a convenient and cost-effective alternative to traditional anesthesia delivery models 3 . Sedation with propofol has several advantages; however, it is not free from risk and can potentially lead to adverse drug reactions (ADRs) affecting the central nervous, cardiovascular, and respiratory systems 4 – 6 . The severity of these events ranges from mild respiratory depression to life-threatening events such as hypotension and cardiovascular complications 7 . Sedative-related adverse events are a critical concern in this context. Despite the wide use of propofol sedation in outpatient endoscopy, there are fewer available publications concerning the profile safety of nurse-administered propofol sedation in comparison to propofol sedation administered by anesthesiologists, especially in nonclinical trial design studies or in populations from low-income countries 8 – 10 . Although some studies have shown that non-anaesthesiologists’ propofol sedation can be administered safely 9 , 10 and represents a significant reduction in the financial burden of personnel costs 11 , 12 , some developing countries can resist implementing this type of sedation due to the lack of evidence of the effectiveness and safety of this procedure in their specific populations. In countries with marked differences in access to the healthcare system, the implementation of this type of procedure might improve access to essential diagnostic and therapeutic services. By reducing costs, expanding access, and maintaining high standards of care through proper training and protocols, this approach could significantly benefit healthcare systems and patient populations in these regions. Therefore, we conducted a cross-sectional study to investigate the prevalence and identify the risk factors associated with ADRs related to moderate sedation with nurse-administered propofol during outpatient endoscopic procedures in a low-income country. METHODS Study design and population We conducted a single-center retrospective study in a private tertiary care hospital in Peru. We reviewed medical records from a database of 919 outpatients who received an endoscopic intervention performed under sedation with propofol from January 2021 to July 2022. Patients who were between 18 and 69 years old, who had American Society of Anesthesiologists (ASA) physical status classification scores of I–III, and who were hemodynamically stable with oxygen saturation (SO 2 ) > 90% before the procedure were included. Patients who received endoscopic procedures requiring deep sedation, who were pregnant, or who had a medical history of allergy to propofol were excluded. Procedures and sedation The procedures were performed at the Ambulatory Endoscopic Center. The endoscopic procedures were performed by experienced physicians (with advanced cardiovascular resuscitation certification), nurses, and researchers using standard techniques. In this study, sedation was carried out by a trained nurse. The physician was responsible for performing the procedure and ensuring the safety of the patient. Propofol was initially administered with a loading dose of 10 to 60 mg followed by a repeated bolus of 10 to 20 mg of this drug to maintain an adequate sedation level for the patient. Propofol was always administered intravenously. No other drugs for sedation were used. Continuous monitoring of heart rate, SO 2 , and respiratory rate was performed. Blood pressure was measured automatically before drug administration and then at 5-minute intervals. Vital signs and oxygenation were recorded at baseline, 5 minutes before the procedure, at the beginning, at the end of the procedure, and 5 minutes after the end of the procedure. Oxygen was not used routinely. If the SO 2 concentration fell below 90%, a chin-lift maneuver was performed. If the SO 2 concentration remained less than 90% for 30 seconds despite the maneuvers, supplemental oxygen was administered via a binasal cannula at 4 l/m. Variables and Data Collection In this study, ADRs were defined as any adverse response to a medication or medicinal product that is both “noxious and unintended” and that occurs at doses utilized in humans for preventive, diagnostic, or therapeutic purposes or for the alteration of physiological function. In addition, serious adverse events (SAEs) are considered any medical incident that, regardless of dosage, has the potential to lead to death, necessitate hospitalization or prolongation of hospitalization, cause persistent or significant disability/incapacity, or result in a congenital anomaly/birth defect 13 . Two independent researchers collected ADRs documented in the medical records from the beginning of the endoscopic intervention until patient recovery. In addition, a research pharmacist used the adapted Naranjo algorithm to establish causality between ADRs and propofol 14 , 15 . Only probable and definitive events were considered to determine severity, and other analyses were performed. The severity of ADRs was measured using Hartwig´s Severity Assessment Scale 16 . This scale categorizes the severity of ADRs into seven levels: levels 1 and 2 as mild (those that were self-limiting and able to resolve over time without treatment), levels 3 and 4 as moderate (those that required treatment or an increased length of stay by at least one day) and levels 5–7 as severe (those that were life-threatening or caused permanent harm or death). The frequencies of ADRs were classified as follows: very common ≥ 1/10 (≥ 10%), common ≥ 1/100 and < 1/10 (≥ 1 and < 10%), uncommon ≥ 1/1000 and < 1/100 (≥ 0.1 and < 1%), rare ≥ 1/10.000 and < 1/1.000 (≥ 0.01% and < 0.1%), very rare < 1/10.000 (< 0.01%) and unknown (described in package inserts as ADRs observed at the post commercialization stage but not during drug trials) 17 . Other variables were collected through a data collection sheet (DCS) designed with the Google Form tool. The DCS included basal characteristics (sex and age), unhealthy habits (alcohol use and smoking), and clinical profiles (ASA classification, Mallampati score 18 to evaluate the intubation difficulty, type of procedure, total dose used, procedure time, rescue measures and recovery time). The recovery time was defined as the time spent in the recovery area after procedural sedation until safe discharge (Aldrete score ≥ 10). Statistical analysis Quantitative variables are described as medians and interquartile ranges, and categorical variables are described as frequencies and percentages. We explored the association between the presence of ADRs and potential risk factors using the chi-square test. All variables were included in this analysis except for rescue maneuvers and recovery time. In addition, some variables (ASA classification, type of procedure, and Mallampati classification) were recategorized to maintain a proper number of patients in each cell for this statistical test. For the next step, variables with p < 0.20 (ASA classification, procedure time, and total dose) were included in the multivariable analysis with a robust Poisson regression model. We verified that excluding nonsignificant variables did not make an important contribution to the multivariate analysis in the presence of other variables according to the recommendations of Bursac et al 19 . The degree of association was represented by the prevalence ratio (PR) with its respective 95% confidence interval (95% CI). Furthermore, we compared the recovery time after endoscopic intervention between patients with or without ADRs to propofol using the Mann‒Whitney U test. Values of p < 0.05 were considered significant. Data analysis was performed using IBM SPSS Statistics for Windows (version 24.0, RRID: SCR_016479). Ethical considerations This research was approved by the Institutional Research Ethics Committee of San Juan Bautista Private University (Registry No. 1277–2022 - CIEI-UPSJB). RESULTS Sociodemographic characteristics of the patients According to the selection criteria, a total of 693 participants were included in this study. The patient selection process is described in Fig. 1 . The median age of the patients was 48 ± 18 years (range: 18–69 years). Additionally, 37.7% (n = 261) were males. The basal characteristics, unhealthy habits and clinical profiles of the patients are detailed in Table 1 . Table 1 Basal characteristics, unhealthy habits and clinical profiles of patients who received endoscopic intervention under sedation with propofol. Characteristics n % Basal characteristics Sex Female 432 62.3% Male 261 37.7% Age groups 18–35 131 18.9% 36–53 319 46.0% 54–69 243 35.0% Unhealthy habits Alcohol use Yes 28 4.1% No 665 95.9% Smoking Yes 20 2.9% No 673 97.1% Clinical profile ASA classification I 519 74.9% II 163 23.5% III 11 1.6% Type of procedure Endoscopy 160 23.0% Colonoscopy 198 28.6% Endoscopy + Colonoscopy 324 46.8% Echoendoscopy or Endoscopic ultrasound 7 1.0% ERCP 4 0.6% Total dose 170 ± 120* Mallampati Classification 1 211 30.5% 2 414 59.7% 3 66 9.5% 4 2 0.3% Procedure time ≤ 20 min 423 61.1% > 20 min 270 38.9% Rescue maneuvers Chin-lift maneuver 21 3.0% Supplemental oxygen administration 82 11.8% Recovery time 15 ± 21* *median ± interquartile range. ERCP: endoscopic retrograde cholangiopancreatography. Adverse drug reactions to propofol Of the total sample, 214 patients (30.9%) had at least one possible ADR. According to the causality score obtained via the Naranjo algorithm, all