Incidence of adverse events during emergency department procedural sedation by ASA Physical Status Classification: a multicenter prospective study

Incidence of adverse events during emergency department procedural sedation by ASA Physical Status Classification: a multicenter prospective study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Incidence of adverse events during emergency department procedural sedation by ASA Physical Status Classification: a multicenter prospective study minoru hayashi, kentaro fukano, hiroshi takase, tatsuya norii This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7054992/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 4 You are reading this latest preprint version Abstract Objective The American Society of Anesthesiologists (ASA) Physical Status Classification System is widely used to estimate procedural risk. However, its utility in adult emergency department (ED) patients undergoing procedural sedation and analgesia (PSA), particularly the elderly, remains unclear. This study evaluated the association between ASA classification and adverse events (AEs) during PSA, with a focus on patients aged ≥ 65 years. Methods This secondary analysis of a multicenter prospective registry (JPSTAR) included adult patients (≥ 18 years) who underwent PSA in the ED between 2017 and 2023. Patients were categorized into ASA I–II and ASA ≥ III groups. The primary outcome was the occurrence of any AE. Multivariable logistic regression was used to calculate adjusted odds ratios (aORs), controlling for clinical confounders. Subgroup analyses were performed by sedative type. Results Among 1,084 patients, 297 (27.4%) were classified as ASA ≥ III. The ASA ≥ III group was older than the ASA I–II group (median age: 76 vs. 68 years). The incidence of all AEs was higher in the ASA ≥ III group (26.9% vs. 17.9%; aOR: 1.48; 95% CI: 1.05–2.09). Hypoxia (SpO₂ < 90%) was the most common AE, especially in the ASA ≥ III group (14.5% vs. 9.4%). Among patients aged ≥ 65 years, ASA ≥ III remained significantly associated with AEs (aOR: 1.80; 95% CI: 1.22–2.68). Propofol use was associated with more AEs in ASA ≥ III patients (46.4% vs. 15.6%). Conclusion ASA ≥ III status is associated with increased AEs during PSA, particularly in elderly patients, Conscious Sedation / adverse effects* Japan Hypnotics and Sedatives / adverse effects* Aged Humans Figures Figure 1 Introduction Procedural sedation and analgesia (PSA) are widely used in emergency departments (EDs) to facilitate painful or anxiety-inducing procedures while maintaining patient safety and comfort [ 1 ]. Its use outside the operating room has increased significantly in recent years [ 2 ]. Although PSA is generally safe, it carries risks such as hypoxia, apnea, and hypotension [ 3 ]. Therefore, identifying predictors of PSA-related adverse events (AEs) is critical to improving patient safety in the emergency care environment. The American Society of Anesthesiologists (ASA) Physical Status Classification System is a widely accepted tool for assessing a patient’s preprocedural health status and estimating perioperative risk [ 4 ]. The ASA classification ranges from I to VI, with higher classes indicating more severe systemic disease or physical compromise. As such, the system helps clinicians predict perioperative risk based on a patient's overall medical condition. Notably, patients undergoing PSA outside the operating room, such as in EDs, tend to be older and have higher ASA classifications compared to patients treated in the operating room [ 2 , 5 ]. This population is often more acutely ill and medically complex, which may increase the likelihood of PSA-related complications. Current clinical guidelines suggest that patients classified as ASA III or higher are at elevated risk of AEs during PSA [ 1 , 6 , 7 ]. However, this recommendation is primarily based on evidence from pediatric populations1, where physiological characteristics and sedation responses differ markedly from those of adults. In adult ED patients, the relationship between ASA classification and PSA-related complications remains controversial [ 8 , 9 ]. In the ED, a variety of sedative agents—including ketamine, propofol, and benzodiazepines—are selected for PSA based on multiple factors such as procedure duration and characteristics, patient background, and the target depth of sedation [ 10 ]. Each sedative agent has a distinct AE profile. For instance, ketamine is associated with a low risk of respiratory AEs and may be preferentially selected for patients with tenuous airway status and higher ASA classifications [ 11 ]. However, the association between ASA classification and AEs has not been well established for individual sedative agents. We hypothesized that a higher ASA physical status would be associated with an increased risk of AEs during PSA. The aim of this study was to compare the incidence of PSA-related AEs between patients classified as ASA III or higher and those classified as ASA I or II. In addition, we sought to examine whether similar trends were observed among patients aged ≥ 65 years and across different types of sedative agents. Methods Study design This is a secondary analysis of a multicenter PSA patient registry in Japan. We examined data sourced from the Japanese Procedural Sedation and Analgesia Registry (JPSTAR), a prospective registry spanning multiple medical centers and focusing on ED patients undergoing PSA [ 12 ]. PSA was defined as "any systemic pharmacological intervention intended to facilitate a painful or uncomfortable procedure." JPSTAR encompasses information from patients of varying ages who underwent PSA administered by an emergency physician, whether within or outside the ED (e.g., in radiology and endoscopy suites). The JPSTAR investigators excluded patients who underwent airway management (e.g., endotracheal intubation) and those treated for delirium. At the time of the analysis, ten hospitals in Japan actively contributed to the registry. Previous findings from JPSTAR indicated that the ASA classification was I for 23.8%, II for 51.8%, III for 21.4%, and Ⅳ for 3%, respectively [ 12 ]. Data collection and management for the study were conducted using the REDCap system maintained by the University of New Mexico [ 13 , 14 ]. Regular data reviews at all JPSTAR sites ensure the inclusion of all eligible patients undergoing PSA. This study was approved by the institutional review boards of all participating hospitals. The requirement for informed consent was waived in accordance with Japanese government guidelines to ensure participant anonymity. Population We analyzed data from adult patients (aged 18 years or older) who received PSA in the ED between May 2017 and May 2023. We categorized patients into two groups: ASA I–II and ASA ≥ III, based on their ASA physical status classification. Measurements The primary outcome was the occurrence of any AE related to PSA. JPSTAR gathers reports for the following AEs: cardiac arrest, hypoxic ischemic brain injury, apnea (requiring an intervention, such as repositioning, jaw-thrust, or bag-valve-mask ventilation), glossoptosis, hypoxia (SpO2 180 mmHg), hypotension (systolic pressure 120 bpm), bradycardia (heart rate < 60 bpm), other dysrhythmias, agitation, prolonged sedation, nightmares, and local anesthetic toxicity. Statistical analyses Continuous variables were summarized using medians and interquartile ranges (IQR), while categorical variables were summarized as counts and percentages. Categorical comparisons were performed using the chi-square test, and continuous variables were compared using the Mann–Whitney U test. A