Efficacy and safety of remimazolam in procedural sedation and analgesia: A protocol for systematic review and meta analysis.

BACKGROUND

Remimazolam is a newly developed benzodiazepine as an alternative of conventional sedatives in the procedure of anesthesia. For the purpose of evaluating the efficacy and safety of remimazolam sedation during an endoscopy, we will perform a systematic review and meta-analysis of randomized controlled trials that compared remimazolam with midazolam and/or placebo.

METHODS

We will search PubMed, Embase, Web of Science, and the Cochrane Controlled Register of Trials (CENTRAL) from inception to December 2019 for randomized controlled trials that investigated efficacy and safety of remimazolam during an endoscopy. The job will be performed without language restriction. Experimental groups will include the interventions of remimazolam, while control groups will involve midazolam, placebo, or no controls. The primary outcome will be the onset time, followed by the secondary outcomes of the recovery time, the incidence of hypotension, the incidence of hypoxia and the incidence of bradycardia. Relative ratio or standardized mean difference will be used to measure the effect size of remimazolam. We will use I statistics to assess the between-study heterogeneity in each meta-analysis, Eager's test to detect publication bias.

RESULTS

The results of this study will be published in a peer-reviewed journal.

ETHICS AND DISSEMINATION

There is no need for ethical approval because all data used in this meta-analysis have been published. In addition, all data will be analyzed anonymously during the review process.

PROTOCOL REGISTRATION NUMBER

CRD42020170745.