the events related to propofol administration were classified as probable or definitive. In total, 230 ADRs related to the cardiovascular or respiratory system were reported, including hypotension (systolic blood pressure < 90 mmHg), bradycardia (heart rate 100 beats/minute), tachypnea (breathing > 20 breaths/minute), and hypoxia (SO 2 < 90%). We did not find any SAEs in this study. The prevalence, frequency and severity of each ADR are explained in Fig. 2 . All frequencies were calculated based on the total population. Frequency of each ADR: a very common (≥ 10%), b common (≥ 1 and < 10%), and c uncommon (≥ 0.1 and < 1%). Legend. ADR: adverse drug reaction. Factors associated with adverse drug reactions related to propofol use We found that only two variables were significantly associated with the presence of ADRs related to propofol use. An ASA class III status (p = 0.048, PR adjusted (PRa) = 1.73, 95% CI: 1.01–2.99) and a procedure time of more than 20 minutes (p > 0.0001, PRa = 2.05, and 95% CI: 1.53–2.73) were risk factors for the occurrence of ADRs among patients who had received propofol. These analyses are described in detail in Table 2 . Table 2 Bivariate and logistic regression analyses of adverse drug reactions to propofol and other variables in patients who received endoscopic intervention under sedation with this drug. Propofol’s Adverse Drug Reaction No Yes n % n % p valor PRc 95% CI p valor PRa 95% CI Sex Male 183 70.1 78 29.9 Ref. Female 296 68.5 136 31.5 0.659 1.05 [0.83–1.32] Age groups 18–35 96 73.3 35 26.7 Ref. 36–53 222 69.6 97 30.4 0.362 1.26 [0.90–1.76] 54–69 161 66.3 82 33.7 1.13 [0.81–1.58] Alcohol use No 459 69 206 31 Ref. Yes 20 71.4 8 28.6 0.787 0.92 [0.50–1.67] Smoking No 463 68.8 210 31.2 Ref. Yes 16 80 4 20 0.324 0.64 [0.26–1.55] ASA Classification I y II 474 69.5 208 30.5 Ref. Ref. III 5 45.5 6 54.5 0.039 1.78 [1.03–3.10] 0.048 1.73 [1.01–2.99] Type of procedure Nonadvanced endoscopic procedure ✝ 472 69.2 210 30.8 Ref. Advanced endoscopic procedure ✝✝ 7 63.6 4 36.4 0.692 1.18 [0.53–2.60] Mallampati Classification 1 y 2 429 68.6 196 31.4 Ref. 3 y 4 50 73.5 18 26.5 0.421 0.84 [0.55–1.27] Procedure time ≤ 20 min 323 76.4 100 23.6 Ref. Ref. > 20 min 156 57.8 114 42.2 < 0.0001 1.78 [1.43–2.23] < 0.0001 2.05 [1.53–2.73] Total dose 160 ± 110* 190 ± 130* 0.012 1.01 [1.00-1.02] 0.146 0.99 [0.98-1.00] ✝Nonadvanced endoscopic procedures include endoscopy, colonoscopy and endoscopy + colonoscopy. ✝✝Advanced endoscopic procedures include echo-endoscopy or endoscopic ultrasound and endoscopic retrograde cholangiopancreatography (ERCP). *Median ± interquartile range. PRc: prevalence ratio crude. PRa: prevalence ratio adjusted. Ref.: reference. 95% CI: 95% confidence interval. Recovery time among patients with or without adverse drug reactions related to propofol use Finally, we found that patients with ADRs related to propofol use had longer recovery times than patients without these ADRs did (median ± interquartile range: 22 min ± 22.25 vs 14 min ± 19.0, respectively; p < 0.0001) (Fig. 3 ). Bars represent the median ± interquartile range of each group. ***p < 0.0001. DISCUSSION Propofol has been widely utilized for sedation during endoscopic procedures in the last decade. Its safety profile, when administered by properly trained health professionals, is comparable to or even superior to that of other frequently employed sedatives such as meperidine, fentanyl, and benzodiazepines such as midazolam 6 , 8 . We performed a retrospective study to assess the safety of propofol administered via boluses by nurses who were appropriately trained in the drug administration process and patient monitoring during endoscopic procedures. They play a critical role in maintaining the quality and safety of endoscopic procedures. There were few patients who required rescue maneuvers (including the chin-lift maneuver and supplemental oxygen administration), and there was no need for further respiratory assistance in any patient. Similar to other works 3 , 20 , in our study, nurse-administered propofol sedation was safe and practical for outpatient gastrointestinal endoscopy. In this study, we comprehensively documented every event that may be linked to an ADR, even if it was short-lived and appropriately resolved. We reported that 30.8% of the patients experienced at least one ADR during endoscopic intervention. The percentages of almost all the ADRs were consistent with the findings reported by Guzzo et al. 21 , except for hypoxia, which was lower in our study. This difference could be attributed to our use of a smaller total propofol dose and our decision not to employ additional drugs during the endoscopic procedures 22 . All the ADRs we found were of mild or moderate severity. We did not encounter any SAEs in our study. It is possible that the lack of SAEs may be imputed to our sample size. Duprey et al. 6 reported serious cardiovascular adverse events (SCAEs) of intravenous sedative drugs over an 8-year period. In the case of propofol (n = 1596), the percentages of patients with one or more SCAE events and the incidence of each SCAE event were 17% and 7 (10 6 days of sedative exposure), respectively. However, the authors included all reported events for propofol, not limited solely to endoscopic procedures. In another study, Wehrmann and Riphaus 23 showed that in a 6-year observation period of patients who received propofol sedation for interventional endoscopic procedures (n = 9547), assisted ventilation was required for 40 patients (0.4%), endotracheal intubation was necessary for 9 patients (0.09%), 28 patients required additional monitoring in the intensive care unit (ICU) (0.3%), and 3 patients likely died due to sedation-related side effects (mortality rate, 0.03%). Multivariate analyses revealed that an ASA class III was associated with the occurrence of ADRs in patients receiving propofol sedation. However, due to the small number of participants with this ASA classification in our study, this result should still be confirmed. Other studies have documented both significant 23 , 24 and nonsignificant 21 , 25 associations between these variables. These disparities could be explained by differences in the study design, procedure complexity, and type of sedation administered. A procedure time of more than 20 minutes was another independent risk factor in our study. Gemma et al. 24 reported an association between procedure duration and respiratory and cardiovascular adverse events in patients under propofol sedation during endoscopic interventions. This is possibly because prolonged procedures extend the exposure to the occurrence of ADRs in these patients. On the other hand, the overall recovery time in our study (15 min ± 21) was lower than that in other studies 21 , 26 . Although it is difficult to make a direct comparison among these results without a comprehensive understanding of the recovery criteria used in each study, the longer stays observed in the other studies may be related to the use of benzodiazepines 26 and higher propofol doses during the process of sedation 6 . In addition, we showed that patients who experienced ADRs had longer recovery times than patients who did not experience these events. This study has several limitations. First, the study primarily involved nonadvanced endoscopic procedures (endoscopy, colonoscopy, and endoscopy + colonoscopy), with the majority of patients having an ASA classification of I-II. Consequently, these findings were predominantly obtained within a low-risk context. Second, due to the unavailability of a suitable and accessible ADR data source in Peru 27 , as well as the Food and Drug Administration’s MedWatch Adverse Event Reporting System in the United States, we could not conduct a study with a large population. Third, this study could only show correlations and not establish causality among these variables. As strengths, this is the first study to evaluate the postmarketing safety profile of the use of propofol in endoscopic procedures in Peru, a low-income country, and it is one of the few such studies carried out in Latin America. This work highlights the importance of multidisciplinary collaboration among doctors, researchers, nurses, and pharmacists to investigate the safety profile of medications. Finally, although we included mainly a low-risk population, they constitute the majority of individuals receiving daily medical care in our country’s hospitals. CONCLUSION this study showed that interventional endoscopic procedures under moderate sedation with propofol administered by trained nursing staff were generally safe, yet there were some risks involved. There was an increased risk of adverse events associated with an ASA class III and a procedure duration greater than 20 minutes. ADRs were associated with longer recovery times than were those without ADRs. Additionally, it is important to highlight that the training of healthcare professionals in the use of propofol sedation is essential for ensuring the continued safety and well-being of patients undergoing interventional endoscopic procedures while also implementing proactive measures to mitigate these risks. Abbreviations ADR: Adverse Drug Reaction ASA: American Society of Anesthesiologists CI: Confidence Interval DCS: Data Collection Sheet ERCP: Endoscopic Retrograde Cholangiopancreatography PR: Prevalence Ratio PRc: Prevalence Ratio Crude PRa: Prevalence Ratio Adjusted Declarations Ethics approval and consent to participate This research was approved by the Institutional Research Ethics Committee of San Juan Bautista Private University (Registry No. 1277-2022 - CIEI-UPSJB). Because of retrospective study, informed consent was waived. Consent for publication Not applicable Availability of data and materials The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. Competing interests The authors declare that they have no competing interests Funding Not applicable. Authors' contributions JSC, AZ, and FS conceived and designed the study and drafted the manuscript. RI, JFS, and AZ analyzed and interpreted the study data. All authors acquired study data, revised the manuscript critically for important intellectual content, read and approved the final version of the manuscript, and agreed to its submission for publication. The corresponding author (JSC) and FS had full access to all the study data. All authors ensure the accuracy of the manuscript and agree to take personal responsibility for their contributions. Acknowledgements Not applicable. References Amornyotin S. Sedation-related complications in gastrointestinal endoscopy. 