two-tailed p-value of < 0.05 was considered statistically significant. All AEs were tested using logistic regression models, adjusting for age, sex, BMI, indication, supplemental oxygen use, sedatives, and overnight PSA (defined as procedures performed between 8:00 PM and 8:00 AM) based on clinical plausibility and a priori knowledge [ 15 , 16 , 17 ]. In addition, two subgroup analyses were conducted: one limited to patients aged ≥ 65 years, and the other based on the type of sedative used. Odds ratios with 95% confidence intervals (CIs) were calculated. Statistical analyses were performed using R version 4.4.0. Results There were 1833 patients in the registry between May 2017 to May 2023. Of those, we included 1084 patients in the analysis. A total of 787 patients (72.6%) were classified as the ASA I–II group, while 297 patients (27.4%) were classified as the ASA ≥ III group. (Fig. 1 ). The median age was higher in the ASA ≥ III group than in the ASA I–II group (76 years vs. 68 years). The primary indication for PSA in both groups was cardioversion, accounting for 72.4% in the ASA ≥ III group and 53.2% in the ASA I–II group. Fracture or dislocation reduction was more common in the ASA I–II group (21.9% vs. 4.4%). The most used sedative was thiopental, followed by propofol, midazolam, and ketamine. Fellows were significantly more involved in PSA for the ASA I–II group than for the ASA ≥ III group (35.7% vs. 28.3%) (Table 1 ). Table 1 Patient characteristic Variables ASA I–II , n = 787 ASA ≥ III , n = 297 P-value Age, years, median (IQR) 68 (52–77) 76 (66–84) < 0.001 Female, n (%) 331 (42.1) 133 (44.8) 0.46 BMI, median (IQR) 22.7 (20.8–25.1) 22.4 (20.2–25.4) 0.94 Indication, n (%) Cardioversion 419 (53.2) 215 (72.4) < 0.001 Fracture or dislocation reduction 172 (21.9) 13 (4.4) < 0.001 Gastrointestinal procedure 25 (3.2) 14 (4.7) 0.3 Others 171 (21.7) 55 (18.5) 0.28 Choice of sedatives, n (%) Thiopental 337 (42.8) 118 (39.7) 0.39 Propofol 251 (31.9) 112 (37.7) 0.082 Benzodiazepine (midazolam, diazepam) 113 (14.4) 45 (15.2) 0.82 Ketamine 61 (7.8) 9 (3.0) < 0.001 Other 25 (3.2) 13 (4.4) 0.44 PSA provider, n (%) Attending 492 (62.5) 210 (71.4) 0.071 Fellow 281 (35.7) 84 (28.3) 0.011 Others 14 (1.8) 3 (1.0) 0.43 Anesthesiology consultation, n (%) 49 (7.6) 27 (9.4) 0.15 Supplemental oxygen, n (%) 456 (57.9) 190 (64.0) 0.083 Time of procedure (20:00–07:59), n (%) 254 (32.3) 89 (30.0) 0.51 Procedure success, n (%) 712 (90.5) 266 (89.6) 0.74 IQR: Interquartile range, BMI: Body mass index, PSA: Procedural sedation and analgesia Table 2 summarizes the incidence of AEs by ASA physical status classification. The incidence of all AEs was higher in the ASA ≥ III group (26.9%) than in the ASA I–II group (17.9%). Hypoxia (SpO₂ < 90%) was the most frequently observed AE in both groups, occurring in 14.5% of patients in the ASA ≥ III group and 9.4% of those in the ASA I–II group. Table 2 Incidence of adverse events by American Society of Anesthesiologists Physical Status Classification Variables, n (%) ASA I–II , n = 787 ASA ≥ III , n = 297 P-value All adverse events 141 (17.9) 80 (26.9) 0.0011 Hypoxia (SpO2 < 90%) 74 (9.4) 43 (14.5) 0.022 Apnea 48 (6.1) 31 (10.4) 0.020 Hypotension (Systolic BP < 90 mm Hg) 12 (1.5) 13 (4.4) 0.010 Glossoptosis 32 (4.1) 20 (6.7) 0.094 Bradycardia (HR 180 mm Hg) 3 (0.4) 2 (0.7) 0.62 BP: blood pressure, HR: heart rate Table 3 presents the unadjusted and adjusted odds ratios (ORs) for all AEs comparing ASA ≥ III group with ASA I–II group. Patients in the ASA ≥ III group had significantly higher odds of experiencing all AEs (adjusted OR: 1.48; 95% CI: 1.05–2.09; p = 0.026). Table 3 Unadjusted and adjusted odds ratios for all adverse events in ASA ≥ III Patients compared to ASA I–II Population Unadjusted Odds Ratio (95% CI) P-value Adjusted Odds Ratio (95% CI) P-value All patients (≥ 18 years) 1.69 (1.23–2.31) 0.0011 1.48 (1.05–2.09) 0.026 Elderly patients (≥ 65 years) 1.76 (1.23–2.52) 0.0019 1.80 (1.22–2.68) 0.0033 Patient characteristics limited to those patients aged ≥ 65 years are presented in Supplementary Table 1. Table 4 shows the incidence of AEs stratified by patients aged ≥ 65 years. The incidence of all AEs was higher in the ASA ≥ III group (32.6%) than in the ASA I–II group (21.5%). As in the overall cohort, hypoxia was the most common AE in both groups. Similar results were observed in the subgroup of patients aged ≥ 65 years, with an adjusted OR of 1.80 (95% CI: 1.22–2.68; p = 0.0033) (Table 3 ). Table 4 Incidence of adverse events by elderly patients (≥ 65 Years) Variables, n (%) ASA I–II , n = 451 ASA ≥ III , n = 227 P-value All adverse events 97 (21.5) 74 (32.6) 0.0019 Hypoxia (SpO2 < 90%) 55 (12.2) 39 (17.2) 0.098 Apnea 33 (7.3) 30 (13.2) 0.018 Hypotension (Systolic BP < 90 mm Hg) 7 (1.6) 12 (5.3) 0.011 Glossoptosis 22 (4.9) 18 (7.9) 0.16 Bradycardia (HR 180 mm Hg) 1 (0.2) 2 (0.9) 0.54 BP: blood pressure, HR: heart rate Supplementary Table 2 shows the incidence of all AEs stratified by each sedative used (ketamine, benzodiazepines, propofol, and thiopental). Among all patients, the incidence of AEs with propofol use was higher in the ASA ≥ III group (46.4%) compared to the ASA I–II group (15.6%). This trend remained consistent among patients aged ≥ 65 years, where the incidence of AEs in the ASA ≥ III group was 52.7% compared to 20.7% in the ASA I–II group. Discussion In this multicenter, prospective study of adult patients undergoing PSA in EDs, we found that the median age was higher in the ASA ≥ III group compared to the ASA I–II group. Cardioversion was the most common indication for PSA in both groups. Among individual AEs, hypoxia was the most frequently observed, followed by apnea and glossoptosis in both groups. Multivariable analysis using logistic regression models demonstrated that the overall incidence of AEs was significantly higher in the ASA ≥ III group. This association remained significant even when the analysis was restricted to patients aged ≥ 65 years. Among each sedative used, only propofol was associated with a higher incidence of AEs in the ASA ≥ III group compared to the ASA I–II group. These findings align with clinical guidelines suggesting increased sedation risk in patients with ASA ≥ III [ 1 , 6 , 7 ]. However, most previous studies that informed such guidelines stem from pediatric studies [ 18 ], and evidence in adults has been inconsistent. A single-center study from the United Kingdom investigating adult patients undergoing hip dislocation reduction in the ED reported no association between higher ASA classification and AEs [ 19 ]. While this study offers valuable insight, its findings may not be generalizable due to the limited scope of the patient population, as it included only patients undergoing hip dislocation reduction. This specific focus does not reflect the broader range of procedures that typically requires PSA in the ED. Additionally, the study included a relatively small sample size of 348 patients and relied solely on univariate analysis, which may limit the internal validity of its conclusions. A retrospective study from the United States conducted in a non-operating room anesthesia setting also reported no association between ASA classification and AEs [ 9 ]. However, the applicability of these findings to ED settings may be limited, as only 11.5% of procedures in that study were performed in the ED. Moreover, the sedative regimen was restricted to benzodiazepines and opioids, which differ from the wider range of agents—such as propofol and ketamine—commonly used in ED-based PSA. These differences in clinical setting and pharmacological approach may partly explain the