AUTHOR=Jhuang Bo-Jyun , Yeh Bo-Han , Huang Yen-Ta , Lai Pei-Chun 

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

JOURNAL=Frontiers in Medicine

VOLUME=8

YEAR=2021

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2021.641866

DOI=10.3389/fmed.2021.641866

ISSN=2296-858X

ABSTRACT=<p><bold>Background:</bold> Remimazolam is a new ultrashort-acting benzodiazepine. Remimazolam has been approved for procedural sedation by the US Food and Drug Administration in 2020. However, prior trials and the participants they enrolled were limited.</p><p><bold>Aim:</bold> In this meta-analysis, we investigated the effectiveness and adverse events (AEs) of remimazolam during procedural sedation.</p><p><bold>Materials and Methods:</bold> The study protocol was registered (doi: <ext-link ext-link-type="uri" xlink:href="https://doi.org/10.37766/inplasy2020.8.0043" xmlns:xlink="http://www.w3.org/1999/xlink">10.37766/inplasy2020.8.0043</ext-link>), and six databases were searched. We performed meta-analysis, trial sequential analysis (TSA), and Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology for judging the certainty of evidence (CoE).</p><p><bold>Results:</bold> A total of five randomized controlled trials with 1,248 participants were included. Compared with the use of midazolam, the utilization of remimazolam resulted in an increase in procedure success rate [odds ratio (OR) = 9.01, 95% confidence interval (CI): 2.35–34.57], a reduction in the application of rescue medication (OR = 13.58, 95% CI: 3.46–53.28), a decrease in time to recovery [minutes, weighted mean difference (WMD) = −5.70, 95% CI: −8.68 to −2.72], and a better cognitive recovery of Hopkins Verbal Learning Test-Revised (WMD = 5.22, 95% CI: 2.88–7.55). No difference was found in completion of procedure (OR = 1.68, 95% CI: 0.72–3.90) with inconclusive in TSA. Despite no difference of total AEs (OR = 0.60, 95% CI: 0.24–1.50), more detailed analysis of AEs remained inconclusive in TSA. The GRADE assessment demonstrated low to very low CoE.</p><p><bold>Conclusion:</bold> Our analysis suggested that remimazolam may be a better choice for procedural sedation than midazolam. Nevertheless, further studies are warranted to conclusively establish its safety.</p>