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Cite Share Download PDF Status: Published Journal Publication published 06 May, 2025 Read the published version in BMC Anesthesiology → Version 1 posted Editorial decision: Revision requested 16 Sep, 2024 Reviews received at journal 02 Sep, 2024 Reviewers agreed at journal 22 Aug, 2024 Reviews received at journal 18 Jul, 2024 Reviewers agreed at journal 08 Jul, 2024 Reviewers invited by journal 26 Jun, 2024 Editor invited by journal 24 Jun, 2024 Editor assigned by journal 19 Jun, 2024 Submission checks completed at journal 19 Jun, 2024 First submitted to journal 18 Jun, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4602195","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":326793601,"identity":"51825907-5a74-44a5-a9d0-e7b4ad226585","order_by":0,"name":"Renzo Inca","email":"","orcid":"","institution":"Universidad Privada San Juan Bautista","correspondingAuthor":false,"prefix":"","firstName":"Renzo","middleName":"","lastName":"Inca","suffix":""},{"id":326793602,"identity":"c7377c9a-201e-43ec-8ac6-77f862eed714","order_by":1,"name":"Cynthia Bazán Montero","email":"","orcid":"","institution":"Clínica Ricardo Palma","correspondingAuthor":false,"prefix":"","firstName":"Cynthia","middleName":"Bazán","lastName":"Montero","suffix":""},{"id":326793603,"identity":"05293056-5beb-4dab-9870-8d1b77329997","order_by":2,"name":"Estela Bulnes Montachez","email":"","orcid":"","institution":"Clínica Ricardo Palma","correspondingAuthor":false,"prefix":"","firstName":"Estela","middleName":"Bulnes","lastName":"Montachez","suffix":""},{"id":326793604,"identity":"f8a621d6-55e7-42f9-a44d-c46fbdf8995e","order_by":3,"name":"Lary Salazar Alva","email":"","orcid":"","institution":"Clínica Ricardo Palma","correspondingAuthor":false,"prefix":"","firstName":"Lary","middleName":"Salazar","lastName":"Alva","suffix":""},{"id":326793605,"identity":"f889f38a-a006-41ab-b589-88630da4fc4f","order_by":4,"name":"José Salvador Carrillo","email":"data:image/png;base64,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","orcid":"","institution":"Universidad Privada San Juan Bautista","correspondingAuthor":true,"prefix":"","firstName":"José","middleName":"Salvador","lastName":"Carrillo","suffix":""},{"id":326793606,"identity":"cc8064dc-19bc-4a10-add7-26caa15e8e9a","order_by":5,"name":"Alejandra Zevallos","email":"","orcid":"","institution":"Universidad Privada San Juan Bautista","correspondingAuthor":false,"prefix":"","firstName":"Alejandra","middleName":"","lastName":"Zevallos","suffix":""},{"id":326793607,"identity":"e836bc92-3bf1-45bc-8dd8-31f12631d45d","order_by":6,"name":"Fernando Salazar","email":"","orcid":"","institution":"Clínica Ricardo Palma","correspondingAuthor":false,"prefix":"","firstName":"Fernando","middleName":"","lastName":"Salazar","suffix":""}],"badges":[],"createdAt":"2024-06-18 22:53:55","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4602195/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4602195/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12871-025-03012-2","type":"published","date":"2025-05-06T15:57:04+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":60618691,"identity":"5af1213c-99f1-41bf-b193-2e2e2f12e0f8","added_by":"auto","created_at":"2024-07-18 20:38:54","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":164199,"visible":true,"origin":"","legend":"\u003cp\u003eThe selection process for patients who received endoscopic intervention under moderate sedation with propofol.\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-4602195/v1/3be3a3b76b363d91e06fabb3.jpeg"},{"id":60619801,"identity":"cd7b3bb7-7a1b-4609-836a-eeefe0c7cc33","added_by":"auto","created_at":"2024-07-18 20:46:54","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":213328,"visible":true,"origin":"","legend":"\u003cp\u003ePrevalence, frequency, and severity of adverse drug reactions reported in patients who received an endoscopic intervention performed under sedation with propofol.\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-4602195/v1/e5bdc96fa4ca27b4fc6ea08d.png"},{"id":60618689,"identity":"48e85b62-5b71-49a8-a7b5-456ba5646367","added_by":"auto","created_at":"2024-07-18 20:38:54","extension":"jpeg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":61223,"visible":true,"origin":"","legend":"\u003cp\u003eDifferences in recovery time after endoscopic intervention between patients with or without adverse drug reactions (ADRs) related to propofol use.\u003c/p\u003e","description":"","filename":"floatimage3.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-4602195/v1/d4c5fb5d8f812ce07f0822de.jpeg"},{"id":82537765,"identity":"7d416460-947c-4160-9f16-4e5515dd8e68","added_by":"auto","created_at":"2025-05-12 16:10:13","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1443954,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4602195/v1/91173922-cb49-49a1-93ae-bbd42d4cb5fc.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Risk Factors for Adverse Reactions to Nurse-Administered Propofol During Outpatient Endoscopy: A Cross-Sectional Study","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eGastrointestinal endoscopy is a routine procedure employed for both diagnostic and therapeutic purposes. It involves the insertion of a flexible tube equipped with a camera and light source into the gastrointestinal tract, aiming to visualize and assess the lining of the esophagus, stomach, and intestines. To ensure patient comfort and cooperation throughout this process, sedation is frequently administered\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003ePropofol, a short-acting intravenous anesthetic agent, is increasingly utilized for sedation due to its rapid onset and predictable recovery profile in endoscopic procedures\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e. In outpatient settings, where rapid turnover and patient satisfaction are paramount, sedation with nurse-administered propofol has emerged as a convenient and cost-effective alternative to traditional anesthesia delivery models\u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eSedation with propofol has several advantages; however, it is not free from risk and can potentially lead to adverse drug reactions (ADRs) affecting the central nervous, cardiovascular, and respiratory systems\u003csup\u003e\u003cspan additionalcitationids=\"CR5\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e. The severity of these events ranges from mild respiratory depression to life-threatening events such as hypotension and cardiovascular complications\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e. Sedative-related adverse events are a critical concern in this context.\u003c/p\u003e \u003cp\u003eDespite the wide use of propofol sedation in outpatient endoscopy, there are fewer available publications concerning the profile safety of nurse-administered propofol sedation in comparison to propofol sedation administered by anesthesiologists, especially in nonclinical trial design studies or in populations from low-income countries\u003csup\u003e\u003cspan additionalcitationids=\"CR9\" citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eAlthough some studies have shown that non-anaesthesiologists\u0026rsquo; propofol sedation can be administered safely\u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e,\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e and represents a significant reduction in the financial burden of personnel costs\u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e,\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e, some developing countries can resist implementing this type of sedation due to the lack of evidence of the effectiveness and safety of this procedure in their specific populations. In countries with marked differences in access to the healthcare system, the implementation of this type of procedure might improve access to essential diagnostic and therapeutic services. By reducing costs, expanding access, and maintaining high standards of care through proper training and protocols, this approach could significantly benefit healthcare systems and patient populations in these regions.