Effect of Remimazolam vs Propofol in High-Risk Patients Undergoing Upper Gastrointestinal Endoscopy: A Non-Inferiority Randomized Controlled Trial

Abstract

Abstract Background Procedural sedation is essential for optimizing upper gastrointestinal endoscopy, particularly in high-risk patients with multiple underlying diseases. Respiratory and circulatory complications present significant challenges for procedural sedation in this population. This non-inferiority randomized controlled trial aims to investigate the safety and comfort of remimazolam compared to propofol for procedural sedation during upper gastrointestinal endoscopy in high-risk patients. Methods A total of 576 high-risk patients scheduled to undergo upper gastrointestinal endoscopy were enrolled in this study and randomly allocated to either the remimazolam or propofol group. The primary outcome measure is a composite endpoint, which includes (1) achieving a Modified Observer's Alertness/Sedation scale(MOAA/S) score ≤ 3 before endoscope insertion; (2) successful completion of the endoscopic procedure; (3) absence of significant respiratory instability during the endoscopy and treatment; and (4) absence of significant circulatory instability during the examination. The noninferiority margin was 10%. Any adverse events (AEs) that occur will be reported. Discussion This trial aims to determine whether remimazolam is non-inferior to propofol for procedural sedation during upper gastrointestinal endoscopy in high-risk patients, with regard to success rate, complication incidence, patient comfort, and satisfaction. Trial registration : Chinese Clinical Trial Registry (http://www.chictr.org.cn), ChiCTR2200066527. Registered on 7 December 2022.