Effectiveness and safety of remimazolam tosilate versus propofol for sedation in patients undergoing gastrointestinal endoscopy: a randomized controlled trial

Abstract Background Remimazolam tosilate and propofol are commonly used sedatives. However, there are few reports that compare the effectiveness and safety of remimazolam with those of propofol combined with alfentanil. Aim This trial compared the effectiveness and safety of remimazolam with those of propofol in patients undergoing painless gastrointestinal endoscopy. Methods One hundred and sixty-six eligible patients who underwent painless gastrointestinal endoscopy under intravenous anaesthesia were randomly divided into 2 groups: the propofol control group (Group P) and the remimazolam group (Group R). The primary outcomes were perioperative haemodynamic variables. The secondary outcomes included induction and awakening time, patient satisfaction, operator satisfaction, drug injection pain, hypoxemia, hypotension, bradycardia, limb movement, hiccups, postoperative nausea and vomiting, and 4 times or more drug additions. Results Compared with those in Group P, the SBP in Group R was significantly higher at T1, T2, T3, and T6 (P < 0.05); the DBP and MAP were significantly higher at T1, T2, T3, T5, and T6 (P < 0.05); the HR was significantly faster at T1 to T6 (P < 0.05); the SpO2 was significantly higher at T1 to T4 (P < 0.05); the incidences of intraoperative hypoxemia, hypotension, and drug injection pain were significantly lower in Group R (P < 0.05); the incidence of intraoperative hiccups was higher (P < 0.05); the awakening time was shorter in Group R (P < 0.05); and the operator satisfaction score was high (P < 0.05). Conclusions Remimazolam, in combination with alfentanil, is utilized for painless gastrointestinal endoscopy,which has a short awakening time, minimal circulatory and respiratory effects, and low incidence of adverse events. Clinical trial registration This trial protocol was registered in the Chinese Clinical Trial Registry (ChiCR2300077252, date: 2023 11 02)