Remimazolam versus sevoflurane for general anaesthesia: A meta-analysis with trial sequential analysis of haemodynamic and clinical outcomes.

BACKGROUND

Remimazolam is a novel ultra-short-acting intravenous benzodiazepine, while sevoflurane is a widely used inhalational anaesthetic for general anaesthesia (GA). Both agents are associated with risks of haemodynamic instability and postoperative nausea and vomiting (PONV), which can affect patient safety and recovery.

OBJECTIVE

To compare the efficacy and safety of remimazolam versus sevoflurane in terms of intraoperative haemodynamic stability during the maintenance phase of GA or deep sedation, and the incidence of PONV.

DESIGN

Systematic review of randomised controlled trials (RCTs) and meta-analysis, with trial sequential analysis (TSA).

DATA SOURCES: PubMed/MEDLINE, Embase, Cochrane CENTRAL, Web of Science and Scopus were systematically searched from inception to April 2025.

ELIGIBILITY CRITERIA: RCTs comparing intraoperative use of remimazolam and sevoflurane with reported intraoperative or postoperative outcomes. Conference abstracts were excluded.

RESULTS

Twelve RCTs (n = 739 patients; mean age 61.6 years; 36.8% laparoscopic procedures) were included. Remimazolam significantly reduced the risk of intraoperative hypotension (as a binary event) compared with sevoflurane [risk ratio (RR) 0.38, 95% confidence interval (CI) 0.25 to 0.57; P < 0.001]. Mean arterial pressure (MAP) was higher with remimazolam at 30 min after start of surgery (mean difference 6.05 mmHg, P < 0.03). Heart rate (HR) was consistently higher with remimazolam at 30 min (P = 0.04), at the end of surgery (P < 0.01) and in the postanaesthesia care unit (P < 0.01). Analyses suggested a reduction in PONV incidence up to 24 h with remimazolam [RR 0.65 (95% CI, 0.47 to 0.90); P = 0.01] and 72 h [RR 0.66 (95% CI, 0.50 to 0.89)]. TSA just confirmed favouring remimazolam in reducing intraoperative hypotension.

CONCLUSIONS

Remimazolam was associated with a lower incidence of intraoperative hypotension compared with sevoflurane, while differences in MAP and HR were limited to specific time points. Sensitivity analyses suggested a potential reduction in PONV; however, these findings were not statistically significant in the primary analysis and should be interpreted with caution.