Safety and Efficacy of Remimazolam Combined with Esketamine for Anesthesia in Elderly Patients Undergoing ERCP: A Randomized Controlled Trial.

Abstract

Objective Older adults undergoing ERCP are particularly susceptible to sedation-related respiratory and circulatory adverse events. This trial compared the safety and efficacy of remimazolam-esketamine with propofol-fentanyl, with identical standardized nasopharyngeal airway-assisted respiratory management in both groups. Patients and Methods This single-center, prospective, randomized, parallel-group superiority trial enrolled 160 patients aged 60-80 years with American Society of Anesthesiologists physical status I-III who were scheduled for elective ERCP. Participants were randomly assigned 1:1 to remimazolam-esketamine (RE group; n=80) or propofol-fentanyl (PF group; n=80). Both groups received identical nasopharyngeal airway placement, oxygen delivery, capnography, and rescue algorithms; the randomized intervention was the anesthetic drug regimen. The primary outcome was composite sedation-related adverse events (SRAEs), comprising prespecified hypotension, bradycardia, hypoxemia, or respiratory depression from anesthesia induction to endoscope withdrawal. Analyses followed the intention-to-treat principle. Results Composite SRAEs occurred in 14 of 80 patients (17.5%) in the RE group and 28 of 80 patients (35.0%) in the PF group (RR, 0.50; 95% CI, 0.29-0.88; risk difference, -17.5 percentage points; 95% CI, -30.9 to -4.1; P=0.016). The adjusted RR was 0.49 (95% CI, 0.31-0.78; P=0.003). Anesthetic regimen success was similar between groups (97.5% vs 98.8%). Induction was modestly longer with RE, whereas eye-opening and modified Aldrete recovery time were slightly shorter. Conclusion In this selected population of older patients undergoing ERCP, the remimazolam-esketamine regimen was associated with fewer composite SRAEs than propofol-fentanyl while achieving a similar anesthetic regimen success rate. Induction was modestly longer. Tachycardia, hypertension, and psychotomimetic symptoms were numerically more frequent with RE, but event counts were small and estimates were imprecise. Multicenter studies are required to confirm generalizability.