discrepancy in findings between that study and ours. In contrast, a large international observational study spanning 39 countries across six continents reported findings consistent with ours, showing that patients with ASA ≥ III had a significantly higher risk of AEs (adjusted odds ratio [aOR]: 1.89; 95% CI: 1.34–2.67) [ 8 ]. While this study supports our findings, the mean age of the study population was relatively young at 33 years, limiting its generalizability to older adults. By comparison, this study included a large proportion of elderly patients, reflecting the aging demographic in Japan. Moreover, in an analysis limited to patients aged ≥ 65 years, the ASA ≥ III group remained significantly associated with an increased risk of AEs. These results reinforce the clinical relevance of ASA classification in risk stratification for PSA in adult ED patients, particularly in older populations. In the subgroup analysis, the incidence of both overall AEs and hypoxia with propofol use was higher in the ASA ≥ III group than in the ASA I–II group, both in the overall cohort and among those aged ≥ 65 years. These findings are consistent with previous studies, including a report showing that among patients aged ≥ 65 years, propofol use was associated with a significantly higher incidence of AEs (16% vs. 31.2%, P = 0.027) [ 20 ]. Furthermore, clinical practice guidelines recommend caution when using propofol for PSA in elderly or ASA ≥ III, suggesting an initial dose ≤ 0.5 mg/kg to mitigate complication risk [ 21 ]. Taken together, our findings reinforce the importance of tailoring sedative choice and dosing strategies based on patient risk profiles, particularly in medically complex or older adults undergoing PSA in the ED. One strength of this study is that it was conducted in Japan, one of the most rapidly aging countries in the world, with a study population consisting largely of older adults. In addition, the multicenter prospective design enhances the generalizability and reliability of our findings. We note several limitations to this study. First, the level of sedation depth, which may influence the risk of AEs, was not recorded in the registry, limiting our ability to adjust for this potentially important confounder. However, indications for PSA (e.g., cardioversion) that are often associated with depth of sedation were included in the model and adjusted accordingly. Second, data were reported by treating physicians, which introduces the possibility of reporting bias. To mitigate this, site investigators cross-checked registry entries with nursing records. However, variability in monitoring practices remains a concern. The type and frequency of physiological monitoring were determined by the individual physician performing PSA. Notably, capnography, which enables detection of transient apnea, is not routinely used in Japanese EDs, with reported usage rates varying widely from 0–73.8% [ 22 ], potentially leading to underreporting of apnea. However, a previous study reported that the addition of capnography to standard monitoring did not reduce the incidence of AEs during PSA in the ED [ 23 ]. Therefore, we conducted a multivariable analysis redefining all AEs to exclude apnea. The results remained consistent with the primary analysis, with an adjusted odds ratio of 1.54 (95% CI: 1.02–2.31; p = 0.039). Third, ASA physical status was assessed by a single emergency physician at each site, and previous studies have shown only moderate agreement even among anesthesiologists, suggesting possible misclassification [ 24 ]. However, site investigators reviewed registry entries, effectively providing a double-check to enhance reliability. Finally, the study population consisted exclusively of Japanese patients. Therefore, caution should be exercised when generalizing the findings to other populations with different demographics or healthcare practices. In conclusion, among ED patients undergoing PSA, those classified as ASA ≥ III, particularly elderly patients aged ≥ 65 years, had a significantly higher incidence of all adverse events compared to those with ASA I–II. The incidence of adverse events was higher when propofol was used, with hypoxia being the most common event in both groups. These findings highlight the importance of careful risk stratification and sedative selection in elderly patients undergoing PSA in the ED. Declarations Approval number of the research protocol with approval No. 18-68 and committee Name: The protocol was approved by the Institutional Review Board of Fukui Prefectural Hospital. Informed consent: The requirement for informed consent of the patients was waived. Registry and the registration no. of the study/trial: N/A. Conflict of interest: The authors declare they have no financial interests. Source of funding: The authors did not receive support from any organization for the submitted work. Author contribution: All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by MH. The first draft of the manuscript was written by MH and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript. Data availability: The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Acknowledgements We thank the JPSTAR and all personnel at participating institutions who contributed the data. References Green SM, Roback MG, Krauss BS, Miner JR, Schneider S, Kivela PD, Nelson LS, Chumpitazi CE, Fisher JD, Gesek D, Jackson B, Kamat P, Kowalenko T, Lewis B, Papo M, Phillips D, Ruff S, Runde D, Tobin T, Vafaie N, Vargo J 2nd, Walser E, Yealy DM, O'Connor RE. Unscheduled Procedural Sedation: A Multidisciplinary Consensus Practice Guideline. Ann Emerg Med. 2019;73:e51-e65. doi: 10.1016/j.annemergmed.2019.02.022. Nagrebetsky A, Gabriel RA, Dutton RP, Urman RD. 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hayashi","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA80lEQVRIie2RvUoDQRCA5zjZaybaziJeXiFyjeJhXiVDYG0kTV5gq+nSp/MtwpUrB1b7AilDIJ1gmkCKoJcQ0SbL2QnZrxqG+Zg/gEjkH5JZBcAWQHWXDhJ7TFNAQXdULsEM/qDsK3N47v0oIZCMoUVVjhT4DW2rMoesdnBfBZU3Ym/GKpnM9MSbArCZUPvTSp+ehFhqlrQzo04TWMIeaAl1OSifLApXetdO2Q8mjgVRXbfrgqvhHfshC6ni4UZMoZpdXGgXzMztfFs98ss0Xczfpcyvsvp1qQMX+83F4YHNn6DWtp2SfnxHybqlEolEImfBF4kjTDIcZE8dAAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0002-0160-6288","institution":"Fukui Prefectural Hospital: Fukui Kenritsu Byoin","correspondingAuthor":true,"prefix":"","firstName":"minoru","middleName":"","lastName":"hayashi","suffix":""},{"id":515724673,"identity":"850beaee-788a-48ab-a324-385da318d5ac","order_by":1,"name":"kentaro fukano","email":"","orcid":"","institution":"Jichi Ika University Saitama Medical Center: Jichi Ika Daigaku Fuzoku Saitama Iryo Center","correspondingAuthor":false,"prefix":"","firstName":"kentaro","middleName":"","lastName":"fukano","suffix":""},{"id":515724674,"identity":"dffc4d75-b4cc-4af0-bc2f-ecf4f39d8e0a","order_by":2,"name":"hiroshi takase","email":"","orcid":"","institution":"Sendai City Hospital","correspondingAuthor":false,"prefix":"","firstName":"hiroshi","middleName":"","lastName":"takase","suffix":""},{"id":515724675,"identity":"b04249f3-3d01-4775-a725-0ffe59806596","order_by":3,"name":"tatsuya norii","email":"","orcid":"","institution":"University of New Mexico Health Sciences Center","correspondingAuthor":false,"prefix":"","firstName":"tatsuya","middleName":"","lastName":"norii","suffix":""}],"badges":[],"createdAt":"2025-07-05 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13:13:31","extension":"html","order_by":9,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":115648,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-7054992/v1/27c8d2e93dff57b5ce5be060.html"},{"id":92086769,"identity":"6f2a208c-fb4a-4321-84b5-22d86347d8b6","added_by":"auto","created_at":"2025-09-24 13:05:31","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":121346,"visible":true,"origin":"","legend":"\u003cp\u003eStudy participant flow\u003c/p\u003e\n\u003cp\u003eThere were 1833 patients in the registry between May 2017 to May 2023. Of those, we included 1084 patients in the analysis. A total of 787 patients (72.6%) were classified as the ASA I–II group, while 297 patients (27.4%) were classified as the ASA ≥III group.