Efficacy and safety of remimazolam besylate versus propofol during hysteroscopy: single-centre randomized controlled trial

Abstract

Background Remimazolam besylate is a newer benzodiazepine with characteristics of quick onset of effects, short maintenance and recovery times without accumulation in tissues. This trial was conducted to confirm the efficacy and safety of remimazolam besylate versus propofol during hysteroscopy. Methods Patients undergoing hysteroscopy were randomly assigned to either the remimazolam (Group R) or the propofol group (Group P). Group R was administered an induction dose of 0.2 mg/kg and a maintenance dosage of 1.0 mg/kg/h. In Group P, propofol was started at 1.5–2.0 mg/kg and then maintained at 3.0–6.0 mg/kg/h. After remimazolam besylate or propofol induction, remifentanil was infused using a target-controlled infusion system with a target concentration of 1.5 ng/ml and titrated during the procedure. The incidence rates of injection pain, low oxygen saturation (SpO2) and adverse effects in both groups were compared. Results Eighty-two patients were included in this study. The incidence of adverse events in Group R (3.7%) was significantly lower than that in Group P (36.6%) (p < 0.001). The incidence of injection pain in Group P (80.5%) was much higher than that in Group R (2.4%) (p < 0.001). The incidence of other adverse events, such as low SpO2, bradycardia, and hypotension in Group R was lower than that in Group P (p < 0.05). Conclusions Remimazolam besylate proves to be a safer alternative for anesthesia during hysteroscopy. Moreover, adverse events caused by propofol, such as low SpO2 and injection pain, are largely avoided. Trial registration This study was approved by the Clinical Research Ethics Committee of Mengcheng County No. 1 People’s Hospital (2020MYL20003) and registered at http://www.chictr.org.cn (15/09/2020, ChiCTR-2000038252). The study protocol followed the CONSORT guidelines. The study protocol was performed in the relevant guidelines.

Efficacy and Safety of Remimazolam for Procedural Sedation: A Meta-Analysis of Randomized Controlled Trials With Trial Sequential Analysis

“…Remimazolam has been approved on 23 January 2020 in Japan for use in general anesthesia and on 5 July 2020 in the United States for procedural sedation ( 35 ). For procedural sedation, RCTs have only compared remimazolam with midazolam as abovementioned studies or propofol ( 36 , 37 ). To determine the beneficial evidence of remimazolam compared to current standard regiments, more large-scale RCTs are warranted.…”

Effect of remimazolam besylate compared with propofol on the incidence of delirium after cardiac surgery: study protocol for a randomized trial

“…The current study will be the largest prospective randomized clinical trial evaluating the possibility of using remimazolam besylate-based operative sedation to reduce delirium in patients after cardiac surgery compared with propofol. Although several recent studies have compared the safety and sedation efficacy of remimazolam and propofol [ 25 – 27 ], none of them have focused specifically on delirium. Propofol use has been associated with delirium in some, but not all, clinical studies [ 15 ].…”

Efficacy and Safety Profile of Remimazolam for Sedation in Adults Undergoing Short Surgical Procedures

“…Zhang et al compared the effects of remimazolam vs propofol administration in patients who underwent hysteroscopy. 9 Remimazolam was administered at a dose of 0.2 mg/kg and maintained at a dose of 1 mg/kg/hour. Propofol was administered at 1.5-2 mg/kg and maintained at 3-6 mg/kg/hour.…”