Efficacy and safety of remimazolam for sedation during gynaecologic procedures: a systematic review and meta-analysis.

INTRODUCTION

The efficacy of remimazolam compared to propofol for sedation during gynaecologic procedures remains unknown, due to the increased severity of pain associated with these procedures. Therefore, a systematic review and meta-analysis was conducted to address this issue.

MATERIALS AND

METHODS

The protocol has been registered with PROSPERO, number CRD42024511475. Medline/PubMed, Cochrane Library, Embase, Scopus and Web of Science were searched to identify randomized controlled trials (RCTs) covering the period up to 10 January 2025. The primary outcomes comprised the success rate of sedation and the incidence of body movement. Secondary outcomes included recovery time and incidence of adverse effects (i.e. hypotension, bradycardia, respiratory depression, postoperative nausea and vomiting (PONV), dizziness, hiccup and injection pain).

RESULTS

Nine RCTs (1129 patients) were included in this meta-analysis. There were no significant differences for the success rate of sedation (RR = 0.98, 95% confidence interval (CI) 0.96-1.00) or the incidence of body movement (RR = 1.03, 95% CI 0.49-2.14). Remimazolam had a lower incidence of adverse effects, including hypotension (RR = 0.21, 95% CI 0.11-0.41), bradycardia (RR = 0.12, 95% CI 0.02-0.97), respiratory depression (RR = 0.30, 95% CI 0.15-0.61), injection pain (RR = 0.06, 95% CI 0.02-0.17) and dizziness (RR = 0.29, 95% CI 0.10-0.82). However, remimazolam increased the incidence of hiccup (RR = 10.16, 95% CI 2.48-41.61). No significant differences were found regarding the recovery time (MD = 1.58, 95% CI -0.20 to 3.35) or the incidence of PONV (RR = 0.68, 95% CI 0.15-3.05).

CONCLUSIONS

In gynaecologic procedures, remimazolam has comparable efficacy to propofol in the success rate of sedation and the incidence of body movement, while exhibiting superior respiratory and cardiovascular safety profiles. These findings should be cautiously generalized to other populations, and warrant further validation.