\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-7054992/v1/9f8cf350cfe2d945c28ce3a9.jpeg"},{"id":92088533,"identity":"86d34b33-c286-4f39-b925-a8a46fc4b3c2","added_by":"auto","created_at":"2025-09-24 13:13:35","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":654715,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7054992/v1/4804d417-7c44-4847-ae3c-0b7fcb9766ee.pdf"}],"financialInterests":"","formattedTitle":"Incidence of adverse events during emergency department procedural sedation by ASA Physical Status Classification: a multicenter prospective study","fulltext":[{"header":"Introduction","content":"\u003cp\u003eProcedural sedation and analgesia (PSA) are widely used in emergency departments (EDs) to facilitate painful or anxiety-inducing procedures while maintaining patient safety and comfort [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Its use outside the operating room has increased significantly in recent years [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Although PSA is generally safe, it carries risks such as hypoxia, apnea, and hypotension [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Therefore, identifying predictors of PSA-related adverse events (AEs) is critical to improving patient safety in the emergency care environment.\u003c/p\u003e\u003cp\u003eThe American Society of Anesthesiologists (ASA) Physical Status Classification System is a widely accepted tool for assessing a patient’s preprocedural health status and estimating perioperative risk [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. The ASA classification ranges from I to VI, with higher classes indicating more severe systemic disease or physical compromise. As such, the system helps clinicians predict perioperative risk based on a patient's overall medical condition. Notably, patients undergoing PSA outside the operating room, such as in EDs, tend to be older and have higher ASA classifications compared to patients treated in the operating room [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. This population is often more acutely ill and medically complex, which may increase the likelihood of PSA-related complications.\u003c/p\u003e\u003cp\u003eCurrent clinical guidelines suggest that patients classified as ASA III or higher are at elevated risk of AEs during PSA [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. However, this recommendation is primarily based on evidence from pediatric populations1, where physiological characteristics and sedation responses differ markedly from those of adults. In adult ED patients, the relationship between ASA classification and PSA-related complications remains controversial [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eIn the ED, a variety of sedative agents—including ketamine, propofol, and benzodiazepines—are selected for PSA based on multiple factors such as procedure duration and characteristics, patient background, and the target depth of sedation [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Each sedative agent has a distinct AE profile. For instance, ketamine is associated with a low risk of respiratory AEs and may be preferentially selected for patients with tenuous airway status and higher ASA classifications [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. However, the association between ASA classification and AEs has not been well established for individual sedative agents.\u003c/p\u003e\u003cp\u003eWe hypothesized that a higher ASA physical status would be associated with an increased risk of AEs during PSA. The aim of this study was to compare the incidence of PSA-related AEs between patients classified as ASA III or higher and those classified as ASA I or II. In addition, we sought to examine whether similar trends were observed among patients aged ≥ 65 years and across different types of sedative agents.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eStudy design\u003c/p\u003e\u003cp\u003eThis is a secondary analysis of a multicenter PSA patient registry in Japan. We examined data sourced from the Japanese Procedural Sedation and Analgesia Registry (JPSTAR), a prospective registry spanning multiple medical centers and focusing on ED patients undergoing PSA [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. PSA was defined as \"any systemic pharmacological intervention intended to facilitate a painful or uncomfortable procedure.\" JPSTAR encompasses information from patients of varying ages who underwent PSA administered by an emergency physician, whether within or outside the ED (e.g., in radiology and endoscopy suites). The JPSTAR investigators excluded patients who underwent airway management (e.g., endotracheal intubation) and those treated for delirium. At the time of the analysis, ten hospitals in Japan actively contributed to the registry. Previous findings from JPSTAR indicated that the ASA classification was I for 23.8%, II for 51.8%, III for 21.4%, and Ⅳ for 3%, respectively [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Data collection and management for the study were conducted using the REDCap system maintained by the University of New Mexico [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Regular data reviews at all JPSTAR sites ensure the inclusion of all eligible patients undergoing PSA. This study was approved by the institutional review boards of all participating hospitals. The requirement for informed consent was waived in accordance with Japanese government guidelines to ensure participant anonymity.\u003c/p\u003e\u003cp\u003ePopulation\u003c/p\u003e\u003cp\u003eWe analyzed data from adult patients (aged 18 years or older) who received PSA in the ED between May 2017 and May 2023. We categorized patients into two groups: ASA I–II and ASA ≥ III, based on their ASA physical status classification.\u003c/p\u003e\u003cp\u003eMeasurements\u003c/p\u003e\u003cp\u003eThe primary outcome was the occurrence of any AE related to PSA. JPSTAR gathers reports for the following AEs: cardiac arrest, hypoxic ischemic brain injury, apnea (requiring an intervention, such as repositioning, jaw-thrust, or bag-valve-mask ventilation), glossoptosis, hypoxia (SpO2 \u0026lt; 90%), laryngeal spasm, hypersalivation, hypertension (systolic pressure \u0026gt; 180 mmHg), hypotension (systolic pressure \u0026lt; 90 mmHg), tachycardia (heart rate \u0026gt; 120 bpm), bradycardia (heart rate \u0026lt; 60 bpm), other dysrhythmias, agitation, prolonged sedation, nightmares, and local anesthetic toxicity.\u003c/p\u003e\u003cp\u003eStatistical analyses\u003c/p\u003e\u003cp\u003eContinuous variables were summarized using medians and interquartile ranges (IQR), while categorical variables were summarized as counts and percentages. Categorical comparisons were performed using the chi-square test, and continuous variables were compared using the Mann–Whitney U test. A two-tailed p-value of \u0026lt; 0.05 was considered statistically significant. All AEs were tested using logistic regression models, adjusting for age, sex, BMI, indication, supplemental oxygen use, sedatives, and overnight PSA (defined as procedures performed between 8:00 PM and 8:00 AM) based on clinical plausibility and a priori knowledge [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. In addition, two subgroup analyses were conducted: one limited to patients aged ≥ 65 years, and the other based on the type of sedative used. Odds ratios with 95% confidence intervals (CIs) were calculated. Statistical analyses were performed using R version 4.4.0.