Comparison of remimazolam and propofol about safety outcome indicators during general anesthesia in surgical patients: a systematic review and meta-analysis.

INTRODUCTION: Remimazolam is a novel sedative drug that has been successively approved for procedural sedation and general anesthesia, however, which has not been fully explored due to limited clinical studies and a small sample size. Current clinical studies have focused on the use of remimazolam and propofol for general anesthesia (GA) as indicators of safety outcomes in surgical patients, but different studies have reached different conclusions. The aim of this study was to investigate whether the safety-related outcome indicators in GA were superior to propofol in surgical patients.

EVIDENCE ACQUISITION: We systematically searched PubMed, Cochrane Library, Embase, and Web of Science databases for all published randomized controlled trials comparing remimazolam with propofol for general anesthesia. Data from eligible studies were pooled with relative risk or mean differences to analyze the differences in hemodynamic stability and adverse effects of the two medications.

EVIDENCE SYNTHESIS: Eight randomized controlled trials involving 998 participants were included. Compared with propofol, remimazolam had better hemodynamic stability with a lower incidence of hypotension (RR=0.43, 95% CI: [0.34, 0.55], I2 =0%, P<0.00001), a higher preintubation, and immediate postintubation mean arterial pressure (MAP, MD=5.41, 95% CI: [5.26,11.24], Z=5.41, P<0.00001<0.05); (MD=1.60, 95% CI: [-0.20, 3.41], Z=1.74, P<0.08>0.05). Regarding other adverse events, the incidence of hypoxemia, nausea and vomiting, dizziness and injection site pain was lower in the remimazolam group compared to the propofol group.

CONCLUSIONS: In this Meta-analysis, compared with propofol, remimazolam for GA reduced the incidence of hypotension, hypoxemia, nausea and vomiting, dizziness and injection site pain, and had a more stable MAP before and after intubation, which supported that remimazolam is a safer sedative. However, a large sample is needed to validate this finding.