Clinical Studie

Remimazolam for procedural sedation: a protocol for systematic review with meta-analysis, Trial Sequential Analysis, and GRADE

  • Research area: Clinical anaesthesia

  • Primary investigator: Lasse Stehr-Pingel

Anaesthetic drugs such as midazolam, which remimazolam is derived from, is frequently used in sedation procedures. Benzodiazepine (BDZ)s half-life has been reported to be between 1.8 to 6.4 hours, giving rise to a potentially unpredictable recovery. Another frequently used drug in anaesthesia is propofol and is known for its fast onset time and, in contrast to BDZs, rapid recovery. However, propofol can have less then desirable effects from both the patients and the anaesthesiologist perspective. It can give injection site pain and hypotension. This can lead to hemodynamic instability and hypotension. Respiratory depression associated with dosages is also a known adverse effect.

Remimazolam has been shown to have several benefits; among them is a mild circulatory depressive effect, and metabolism that is independent of kidney and liver function. Using suitable doses remimazolam’s plasma concentration rapidly declines in a predictable manner and the sedative effect is not prolonged.

The review aims to assess the beneficial and harmful effects of remimazolam versus placebo or other sedative agents in adult patients undergoing sedation. We will follow the methodology as outlined in the Cochrane Handbook, use Trial Sequential Analysis to account for the risks of random errors, Risk of Bias 2 to assess the risks of systematic errors, and we will assess the certainty of the evidence using GRADE. We will report the results according to the PRISMA-P guidelines.