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eThere were 1833 patients in the registry between May 2017 to May 2023. Of those, we included 1084 patients in the analysis. A total of 787 patients (72.6%) were classified as the ASA I\u0026ndash;II group, while 297 patients (27.4%) were classified as the ASA\u0026thinsp;\u0026ge;\u0026thinsp;III group. (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eThe median age was higher in the ASA\u0026thinsp;\u0026ge;\u0026thinsp;III group than in the ASA I\u0026ndash;II group (76 years vs. 68 years). The primary indication for PSA in both groups was cardioversion, accounting for 72.4% in the ASA\u0026thinsp;\u0026ge;\u0026thinsp;III group and 53.2% in the ASA I\u0026ndash;II group. Fracture or dislocation reduction was more common in the ASA I\u0026ndash;II group (21.9% vs. 4.4%). The most used sedative was thiopental, followed by propofol, midazolam, and ketamine. Fellows were significantly more involved in PSA for the ASA I\u0026ndash;II group than for the ASA\u0026thinsp;\u0026ge;\u0026thinsp;III group (35.7% vs. 28.3%) (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\u003ePatient characteristic\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\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\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVariables\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eASA I\u0026ndash;II\u003c/p\u003e\u003cp\u003e, n\u0026thinsp;=\u0026thinsp;787\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eASA\u0026thinsp;\u0026ge;\u0026thinsp;III\u003c/p\u003e\u003cp\u003e, n\u0026thinsp;=\u0026thinsp;297\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eP-value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge, years, median (IQR)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e68 (52\u0026ndash;77)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e76 (66\u0026ndash;84)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFemale, n (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e331 (42.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e133 (44.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.46\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBMI, median (IQR)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e22.7 (20.8\u0026ndash;25.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e22.4 (20.2\u0026ndash;25.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.94\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eIndication, n (%)\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\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCardioversion\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e419 (53.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e215 (72.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFracture or dislocation reduction\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e172 (21.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e13 (4.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGastrointestinal procedure\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e25 (3.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e14 (4.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.3\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOthers\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e171 (21.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e55 (18.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.28\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e\u003cp\u003eChoice of sedatives, n (%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eThiopental\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e337 (42.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e118 (39.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.39\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePropofol\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e251 (31.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e112 (37.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.082\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBenzodiazepine (midazolam, diazepam)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e113 (14.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e45 (15.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.82\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eKetamine\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e61 (7.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e9 (3.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOther\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e25 (3.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e13 (4.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.44\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e\u003cp\u003ePSA provider, n (%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAttending\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e492 (62.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e210 (71.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.071\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFellow\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e281 (35.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e84 (28.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.011\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOthers\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e14 (1.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e3 (1.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.43\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAnesthesiology consultation, n (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e49 (7.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e27 (9.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.15\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSupplemental oxygen, n (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e456 (57.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e190 (64.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.083\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTime of procedure (20:00\u0026ndash;07:59), n (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e254 (32.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e89 (30.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.51\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eProcedure success, n (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e712 (90.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e266 (89.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.74\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"4\"\u003eIQR: Interquartile range, BMI: Body mass index, PSA: Procedural sedation and analgesia\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e summarizes the incidence of AEs by ASA physical status classification. The incidence of all AEs was higher in the ASA\u0026thinsp;\u0026ge;\u0026thinsp;III group (26.9%) than in the ASA I\u0026ndash;II group (17.9%). Hypoxia (SpO₂ \u0026lt; 90%) was the most frequently observed AE in both groups, occurring in 14.5% of patients in the ASA\u0026thinsp;\u0026ge;\u0026thinsp;III group and 9.4% of those in the ASA I\u0026ndash;II group.