Safety and efficacy of remimazolam besylate in patients undergoing colonoscopy: A multicentre, single-blind, randomized, controlled, phase Ⅲ trial

Abstract

Study objective: The objective of the study was to evaluate the safety and efficacy of remimazolam besylate versus propofol injection in patients undergoing colonoscopy.Design: A multicenter, randomized, non-inferiority, single-blind, parallel-controlled clinical trial.Setting: Operating room.Patients: Patients aged 18–65 years (American Society of Anesthesiologists [ASA] classification I-III) undergoing a diagnostic or therapeutic colonoscopy.Interventions: Patients were administered intravenous injection of remimazolam besylate or propofol (active comparator) for sedation.Measurements: Modified Observer’s Assessment of Alertness/Sedation [MOAA/S] scores of the included patients were assessed before dosing, 1, 1.5, 2, 2.5, and 3 min after the start of dosing, and then every 1 min until the MOAA/S score reached 5 on three consecutive occasions.Main Results: A total of 360 patients received remimazolam and 120 patients received propofol. The incidence of adverse events (67.8% vs. 84.2%, p = 0.001) was significantly lower in patients administered remimazolam compared to propofol. There was no significant difference in sedation success rates (full analysis set [FAS]: 98.9% vs. 99.2%; remimazolam vs. propofol). Remimazolam had a significantly longer onset of action, but the difference was not considered clinically significant (1.45 min vs. 1.24 min, remimazolam vs. propofol). Propofol achieved a deeper level of sedation (mean MOAA/S score 0.5 vs. 0.2; remimazolam vs. propofol). Mean time to discharge after the end of the last administration of study drug (20.3 vs. 21.8 min, p = 0.020) and incidence of injection pain was significantly lower in patients administered remimazolam (2.3% vs. 35.3%, p < 0.0001). Incidence of oxygen desaturation was significantly higher in patients administered propofol compared to patients administered remimazolam (6.7% vs. 1.1%, p = 0.001). Similarly, incidence of hypotension was more frequent in patients administered propofol compared to patients administered remimazolam (29.2% vs. 10.6%, p < 0.0001).Conclusion: Remimazolam besylate had a better safety and tolerability profile and similar sedative efficacy to propofol in patients undergoing a diagnostic or therapeutic colonoscopy in China, suggesting that remimazolam besylate has potential as a sedative agent for colonoscopy.

Effectiveness and safety of remimazolam tosilate versus propofol in patients undergoing painless gastrointestinal endoscopy: A randomized controlled trial.

“…Benzodiazepine is an anaesthetic that metabolizes quickly and does accumulate due to increased dosage or prolonged infusion time. Therefore, they can stabilize haemodynamics while providing rapid anaesthesia and having a slight inhibitory effect on breathing [17]. The HR of patients in Group R increased slightly after the administration of RT.…”

ED50 of remimazolam combined with different doses butorphanol for first trimester artificial abortion

“…However, RMZ may be a safer sedative during anesthetic induction than propofol ( 9 , 19 ). Many studies demonstrated that RMZ may reduce the incidence of hypotension, hypoxemia and injection-site pain compared to propofol, which is its most pronounced feature and advantage ( 7 , 18 , 20 ). Our findings revealed that the reduction of MAP in both groups was about 11%.…”

Efficacy and safety of remimazolam besilate for sedation in outpatients undergoing impacted third molar extraction: a prospective exploratory study

“…Several recent randomized controlled trials have compared remimazolam to propofol in procedural sedation such as gastric endoscopy and hysteroscopy. These studies have consistently demonstrated that the incidence of adverse events was significantly lower in patients administered remimazolam compared to propofol [ 29 – 31 ]. The time to loss of consciousness in the remimazolam group was longer compared to the propofol group [ 29 ].…”