Comparative safety and efficacy of remimazolam versus propofol for endoscopic retrograde cholangiopancreatography with the patient under deep sedation: a multicenter randomized controlled trial

Abstract

Background and Aims: ERCP requires the patient remain in deep sedation, which is most commonly achieved with propofol. Despite its efficacy, however, propofol is associated with adverse events such as hypoxemia and hypotension. Remimazolam, a short-acting benzodiazepine, has emerged as a potentially safer alternative. This multicenter randomized controlled trial aimed to compare the safety and efficacy of remimazolam versus propofol for deep sedation during ERCP. Methods: A total of 396 patients undergoing ERCP were randomized into the remimazolam (n = 198) or propofol (n = 198) group. The primary endpoint was sedation quality assessed by patient and endoscopist satisfaction. Secondary outcomes included procedural efficacy, incidence of adverse events, and safety parameters. Results: Sedation efficacy was comparable between the groups, with no significant differences in procedural or recovery times. However, patient satisfaction was significantly greater with remimazolam (9.00 [7.00-10.00]) than propofol (8.00 [6.00-10.00]; P = .024). Remimazolam significantly reduced both injection-site pain (19.7% vs 31.3%; P = .008) and moderate-to-severe cardiopulmonary events excluding hypoxemia (1.01% vs 4.54%; = .032). Multivariable analysis identified propofol (risk ratio [RR], 7.47; P = .018), low body mass index (RR, 1.23; P = .028), cardiovascular disease (RR, 6.44; P = .044), and alcohol intake (RR, 7.57; P = .011) as significant risk factors for cardiopulmonary adverse events. Conclusions: Remimazolam is a safe and effective alternative to propofol for sedation during ERCP, demonstrating comparable sedation efficacy, greater patient satisfaction, reduced injection-site pain, and fewer moderate-to-severe cardiopulmonary adverse events. Remimazolam thus has strong clinical utility, particularly patients at a greater risk of sedation-related adverse events. (Gastrointest Endosc 2026;103:1192-200.)