\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\u003eIncidence of adverse events by American Society of Anesthesiologists Physical Status Classification\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVariables, n (%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eASA I\u0026ndash;II\u003c/p\u003e\u003cp\u003e, n\u0026thinsp;=\u0026thinsp;787\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eASA\u0026thinsp;\u0026ge;\u0026thinsp;III\u003c/p\u003e\u003cp\u003e, n\u0026thinsp;=\u0026thinsp;297\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eP-value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAll adverse events\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e141 (17.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e80 (26.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.0011\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHypoxia (SpO2\u0026thinsp;\u0026lt;\u0026thinsp;90%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e74 (9.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e43 (14.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.022\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eApnea\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e48 (6.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e31 (10.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.020\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHypotension (Systolic BP\u0026thinsp;\u0026lt;\u0026thinsp;90 mm Hg)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e12 (1.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e13 (4.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.010\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGlossoptosis\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e32 (4.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e20 (6.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.094\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBradycardia (HR\u0026thinsp;\u0026lt;\u0026thinsp;60 beats/min)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e2 (0.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e7 (2.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.0052\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVomiting\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e8 (1.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e1 (0.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.46\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAgitation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e3 (0.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e1 (0.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e1.0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHypertension (Systolic BP\u0026thinsp;\u0026gt;\u0026thinsp;180 mm Hg)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e3 (0.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e2 (0.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.62\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"4\"\u003eBP: blood pressure, HR: heart rate\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e presents the unadjusted and adjusted odds ratios (ORs) for all AEs comparing ASA\u0026thinsp;\u0026ge;\u0026thinsp;III group with ASA I\u0026ndash;II group. Patients in the ASA\u0026thinsp;\u0026ge;\u0026thinsp;III group had significantly higher odds of experiencing all AEs (adjusted OR: 1.48; 95% CI: 1.05\u0026ndash;2.09; p\u0026thinsp;=\u0026thinsp;0.026).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eUnadjusted and adjusted odds ratios for all adverse events in ASA\u0026thinsp;\u0026ge;\u0026thinsp;III Patients compared to ASA I\u0026ndash;II\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePopulation\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eUnadjusted Odds Ratio (95% CI)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eP-value\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eAdjusted Odds Ratio (95% CI)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eP-value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAll patients (\u0026ge;\u0026thinsp;18 years)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e1.69 (1.23\u0026ndash;2.31)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0.0011\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e1.48 (1.05\u0026ndash;2.09)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.026\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eElderly patients (\u0026ge;\u0026thinsp;65 years)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e1.76 (1.23\u0026ndash;2.52)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0.0019\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e1.80 (1.22\u0026ndash;2.68)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.0033\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\u003ePatient characteristics limited to those patients aged\u0026thinsp;\u0026ge;\u0026thinsp;65 years are presented in Supplementary Table\u0026nbsp;1. Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e shows the incidence of AEs stratified by patients aged\u0026thinsp;\u0026ge;\u0026thinsp;65 years. The incidence of all AEs was higher in the ASA\u0026thinsp;\u0026ge;\u0026thinsp;III group (32.6%) than in the ASA I\u0026ndash;II group (21.5%). As in the overall cohort, hypoxia was the most common AE in both groups. Similar results were observed in the subgroup of patients aged\u0026thinsp;\u0026ge;\u0026thinsp;65 years, with an adjusted OR of 1.80 (95% CI: 1.22\u0026ndash;2.68; p\u0026thinsp;=\u0026thinsp;0.0033) (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eIncidence of adverse events by elderly patients (\u0026ge;\u0026thinsp;65 Years)\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVariables, n (%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eASA I\u0026ndash;II\u003c/p\u003e\u003cp\u003e, n\u0026thinsp;=\u0026thinsp;451\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eASA\u0026thinsp;\u0026ge;\u0026thinsp;III\u003c/p\u003e\u003cp\u003e, n\u0026thinsp;=\u0026thinsp;227\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eP-value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAll adverse events\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e97 (21.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e74 (32.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.0019\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHypoxia (SpO2\u0026thinsp;\u0026lt;\u0026thinsp;90%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e55 (12.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e39 (17.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.098\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eApnea\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e33 (7.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e30 (13.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.018\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHypotension (Systolic BP\u0026thinsp;\u0026lt;\u0026thinsp;90 mm Hg)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e7 (1.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e12 (5.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.011\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGlossoptosis\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e22 (4.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e18 (7.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.16\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBradycardia (HR\u0026thinsp;\u0026lt;\u0026thinsp;60 beats/min)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e1 (0.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e7 (3.