Efficacy and Safety of Remimazolam Tosilate Combined with Propofol in Digestive Endoscopy: A Randomised Trial

Abstract

Current Knowledge and Objective. Remimazolam tosilate is a novel intravenous sedative of benzodiazepines with no tissue accumulation, which offers a faster onset of action and recovery time than midazolam. The aim of this trial was to compare the efficacy and safety of remimazolam (RM) combined with propofol and traditional propofol in painless digestive endoscopy with painless gastroscopy and colonoscopy. Methods. Patients were randomised into three groups: RM combined with propofol (RMP group, n = 35), RM (RM group, n = 40), and propofol (P group, n = 38). Each group received 0.1 μg/kg sufentanyl analgesia. An induction dose of 0.1 mg/kg RM and 1 mg/kg propofol was administered to the RMP group, 0.3 mg/kg RM to the RM group, and 2 mg/kg propofol to the P group. Per 5 min, the RMP and RM groups received an additional dose of 0.05 mg/kg RM, while the P group received an extra 0.5 mg/kg propofol. The comparisons involved induction regimen success rate, incidence of hypotension, low pulse rate, injection pain, grade of low oxygen saturation (SpO2), and postoperative adverse reactions. Results and Discussion. The RMP and P groups’ composition powers were 100%, and the RM group’s composition power was 95% ( $P=0.113$ ). The incidence rates of hypotension were 40.0%, 18.4%, and 44.7% in the RMP, RM, and P groups, respectively ( $P=0.037$ ). The low pulse incidence rates were 5.7%, 2.6%, and 5.3% in the RMP, RM, and P groups, respectively ( $P=0.771$ ). The incidence rates of injection pain were 11.4%, 2.6%, and 26.3% in the RMP, RM, and P groups, respectively ( $P=0.007$ ). There was no significant difference in low SpO2 severity scores ( $P=0.148$ ). New Findings and Conclusion. Remimazolam tosilate combined with propofol can be used for painless endoscopy, with almost the same safety as propofol. Remimazolam tosilate produces a low incidence of adverse reactions and is a safe anaesthetic option for painless endoscopies.