\u003c/p\u003e \u003cp\u003eTherefore, we conducted a cross-sectional study to investigate the prevalence and identify the risk factors associated with ADRs related to moderate sedation with nurse-administered propofol during outpatient endoscopic procedures in a low-income country.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design and population\u003c/h2\u003e \u003cp\u003e We conducted a single-center retrospective study in a private tertiary care hospital in Peru. We reviewed medical records from a database of 919 outpatients who received an endoscopic intervention performed under sedation with propofol from January 2021 to July 2022. Patients who were between 18 and 69 years old, who had American Society of Anesthesiologists (ASA) physical status classification scores of I\u0026ndash;III, and who were hemodynamically stable with oxygen saturation (SO\u003csub\u003e2\u003c/sub\u003e)\u0026thinsp;\u0026gt;\u0026thinsp;90% before the procedure were included. Patients who received endoscopic procedures requiring deep sedation, who were pregnant, or who had a medical history of allergy to propofol were excluded.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eProcedures and sedation\u003c/h2\u003e \u003cp\u003eThe procedures were performed at the Ambulatory Endoscopic Center. The endoscopic procedures were performed by experienced physicians (with advanced cardiovascular resuscitation certification), nurses, and researchers using standard techniques. In this study, sedation was carried out by a trained nurse. The physician was responsible for performing the procedure and ensuring the safety of the patient.\u003c/p\u003e \u003cp\u003ePropofol was initially administered with a loading dose of 10 to 60 mg followed by a repeated bolus of 10 to 20 mg of this drug to maintain an adequate sedation level for the patient. Propofol was always administered intravenously. No other drugs for sedation were used.\u003c/p\u003e \u003cp\u003eContinuous monitoring of heart rate, SO\u003csub\u003e2\u003c/sub\u003e, and respiratory rate was performed. Blood pressure was measured automatically before drug administration and then at 5-minute intervals. Vital signs and oxygenation were recorded at baseline, 5 minutes before the procedure, at the beginning, at the end of the procedure, and 5 minutes after the end of the procedure.\u003c/p\u003e \u003cp\u003eOxygen was not used routinely. If the SO\u003csub\u003e2 concentration\u003c/sub\u003e fell below 90%, a chin-lift maneuver was performed. If the SO\u003csub\u003e2 concentration\u003c/sub\u003e remained less than 90% for 30 seconds despite the maneuvers, supplemental oxygen was administered via a binasal cannula at 4 l/m.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eVariables and Data Collection\u003c/h2\u003e \u003cp\u003eIn this study, ADRs were defined as any adverse response to a medication or medicinal product that is both \u0026ldquo;noxious and unintended\u0026rdquo; and that occurs at doses utilized in humans for preventive, diagnostic, or therapeutic purposes or for the alteration of physiological function. In addition, serious adverse events (SAEs) are considered any medical incident that, regardless of dosage, has the potential to lead to death, necessitate hospitalization or prolongation of hospitalization, cause persistent or significant disability/incapacity, or result in a congenital anomaly/birth defect\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eTwo independent researchers collected ADRs documented in the medical records from the beginning of the endoscopic intervention until patient recovery. In addition, a research pharmacist used the adapted Naranjo algorithm to establish causality between ADRs and propofol\u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e,\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u003c/sup\u003e. Only probable and definitive events were considered to determine severity, and other analyses were performed.\u003c/p\u003e \u003cp\u003eThe severity of ADRs was measured using Hartwig\u0026acute;s Severity Assessment Scale\u003csup\u003e\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u003c/sup\u003e. This scale categorizes the severity of ADRs into seven levels: levels 1 and 2 as mild (those that were self-limiting and able to resolve over time without treatment), levels 3 and 4 as moderate (those that required treatment or an increased length of stay by at least one day) and levels 5\u0026ndash;7 as severe (those that were life-threatening or caused permanent harm or death).\u003c/p\u003e \u003cp\u003eThe frequencies of ADRs were classified as follows: very common\u0026thinsp;\u0026ge;\u0026thinsp;1/10 (\u0026ge;\u0026thinsp;10%), common\u0026thinsp;\u0026ge;\u0026thinsp;1/100 and \u0026lt;\u0026thinsp;1/10 (\u0026ge;\u0026thinsp;1 and \u0026lt;\u0026thinsp;10%), uncommon\u0026thinsp;\u0026ge;\u0026thinsp;1/1000 and \u0026lt;\u0026thinsp;1/100 (\u0026ge;\u0026thinsp;0.1 and \u0026lt;\u0026thinsp;1%), rare\u0026thinsp;\u0026ge;\u0026thinsp;1/10.000 and \u0026lt;\u0026thinsp;1/1.000 (\u0026ge;\u0026thinsp;0.01% and \u0026lt;\u0026thinsp;0.1%), very rare\u0026thinsp;\u0026lt;\u0026thinsp;1/10.000 (\u0026lt;\u0026thinsp;0.01%) and unknown (described in package inserts as ADRs observed at the post commercialization stage but not during drug trials)\u003csup\u003e\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eOther variables were collected through a data collection sheet (DCS) designed with the Google Form tool. The DCS included basal characteristics (sex and age), unhealthy habits (alcohol use and smoking), and clinical profiles (ASA classification, Mallampati score\u003csup\u003e\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e to evaluate the intubation difficulty, type of procedure, total dose used, procedure time, rescue measures and recovery time). The recovery time was defined as the time spent in the recovery area after procedural sedation until safe discharge (Aldrete score\u0026thinsp;\u0026ge;\u0026thinsp;10).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eQuantitative variables are described as medians and interquartile ranges, and categorical variables are described as frequencies and percentages. We explored the association between the presence of ADRs and potential risk factors using the chi-square test. All variables were included in this analysis except for rescue maneuvers and recovery time. In addition, some variables (ASA classification, type of procedure, and Mallampati classification) were recategorized to maintain a proper number of patients in each cell for this statistical test. For the next step, variables with p\u0026thinsp;\u0026lt;\u0026thinsp;0.20 (ASA classification, procedure time, and total dose) were included in the multivariable analysis with a robust Poisson regression model. We verified that excluding nonsignificant variables did not make an important contribution to the multivariate analysis in the presence of other variables according to the recommendations of Bursac \u003cem\u003eet al\u003c/em\u003e\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e. The degree of association was represented by the prevalence ratio (PR) with its respective 95% confidence interval (95% CI). Furthermore, we compared the recovery time after endoscopic intervention between patients with or without ADRs to propofol using the Mann‒Whitney U test. Values of p\u0026thinsp;\u0026lt;\u0026thinsp;0.05 were considered significant. Data analysis was performed using IBM SPSS Statistics for Windows (version 24.0, RRID: SCR_016479).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eEthical considerations\u003c/h2\u003e \u003cp\u003e This research was approved by the Institutional Research Ethics Committee of San Juan Bautista Private University (Registry No. 1277\u0026ndash;2022 - CIEI-UPSJB).\u003c/p\u003e \u003c/div\u003e"},{"header":"RESULTS","content":"\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eSociodemographic characteristics of the patients\u003c/h2\u003e \u003cp\u003eAccording to the selection criteria, a total of 693 participants were included in this study. The patient selection process is described in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eThe median age of the patients was 48\u0026thinsp;\u0026plusmn;\u0026thinsp;18 years (range: 18\u0026ndash;69 years). Additionally, 37.7% (n\u0026thinsp;=\u0026thinsp;261) were males. The basal characteristics, unhealthy habits and clinical profiles of the patients are detailed in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBasal characteristics, unhealthy habits and clinical profiles of patients who received endoscopic intervention under sedation with propofol.