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.013\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVomiting\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e6 (1.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e1 (0.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.50\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAgitation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e1 (0.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e1 (0.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e1.0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHypertension (Systolic BP\u0026thinsp;\u0026gt;\u0026thinsp;180 mm Hg)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e1 (0.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e2 (0.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.54\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"4\"\u003eBP: blood pressure, HR: heart rate\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eSupplementary Table\u0026nbsp;2 shows the incidence of all AEs stratified by each sedative used (ketamine, benzodiazepines, propofol, and thiopental). Among all patients, the incidence of AEs with propofol use was higher in the ASA\u0026thinsp;\u0026ge;\u0026thinsp;III group (46.4%) compared to the ASA I\u0026ndash;II group (15.6%). This trend remained consistent among patients aged\u0026thinsp;\u0026ge;\u0026thinsp;65 years, where the incidence of AEs in the ASA\u0026thinsp;\u0026ge;\u0026thinsp;III group was 52.7% compared to 20.7% in the ASA I\u0026ndash;II group.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eIn this multicenter, prospective study of adult patients undergoing PSA in EDs, we found that the median age was higher in the ASA\u0026thinsp;\u0026ge;\u0026thinsp;III group compared to the ASA I\u0026ndash;II group. Cardioversion was the most common indication for PSA in both groups. Among individual AEs, hypoxia was the most frequently observed, followed by apnea and glossoptosis in both groups. Multivariable analysis using logistic regression models demonstrated that the overall incidence of AEs was significantly higher in the ASA\u0026thinsp;\u0026ge;\u0026thinsp;III group. This association remained significant even when the analysis was restricted to patients aged\u0026thinsp;\u0026ge;\u0026thinsp;65 years. Among each sedative used, only propofol was associated with a higher incidence of AEs in the ASA\u0026thinsp;\u0026ge;\u0026thinsp;III group compared to the ASA I\u0026ndash;II group.\u003c/p\u003e\u003cp\u003eThese findings align with clinical guidelines suggesting increased sedation risk in patients with ASA\u0026thinsp;\u0026ge;\u0026thinsp;III [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. However, most previous studies that informed such guidelines stem from pediatric studies [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e], and evidence in adults has been inconsistent. A single-center study from the United Kingdom investigating adult patients undergoing hip dislocation reduction in the ED reported no association between higher ASA classification and AEs [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. While this study offers valuable insight, its findings may not be generalizable due to the limited scope of the patient population, as it included only patients undergoing hip dislocation reduction. This specific focus does not reflect the broader range of procedures that typically requires PSA in the ED. Additionally, the study included a relatively small sample size of 348 patients and relied solely on univariate analysis, which may limit the internal validity of its conclusions. A retrospective study from the United States conducted in a non-operating room anesthesia setting also reported no association between ASA classification and AEs [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. However, the applicability of these findings to ED settings may be limited, as only 11.5% of procedures in that study were performed in the ED. Moreover, the sedative regimen was restricted to benzodiazepines and opioids, which differ from the wider range of agents\u0026mdash;such as propofol and ketamine\u0026mdash;commonly used in ED-based PSA. These differences in clinical setting and pharmacological approach may partly explain the discrepancy in findings between that study and ours. In contrast, a large international observational study spanning 39 countries across six continents reported findings consistent with ours, showing that patients with ASA\u0026thinsp;\u0026ge;\u0026thinsp;III had a significantly higher risk of AEs (adjusted odds ratio [aOR]: 1.89; 95% CI: 1.34\u0026ndash;2.67) [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. While this study supports our findings, the mean age of the study population was relatively young at 33 years, limiting its generalizability to older adults. By comparison, this study included a large proportion of elderly patients, reflecting the aging demographic in Japan. Moreover, in an analysis limited to patients aged\u0026thinsp;\u0026ge;\u0026thinsp;65 years, the ASA\u0026thinsp;\u0026ge;\u0026thinsp;III group remained significantly associated with an increased risk of AEs. These results reinforce the clinical relevance of ASA classification in risk stratification for PSA in adult ED patients, particularly in older populations.\u003c/p\u003e\u003cp\u003eIn the subgroup analysis, the incidence of both overall AEs and hypoxia with propofol use was higher in the ASA\u0026thinsp;\u0026ge;\u0026thinsp;III group than in the ASA I\u0026ndash;II group, both in the overall cohort and among those aged\u0026thinsp;\u0026ge;\u0026thinsp;65 years. These findings are consistent with previous studies, including a report showing that among patients aged\u0026thinsp;\u0026ge;\u0026thinsp;65 years, propofol use was associated with a significantly higher incidence of AEs (16% vs. 31.2%, P\u0026thinsp;=\u0026thinsp;0.027) [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. Furthermore, clinical practice guidelines recommend caution when using propofol for PSA in elderly or ASA\u0026thinsp;\u0026ge;\u0026thinsp;III, suggesting an initial dose\u0026thinsp;\u0026le;\u0026thinsp;0.5 mg/kg to mitigate complication risk [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Taken together, our findings reinforce the importance of tailoring sedative choice and dosing strategies based on patient risk profiles, particularly in medically complex or older adults undergoing PSA in the ED.\u003c/p\u003e\u003cp\u003eOne strength of this study is that it was conducted in Japan, one of the most rapidly aging countries in the world, with a study population consisting largely of older adults. In addition, the multicenter prospective design enhances the generalizability and reliability of our findings.