Introduction: Remimazolam is a novel and ultra-short-acting benzodiazepine currently approved for procedural sedation and induction of general anaesthesia, with a possible indication for ICU sedation. This study aimed to evaluate the efficacy and safety of remimazolam and traditional sedatives for patients undergoing procedural sedation.
Evidence acquisition: We systematically searched Cochrane Library, Embase, PubMed, Web of Science and ClinicalTrials.gov for randomized controlled trials of procedural sedation performed with remimazolam versus traditional sedatives. Data from the eligible studies were combined to calculate pooled risk ratio or standardized mean difference.
Evidence synthesis: Eleven studies of 2356 patients met the inclusion criteria. The results showed that remimazolam was associated with a higher procedure success rate (RR: 1.28, 95% CI: 1.07 to 1.52, P=0.006; I2=99%), a shorter duration of recovery after procedure (SMD: -0.56, 95% CI: -0.98, -0.14, P=0.009; I2=89%), and an earlier patient discharge after procedure (SMD: -0.37, 95% CI: -0.49, -0.25, P<0.00001; I2=0%) in comparison with traditional sedatives. There were no statistically significant differences in onset time, procedure time, and cognitive recovery between remimazolam and traditional sedatives groups. Remimazolam significantly decreased the rate of bradycardia (RR: 0.65, 95% CI: 0.43, 0.97, P=0.04; I2=0%), hypotension (RR: 0.57, 95% CI: 0.40, 0.80, P=0.001; I2=80%), and respiratory depression/hypoxia (RR: 0.46, 95% CI: 0.25, 0.83, P=0.01; I2=61%) compared to traditional sedatives.
Conclusions: Remimazolam is a safe and effective sedative for procedural sedation on account of a higher success procedure rate, a faster recovery, a shorter discharge time, and a superior safety profile in comparison with traditional sedatives. Larger sample-sized and well-designed clinical trials are needed to verify our finding.