Effects of adding low-dose esketamine to sufentanil and propofol sedation during cervical conization: a prospective, single-center, randomized controlled trial

Background: Cervical conization is a brief but painful procedure that can be performed under deep sedation with propofol and opioids. However, this sedation approach comes with a high risk of sedation-related adverse events (SRAEs). Esketamine, an N -methyl-d-aspartate (NMDA) receptor antagonist, has the property of less cardiorespiratory depression than opioids. The aim of this study was to assess the efficacy and safety of adding a low-dose esketamine to propofol and sufentanil sedation as an opioid-reduced regimen. Methods 122 consecutive patients with ASA Ⅰ-Ⅲ, body mass index < 30, STOP-BANG score < 3 who underwent cervical conization were enrolled and randomly divided into group S and group ES. Using a closed-loop target-controlled infusion (TCI) pump with target bispectral index (BIS) value of 60 ± 5, patients in group S were sedated with 0.2µg/kg sufentanil and propofol, while patients in group ES were sedated with 0.15mg/kg esketamine, 0.1µg/kg sufentanil and propofol. The primary endpoint was the composite incidence of SRAEs, while the second endpoints included effectiveness of sedation, awakening time, psychotomimetic side effects, postoperative pain, postoperative nausea and vomiting, and patient and gynecologist satisfaction. Results Data of 120 patients were analyzed. The incidence of composite SRAEs was significantly higher in group S compared to group ES (85.0% vs 56.7%, P  < 0.05). Furthermore, the severity of SRAEs was higher in group S compared to group ES ( P  < 0.001). There were no significant differences in the success of sedation, awakening time, psychotomimetic side effects, postoperative nausea and vomiting, postoperative pain, and patient and gynecologist satisfaction between the two groups. Conclusion Adding a low-dose esketamine to propofol and sufentanil sedation reduces the incidence and severity of SRAEs in patients undergoing cervical conization, with equal sedation efficacy, recovery quality, and no additional psychomimetic side effects. Trial registration ChiCTR2000040457, 28/11/2020