\u003c/p\u003e\u003cp\u003eWe note several limitations to this study. First, the level of sedation depth, which may influence the risk of AEs, was not recorded in the registry, limiting our ability to adjust for this potentially important confounder. However, indications for PSA (e.g., cardioversion) that are often associated with depth of sedation were included in the model and adjusted accordingly. Second, data were reported by treating physicians, which introduces the possibility of reporting bias. To mitigate this, site investigators cross-checked registry entries with nursing records. However, variability in monitoring practices remains a concern. The type and frequency of physiological monitoring were determined by the individual physician performing PSA. Notably, capnography, which enables detection of transient apnea, is not routinely used in Japanese EDs, with reported usage rates varying widely from 0\u0026ndash;73.8% [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e], potentially leading to underreporting of apnea. However, a previous study reported that the addition of capnography to standard monitoring did not reduce the incidence of AEs during PSA in the ED [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. Therefore, we conducted a multivariable analysis redefining all AEs to exclude apnea. The results remained consistent with the primary analysis, with an adjusted odds ratio of 1.54 (95% CI: 1.02\u0026ndash;2.31; p\u0026thinsp;=\u0026thinsp;0.039). Third, ASA physical status was assessed by a single emergency physician at each site, and previous studies have shown only moderate agreement even among anesthesiologists, suggesting possible misclassification [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. However, site investigators reviewed registry entries, effectively providing a double-check to enhance reliability. Finally, the study population consisted exclusively of Japanese patients. Therefore, caution should be exercised when generalizing the findings to other populations with different demographics or healthcare practices.\u003c/p\u003e\u003cp\u003eIn conclusion, among ED patients undergoing PSA, those classified as ASA\u0026thinsp;\u0026ge;\u0026thinsp;III, particularly elderly patients aged\u0026thinsp;\u0026ge;\u0026thinsp;65 years, had a significantly higher incidence of all adverse events compared to those with ASA I\u0026ndash;II. The incidence of adverse events was higher when propofol was used, with hypoxia being the most common event in both groups. These findings highlight the importance of careful risk stratification and sedative selection in elderly patients undergoing PSA in the ED.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eApproval number of the research protocol with approval No. 18-68 and committee Name: The protocol was approved by the Institutional Review Board of Fukui Prefectural Hospital.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eInformed consent: The requirement for informed consent of the patients was waived.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eRegistry and the registration no. of the study/trial: N/A.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eConflict of interest: The authors declare they have no financial interests.\u003c/p\u003e\n\u003cp\u003eSource of funding: The authors did not receive support from any organization for the submitted work.\u003c/p\u003e\n\u003cp\u003eAuthor contribution: All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by MH. The first draft of the manuscript was written by MH and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003eData availability: The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\u003ch2\u003eAcknowledgements\u003c/h2\u003e\u003cp\u003eWe thank the JPSTAR and all personnel at participating institutions who contributed the data.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eGreen SM, Roback MG, Krauss BS, Miner JR, Schneider S, Kivela PD, Nelson LS, Chumpitazi CE, Fisher JD, Gesek D, Jackson B, Kamat P, Kowalenko T, Lewis B, Papo M, Phillips D, Ruff S, Runde D, Tobin T, Vafaie N, Vargo J 2nd, Walser E, Yealy DM, O\u0026apos;Connor RE. 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PMID: 21912242.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"internal-and-emergency-medicine","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"iaem","sideBox":"Learn more about [Internal and Emergency Medicine](http://link.springer.com/journal/11739)","snPcode":"11739","submissionUrl":"https://www.editorialmanager.com/iaem/default.aspx","title":"Internal and Emergency Medicine","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Conscious Sedation / adverse effects*, Japan, Hypnotics and Sedatives / adverse effects*, Aged, Humans","lastPublishedDoi":"10.21203/rs.3.rs-7054992/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7054992/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eObjective\u003c/h2\u003e\u003cp\u003eThe American Society of Anesthesiologists (ASA) Physical Status Classification System is widely used to estimate procedural risk. However, its utility in adult emergency department (ED) patients undergoing procedural sedation and analgesia (PSA), particularly the elderly, remains unclear. This study evaluated the association between ASA classification and adverse events (AEs) during PSA, with a focus on patients aged\u0026thinsp;\u0026ge;\u0026thinsp;65 years.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eThis secondary analysis of a multicenter prospective registry (JPSTAR) included adult patients (\u0026ge;\u0026thinsp;18 years) who underwent PSA in the ED between 2017 and 2023. Patients were categorized into ASA I\u0026ndash;II and ASA\u0026thinsp;\u0026ge;\u0026thinsp;III groups. The primary outcome was the occurrence of any AE. Multivariable logistic regression was used to calculate adjusted odds ratios (aORs), controlling for clinical confounders. Subgroup analyses were performed by sedative type.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eAmong 1,084 patients, 297 (27.4%) were classified as ASA\u0026thinsp;\u0026ge;\u0026thinsp;III. The ASA\u0026thinsp;\u0026ge;\u0026thinsp;III group was older than the ASA I\u0026ndash;II group (median age: 76 vs. 68 years). The incidence of all AEs was higher in the ASA\u0026thinsp;\u0026ge;\u0026thinsp;III group (26.9% vs. 17.9%; aOR: 1.48; 95% CI: 1.05\u0026ndash;2.09). Hypoxia (SpO₂ \u0026lt; 90%) was the most common AE, especially in the ASA\u0026thinsp;\u0026ge;\u0026thinsp;III group (14.5% vs. 9.4%). Among patients aged\u0026thinsp;\u0026ge;\u0026thinsp;65 years, ASA\u0026thinsp;\u0026ge;\u0026thinsp;III remained significantly associated with AEs (aOR: 1.80; 95% CI: 1.22\u0026ndash;2.68). Propofol use was associated with more AEs in ASA\u0026thinsp;\u0026ge;\u0026thinsp;III patients (46.4% vs. 15.6%).\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e\u003cp\u003eASA\u0026thinsp;\u0026ge;\u0026thinsp;III status is associated with increased AEs during PSA, particularly in elderly patients,\u003c/p\u003e","manuscriptTitle":"Incidence of adverse events during emergency department procedural sedation by ASA Physical Status Classification: a multicenter prospective study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-24 13:05:26","doi":"10.21203/rs.3.rs-7054992/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2025-09-16T16:52:41+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-09-16T06:52:07+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-07-08T11:27:56+00:00","index":"","fulltext":""},{"type":"submitted","content":"Internal and Emergency Medicine","date":"2025-07-07T19:47:29+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"internal-and-emergency-medicine","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"iaem","sideBox":"Learn more about [Internal and Emergency Medicine](http://link.springer.com/journal/11739)","snPcode":"11739","submissionUrl":"https://www.editorialmanager.com/iaem/default.aspx","title":"Internal and Emergency Medicine","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"0a112af4-44af-498b-af64-95f7196cdb69","owner":[],"postedDate":"September 24th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2025-12-10T01:10:29+00:00","versionOfRecord":[],"versionCreatedAt":"2025-09-24 13:05:26","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7054992","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7054992","identity":"rs-7054992","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}