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCharacteristics\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003en\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e%\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eBasal characteristics\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSex\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e432\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e62.3%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e261\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e37.7%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge groups\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e18\u0026ndash;35\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e131\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18.9%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e36\u0026ndash;53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e319\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e46.0%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e54\u0026ndash;69\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e243\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e35.0%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cem\u003eUnhealthy habits\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eAlcohol use\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4.1%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e665\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e95.9%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eSmoking\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.9%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e673\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e97.1%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cem\u003eClinical profile\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eASA classification\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e519\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e74.9%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eII\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e163\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23.5%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIII\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.6%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eType of procedure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEndoscopy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e160\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23.0%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eColonoscopy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e198\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e28.6%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEndoscopy\u0026thinsp;+\u0026thinsp;Colonoscopy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e324\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e46.8%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEchoendoscopy or Endoscopic ultrasound\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.0%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eERCP\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.6%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal dose\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e170\u0026thinsp;\u0026plusmn;\u0026thinsp;120*\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c3\" namest=\"c1\"\u003e \u003cp\u003eMallampati Classification\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e211\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e30.5%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e414\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e59.7%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e66\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9.5%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.3%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eProcedure time\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026le;\u0026thinsp;20 min\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e423\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e61.1%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;20 min\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e270\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e38.9%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c3\" namest=\"c1\"\u003e \u003cp\u003eRescue maneuvers\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChin-lift maneuver\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3.0%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSupplemental oxygen administration\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e82\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11.8%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRecovery time\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e15\u0026thinsp;\u0026plusmn;\u0026thinsp;21*\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e*median\u0026thinsp;\u0026plusmn;\u0026thinsp;interquartile range. ERCP: endoscopic retrograde cholangiopancreatography.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eAdverse drug reactions to propofol\u003c/h2\u003e \u003cp\u003eOf the total sample, 214 patients (30.9%) had at least one possible ADR. According to the causality score obtained via the Naranjo algorithm, all the events related to propofol administration were classified as probable or definitive.\u003c/p\u003e \u003cp\u003eIn total, 230 ADRs related to the cardiovascular or respiratory system were reported, including hypotension (systolic blood pressure\u0026thinsp;\u0026lt;\u0026thinsp;90 mmHg), bradycardia (heart rate\u0026thinsp;\u0026lt;\u0026thinsp;40 beats/minute), tachycardia (heart rate\u0026thinsp;\u0026gt;\u0026thinsp;100 beats/minute), tachypnea (breathing\u0026thinsp;\u0026gt;\u0026thinsp;20 breaths/minute), and hypoxia (SO\u003csub\u003e2\u003c/sub\u003e\u0026thinsp;\u0026lt;\u0026thinsp;90%). We did not find any SAEs in this study. The prevalence, frequency and severity of each ADR are explained in Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eAll frequencies were calculated based on the total population. Frequency of each ADR: \u003csup\u003ea\u003c/sup\u003every common (\u0026ge;\u0026thinsp;10%), \u003csup\u003eb\u003c/sup\u003ecommon (\u0026ge;\u0026thinsp;1 and \u0026lt;\u0026thinsp;10%), and \u003csup\u003ec\u003c/sup\u003euncommon (\u0026ge;\u0026thinsp;0.1 and \u0026lt;\u0026thinsp;1%). Legend. ADR: adverse drug reaction.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eFactors associated with adverse drug reactions related to propofol use\u003c/h2\u003e \u003cp\u003eWe found that only two variables were significantly associated with the presence of ADRs related to propofol use. An ASA class III status (p\u0026thinsp;=\u0026thinsp;0.048, PR adjusted (PRa)\u0026thinsp;=\u0026thinsp;1.73, 95% CI: 1.01\u0026ndash;2.99) and a procedure time of more than 20 minutes (p\u0026thinsp;\u0026gt;\u0026thinsp;0.0001, PRa\u0026thinsp;=\u0026thinsp;2.05, and 95% CI: 1.53\u0026ndash;2.73) were risk factors for the occurrence of ADRs among patients who had received propofol. These analyses are described in detail in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBivariate and logistic regression analyses of adverse drug reactions to propofol and other variables in patients who received endoscopic intervention under sedation with this drug.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"23\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c10\" colnum=\"10\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c11\" colnum=\"11\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c12\" colnum=\"12\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c13\" colnum=\"13\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c14\" colnum=\"14\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c15\" colnum=\"15\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c16\" colnum=\"16\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c17\" colnum=\"17\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c18\" colnum=\"18\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c19\" colnum=\"19\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c20\" colnum=\"20\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c21\" colnum=\"21\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c22\" colnum=\"22\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c23\" colnum=\"23\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c5\" namest=\"c2\"\u003e \u003cp\u003ePropofol\u0026rsquo;s Adverse Drug Reaction\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c12\" namest=\"c9\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"6\" nameend=\"c19\" namest=\"c14\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c23\" namest=\"c20\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c12\" namest=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"6\" nameend=\"c19\" namest=\"c14\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c23\" namest=\"c20\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003en\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003en\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003ep valor\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e \u003cp\u003ePRc\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c12\" namest=\"c9\"\u003e \u003cp\u003e95% CI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003ep valor\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"6\" nameend=\"c19\" namest=\"c14\"\u003e \u003cp\u003ePRa\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c23\" namest=\"c20\"\u003e \u003cp\u003e95% CI\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSex\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c12\" namest=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"6\" nameend=\"c19\" namest=\"c14\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c23\" namest=\"c20\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e183\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e70.