Introduction:
Deep sedation is essential for successful endoscopic retrograde cholangiopancreatography (ERCP), a technically complex procedure frequently performed in elderly patients and those with significant comorbidities. Propofol remains the most commonly used sedative agent because of its rapid onset and effectiveness; however, cardiopulmonary adverse events such as hypotension and respiratory instability remain important limitations.
Problem Statement:
As the complexity and volume of therapeutic endoscopic procedures continue to increase, safer sedation strategies are needed. Remimazolam, an ultra-short-acting benzodiazepine with rapid recovery, predictable metabolism, and the availability of reversal with flumazenil, has emerged as a promising alternative. However, prospective randomized evidence supporting its use specifically during ERCP has been limited.
Summary:
This multicenter randomized controlled trial compared remimazolam with propofol for deep sedation during ERCP. The study demonstrated that remimazolam provided effective procedural sedation while maintaining procedural success and high operator satisfaction. Importantly, remimazolam was associated with a lower incidence of cardiopulmonary adverse events compared with propofol, highlighting a potential safety advantage in a population often characterized by advanced age and multiple medical comorbidities. Despite its improved safety profile, remimazolam maintained adequate sedation quality and did not compromise procedural performance. These findings are particularly relevant for advanced therapeutic endoscopy, where prolonged and stable sedation is required while minimizing hemodynamic and respiratory complications. The pharmacologic characteristics of remimazolam, including rapid onset, short duration of action, organ-independent metabolism, and reversibility with flumazenil, further support its suitability for use outside the operating room environment. As one of the largest prospective randomized studies evaluating remimazolam specifically in the ERCP setting, this trial provides important real-world evidence supporting its clinical adoption. Overall, the results suggest that remimazolam may represent a safer alternative to propofol for deep sedation during ERCP, especially in patients at increased risk for sedation-related complications. Future studies should further define optimal dosing strategies, cost-effectiveness, and outcomes in higher-risk patient populations.