Efficacy and Safety of Different Doses of Remimazolam Tosilate Applied in Upper Gastrointestinal Endoscopy: A Prospective Randomized Controlled Double-Blind Trial.

BACKGROUND: Remimazolam is a novel benzodiazepine narcotic. When used for gastrointestinal endoscopy or bronchoscopy, it provides adequate sedation and rapid recovery. However, studies on the optimal initial loading dose of remimazolam remain inadequate. Therefore, we conducted a randomized controlled clinical trial to investigate the efficacy and safety of different doses of remimazolam applied in upper gastrointestinal endoscopy.

METHODS: A total of 218 patients scheduled for upper gastrointestinal endoscopy were included in our trial and divided into experimental and control groups: the experimental groups were the remimazolam groups (R1 of 0.2 mg/kg, R2 of 0.3 mg/kg, and R3 of 0.4 mg/kg), and the control group was the propofol group. Following a single injection of trial drugs during the induction period, operational requirements were evaluated based on MOAA/S scores. When the sedation was successfully achieved, safety was evaluated based on the incidence of various intraoperative and postoperative adverse events.

RESULTS: The success rates of intraoperative sedation were 82% in group R1, 98% in group R2, 96% in group R3, and 100% in group P. The incidence of hypotension was lower in the remimazolam groups than in the propofol group (16%), 4% in group R1, 6% in group R2, and 6% in group R3. The incidence of postoperative vertigo was significantly higher, and sedation recovery time was prolonged in high-concentration remimazolam group.

CONCLUSION: Satisfactory efficacy can be obtained with higher concentrations of remimazolam tosilate in patients undergoing upper gastrointestinal endoscopy with ASA grade I or II. However, as the dose is progressively increased, the incidence of adverse reactions by remimazolam tosilate are also significantly increased, such as vertigo and prolonged sedation recovery time.

TRIAL REGISTRATION: The trial was registered prior to enrollment at the Chinese Clinical Trial Registry (ChiCTR 2000032067).