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e78\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e29.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eRef.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c20\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c23\" namest=\"c21\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e296\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e68.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e136\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e31.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.659\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e1.05\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e \u003cp\u003e[0.83\u0026ndash;1.32]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c20\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c23\" namest=\"c21\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge groups\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c20\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c23\" namest=\"c21\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e18\u0026ndash;35\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e96\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e73.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e35\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e26.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eRef.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c20\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c23\" namest=\"c21\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e36\u0026ndash;53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e222\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e69.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e97\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e30.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.362\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e1.26\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e \u003cp\u003e[0.90\u0026ndash;1.76]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c20\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c23\" namest=\"c21\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e54\u0026ndash;69\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e161\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e66.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e82\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e33.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e1.13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e \u003cp\u003e[0.81\u0026ndash;1.58]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c20\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c23\" namest=\"c21\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAlcohol use\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c20\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c23\" namest=\"c21\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e459\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e69\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e206\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eRef.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c20\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c23\" namest=\"c21\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e71.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e28.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.787\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.92\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e \u003cp\u003e[0.50\u0026ndash;1.67]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c20\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c23\" namest=\"c21\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSmoking\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c20\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c23\" namest=\"c21\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e463\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e68.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e210\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e31.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eRef.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c20\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c23\" namest=\"c21\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e80\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.324\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.64\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e \u003cp\u003e[0.26\u0026ndash;1.55]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c20\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c23\" namest=\"c21\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eASA Classification\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c20\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c23\" namest=\"c21\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eI y II\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e474\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e69.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e208\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e30.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eRef.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e \u003cp\u003eRef.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c20\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c23\" namest=\"c21\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIII\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e45.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e54.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cb\u003e0.039\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e1.78\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c11\" namest=\"c8\"\u003e \u003cp\u003e\u003cb\u003e[1.03\u0026ndash;3.10]\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c16\" namest=\"c12\"\u003e \u003cp\u003e\u003cb\u003e0.048\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c17\"\u003e \u003cp\u003e\u003cb\u003e1.73\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c22\" namest=\"c18\"\u003e \u003cp\u003e\u003cb\u003e[1.01\u0026ndash;2.99]\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"1\" nameend=\"c23\" namest=\"c23\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eType of procedure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c20\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c23\" namest=\"c21\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNonadvanced endoscopic procedure\u003csup\u003e✝\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e472\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e69.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e210\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e30.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eRef.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c20\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c23\" namest=\"c21\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAdvanced endoscopic procedure\u003csup\u003e✝✝\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e63.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e36.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.692\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e1.18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e \u003cp\u003e[0.53\u0026ndash;2.60]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c20\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c23\" namest=\"c21\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMallampati Classification\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c20\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c23\" namest=\"c21\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1 y 2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e429\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e68.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e196\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e31.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eRef.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c20\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c23\" namest=\"c21\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e3 y 4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e73.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e26.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.421\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.84\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e \u003cp\u003e[0.55\u0026ndash;1.27]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c20\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c23\" namest=\"c21\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eProcedure time\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c20\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c23\" namest=\"c21\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026le;\u0026thinsp;20 min\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e323\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e76.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e23.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eRef.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e \u003cp\u003eRef.