The safety and efficacy of remimazolam tosylate combined with propofol in upper gastrointestinal endoscopy: a multicenter, randomized clinical trial

Introduction Hypotension is the most common adverse event under propofol-mediated sedation and is possible to cause varying degrees of damage to patients. Whereas remimazolam has a poorer sedative effect than propofol. Aim The aim of this study was to explore the advantages of the combination of remimazolam tosylate and propofol. Methods 304 patients were divided into the remimazolam tosylate group, the propofol group, and the remimazolam tosylate plus propofol group. The primary outcome was the incidence of hypotension. Secondary outcomes included the results of sedation and recovery. Results The incidence of hypotension was 56.7% in the P group, 12.6% in the RT group, and 31.3% in the R+P group, with P < 0.001. The incidence of body movement was significantly higher in the RT group (26.1%) than in the P group (10.3%) and the R+P group (12.5%), P =0.004. The endoscopist satisfaction was higher in the P (3.87±0.44) and R+P (3.95±0.22)groups than in the RT(3.53±0.84) group. The incidence of adverse events, in descending order, was P group, RT group, and R+P group (93.8%vs.61.3%vs.42.7%). Conclusion Co-administration had fewer adverse events than propofol monotherapy, also had a better sedative effect and higher endoscopist satisfaction than remimazolam monotherapy. Clinical trial registration number NCT05429086