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c21\" namest=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c23\" namest=\"c22\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;20 min\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e156\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e57.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e114\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e42.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.0001\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e1.78\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e \u003cp\u003e\u003cb\u003e[1.43\u0026ndash;2.23]\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c14\" namest=\"c10\"\u003e \u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.0001\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c17\" namest=\"c15\"\u003e \u003cp\u003e\u003cb\u003e2.05\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c21\" namest=\"c18\"\u003e \u003cp\u003e\u003cb\u003e[1.53\u0026ndash;2.73]\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c23\" namest=\"c22\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal dose\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e160\u0026thinsp;\u0026plusmn;\u0026thinsp;110*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e190\u0026thinsp;\u0026plusmn;\u0026thinsp;130*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cb\u003e0.012\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e1.01\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c10\" namest=\"c8\"\u003e \u003cp\u003e\u003cb\u003e[1.00-1.02]\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c15\" namest=\"c11\"\u003e \u003cp\u003e0.146\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c18\" namest=\"c16\"\u003e \u003cp\u003e0.99\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c21\" namest=\"c19\"\u003e \u003cp\u003e[0.98-1.00]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c23\" namest=\"c22\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e✝Nonadvanced endoscopic procedures include endoscopy, colonoscopy and endoscopy\u0026thinsp;+\u0026thinsp;colonoscopy. ✝✝Advanced endoscopic procedures include echo-endoscopy or endoscopic ultrasound and endoscopic retrograde cholangiopancreatography (ERCP). *Median\u0026thinsp;\u0026plusmn;\u0026thinsp;interquartile range. PRc: prevalence ratio crude. PRa: prevalence ratio adjusted. Ref.: reference. 95% CI: 95% confidence interval.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eRecovery time among patients with or without adverse drug reactions related to propofol use\u003c/h2\u003e \u003cp\u003eFinally, we found that patients with ADRs related to propofol use had longer recovery times than patients without these ADRs did (median\u0026thinsp;\u0026plusmn;\u0026thinsp;interquartile range: 22 min\u0026thinsp;\u0026plusmn;\u0026thinsp;22.25 vs 14 min\u0026thinsp;\u0026plusmn;\u0026thinsp;19.0, respectively; p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001) (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eBars represent the median\u0026thinsp;\u0026plusmn;\u0026thinsp;interquartile range of each group. ***p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001.\u003c/p\u003e \u003c/div\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003ePropofol has been widely utilized for sedation during endoscopic procedures in the last decade. Its safety profile, when administered by properly trained health professionals, is comparable to or even superior to that of other frequently employed sedatives such as meperidine, fentanyl, and benzodiazepines such as midazolam\u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e,\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eWe performed a retrospective study to assess the safety of propofol administered via boluses by nurses who were appropriately trained in the drug administration process and patient monitoring during endoscopic procedures. They play a critical role in maintaining the quality and safety of endoscopic procedures. There were few patients who required rescue maneuvers (including the chin-lift maneuver and supplemental oxygen administration), and there was no need for further respiratory assistance in any patient. Similar to other works\u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e,\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e\u003c/sup\u003e, in our study, nurse-administered propofol sedation was safe and practical for outpatient gastrointestinal endoscopy.\u003c/p\u003e \u003cp\u003eIn this study, we comprehensively documented every event that may be linked to an ADR, even if it was short-lived and appropriately resolved. We reported that 30.8% of the patients experienced at least one ADR during endoscopic intervention. The percentages of almost all the ADRs were consistent with the findings reported by Guzzo et al.\u003csup\u003e\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u003c/sup\u003e, except for hypoxia, which was lower in our study. This difference could be attributed to our use of a smaller total propofol dose and our decision not to employ additional drugs during the endoscopic procedures\u003csup\u003e\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eAll the ADRs we found were of mild or moderate severity. We did not encounter any SAEs in our study. It is possible that the lack of SAEs may be imputed to our sample size. Duprey et al.\u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e reported serious cardiovascular adverse events (SCAEs) of intravenous sedative drugs over an 8-year period. In the case of propofol (n\u0026thinsp;=\u0026thinsp;1596), the percentages of patients with one or more SCAE events and the incidence of each SCAE event were 17% and 7 (10\u003csup\u003e6\u003c/sup\u003e days of sedative exposure), respectively. However, the authors included all reported events for propofol, not limited solely to endoscopic procedures. In another study, Wehrmann and Riphaus\u003csup\u003e\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e\u003c/sup\u003e showed that in a 6-year observation period of patients who received propofol sedation for interventional endoscopic procedures (n\u0026thinsp;=\u0026thinsp;9547), assisted ventilation was required for 40 patients (0.4%), endotracheal intubation was necessary for 9 patients (0.09%), 28 patients required additional monitoring in the intensive care unit (ICU) (0.3%), and 3 patients likely died due to sedation-related side effects (mortality rate, 0.03%).\u003c/p\u003e \u003cp\u003eMultivariate analyses revealed that an ASA class III was associated with the occurrence of ADRs in patients receiving propofol sedation. However, due to the small number of participants with this ASA classification in our study, this result should still be confirmed. Other studies have documented both significant\u003csup\u003e\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e,\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e\u003c/sup\u003e and nonsignificant\u003csup\u003e\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e,\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e\u003c/sup\u003e associations between these variables. These disparities could be explained by differences in the study design, procedure complexity, and type of sedation administered.\u003c/p\u003e \u003cp\u003eA procedure time of more than 20 minutes was another independent risk factor in our study. Gemma et al.\u003csup\u003e\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e\u003c/sup\u003e reported an association between procedure duration and respiratory and cardiovascular adverse events in patients under propofol sedation during endoscopic interventions. This is possibly because prolonged procedures extend the exposure to the occurrence of ADRs in these patients.\u003c/p\u003e \u003cp\u003eOn the other hand, the overall recovery time in our study (15 min\u0026thinsp;\u0026plusmn;\u0026thinsp;21) was lower than that in other studies\u003csup\u003e\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e,\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e\u003c/sup\u003e. Although it is difficult to make a direct comparison among these results without a comprehensive understanding of the recovery criteria used in each study, the longer stays observed in the other studies may be related to the use of benzodiazepines\u003csup\u003e\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e\u003c/sup\u003e and higher propofol doses during the process of sedation\u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e. In addition, we showed that patients who experienced ADRs had longer recovery times than patients who did not experience these events.\u003c/p\u003e \u003cp\u003eThis study has several limitations. First, the study primarily involved nonadvanced endoscopic procedures (endoscopy, colonoscopy, and endoscopy\u0026thinsp;+\u0026thinsp;colonoscopy), with the majority of patients having an ASA classification of I-II. Consequently, these findings were predominantly obtained within a low-risk context. Second, due to the unavailability of a suitable and accessible ADR data source in Peru\u003csup\u003e\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e\u003c/sup\u003e, as well as the Food and Drug Administration\u0026rsquo;s MedWatch Adverse Event Reporting System in the United States, we could not conduct a study with a large population. Third, this study could only show correlations and not establish causality among these variables. As strengths, this is the first study to evaluate the postmarketing safety profile of the use of propofol in endoscopic procedures in Peru, a low-income country, and it is one of the few such studies carried out in Latin America. This work highlights the importance of multidisciplinary collaboration among doctors, researchers, nurses, and pharmacists to investigate the safety profile of medications. Finally, although we included mainly a low-risk population, they constitute the majority of individuals receiving daily medical care in our country\u0026rsquo;s hospitals.\u003c/p\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003ethis study showed that interventional endoscopic procedures under moderate sedation with propofol administered by trained nursing staff were generally safe, yet there were some risks involved. There was an increased risk of adverse events associated with an ASA class III and a procedure duration greater than 20 minutes. ADRs were associated with longer recovery times than were those without ADRs. Additionally, it is important to highlight that the training of healthcare professionals in the use of propofol sedation is essential for ensuring the continued safety and well-being of patients undergoing interventional endoscopic procedures while also implementing proactive measures to mitigate these risks.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eADR: Adverse Drug Reaction\u003c/p\u003e\n\u003cp\u003eASA: American Society of Anesthesiologists\u003c/p\u003e\n\u003cp\u003eCI: Confidence Interval\u003c/p\u003e\n\u003cp\u003eDCS: Data Collection Sheet\u003c/p\u003e\n\u003cp\u003eERCP: Endoscopic Retrograde Cholangiopancreatography\u003c/p\u003e\n\u003cp\u003ePR: Prevalence Ratio\u003c/p\u003e\n\u003cp\u003ePRc: Prevalence Ratio Crude\u003c/p\u003e\n\u003cp\u003ePRa: Prevalence Ratio Adjusted\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis research was approved by the Institutional Research Ethics Committee of San Juan Bautista Private University (Registry No. 1277-2022 - CIEI-UPSJB). Because of retrospective study, informed consent was waived.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eJSC, AZ, and FS conceived and designed the study and drafted the manuscript. RI, JFS, and AZ analyzed and interpreted the study data. All authors acquired study data, revised the manuscript critically for important intellectual content, read and approved the final version of the manuscript, and agreed to its submission for publication. The corresponding author (JSC) and FS had full access to all the study data. All authors ensure the accuracy of the manuscript and agree to take personal responsibility for their contributions.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eAmornyotin S. Sedation-related complications in gastrointestinal endoscopy. 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Scand J Gastroenterol. 2008;43(3):368\u0026ndash;74. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1080/00365520701679181\u003c/span\u003e\u003cspan address=\"10.1080/00365520701679181\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGemma M, Pennoni F, Tritto R, Agostoni M. Risk of adverse events in gastrointestinal endoscopy: Zero-inflated Poisson regression mixture model for count data and multinomial logit model for the type of event. PLoS ONE. 2021;16(6 June):1\u0026ndash;16. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1371/journal.pone.0253515\u003c/span\u003e\u003cspan address=\"10.1371/journal.pone.0253515\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMedina-Prado L, Sempere JM, Bozhychko M, et al. 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Front Pharmacol. 2022;13:1047946. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.3389/fphar.2022.1047946\u003c/span\u003e\u003cspan address=\"10.3389/fphar.2022.1047946\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-anesthesiology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bane","sideBox":"Learn more about [BMC Anesthesiology](http://bmcanesthesiol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bane","title":"BMC Anesthesiology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"propofol, adverse drug reactions, endoscopic procedures, nurse, Peru","lastPublishedDoi":"10.21203/rs.3.rs-4602195/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4602195/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eEndoscopic procedures are essential for diagnosing and managing gastrointestinal conditions, often requiring sedation for patient comfort. Propofol is a common choice for outpatient sedation due to its rapid onset and predictable recovery time. Although propofol has an established safety profile, adverse drug reactions (ADRs) can still occur. This study investigated the prevalence and risk factors associated with ADRs related to nurse-administered propofol sedation during outpatient endoscopic procedures at a private hospital in Peru.\u003c/p\u003e\u003ch2\u003eMethod\u003c/h2\u003e \u003cp\u003eWe conducted a retrospective study. The clinical records of 919 Peruvian patients who underwent endoscopic interventions under propofol sedation were reviewed. This study included patients between the ages of 18 and 69 years who had American Society of Anesthesiologists (ASA) physical status classification scores of I\u0026ndash;III and who were hemodynamically stable with an oxygen saturation (SO2)\u0026thinsp;\u0026gt;\u0026thinsp;90% before the procedure. Sedation was nurse-administered using standardized protocols. ADR data, including severity and causality assessment data, were collected. Data were collected and analyzed by SPSS, Inc., and the statistical significance was calculated at the p\u0026thinsp;\u0026lt;\u0026thinsp;0.05 level.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eA total of 693 patients were included in the study, 30.9% of whom experienced at least one ADR, predominantly cardiovascular or respiratory events such as hypotension and hypoxia, with causality scores classified as probable or definitive. Among the ADRs, 35.8% (n\u0026thinsp;=\u0026thinsp;87) were moderately severe, and 64.2% (n\u0026thinsp;=\u0026thinsp;143) were mildly severe. There were no reports of any serious adverse events. An ASA class III status (p\u0026thinsp;=\u0026thinsp;0.048, PR adjusted (PRa)\u0026thinsp;=\u0026thinsp;1.73, 95% CI: 1.01\u0026ndash;2.99) and a procedure time of more than 20 minutes (p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001, PRa\u0026thinsp;=\u0026thinsp;2.05, and 95% CI: 1.53\u0026ndash;2.73) were significant risk factors for ADR occurrence. Patients with ADRs had longer recovery times than did those without ADRs (22 min\u0026thinsp;\u0026plusmn;\u0026thinsp;22.5 vs 14 min\u0026thinsp;\u0026plusmn;\u0026thinsp;8, respectively; p\u0026thinsp;\u0026lt;\u0026thinsp;0.001).\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eIn our work, moderate propofol sedation administered by trained nursing staff to outpatients undergoing interventional endoscopic procedures was generally safe but not free from risks. Vital parameters should be monitored regularly during long-term interventions and when patients are classified as ASA III.\u003c/p\u003e","manuscriptTitle":"Risk Factors for Adverse Reactions to Nurse-Administered Propofol During Outpatient Endoscopy: A Cross-Sectional Study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-07-18 20:38:49","doi":"10.21203/rs.3.rs-4602195/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-09-16T04:40:04+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-09-02T20:58:53+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"98953529644169963065041837870582065407","date":"2024-08-23T00:54:43+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-07-18T19:09:36+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"193385088423692564638485074531395318180","date":"2024-07-08T09:06:05+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-06-26T17:24:48+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2024-06-24T07:49:25+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-06-19T10:49:16+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-06-19T10:48:51+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Anesthesiology","date":"2024-06-18T22:52:47+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-anesthesiology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bane","sideBox":"Learn more about [BMC Anesthesiology](http://bmcanesthesiol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bane","title":"BMC Anesthesiology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"ab1ddcd5-96c0-4a69-864d-ee26c117aa9d","owner":[],"postedDate":"July 18th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-05-12T16:06:56+00:00","versionOfRecord":{"articleIdentity":"rs-4602195","link":"https://doi.org/10.1186/s12871-025-03012-2","journal":{"identity":"bmc-anesthesiology","isVorOnly":false,"title":"BMC Anesthesiology"},"publishedOn":"2025-05-06 15:57:04","publishedOnDateReadable":"May 6th, 2025"},"versionCreatedAt":"2024-07-18 20:38:49","video":"","vorDoi":"10.1186/s12871-025-03012-2","vorDoiUrl":"https://doi.org/10.1186/s12871-025-03012-2","workflowStages":[]},"version":"v1","identity":"rs-4602195","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4602195","identity":"rs-4602195","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}