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Review
. 2023 Nov;67(10):1432-1438.
doi: 10.1111/aas.14316. Epub 2023 Aug 14.

Remimazolam for sedation: A protocol for a systematic review with meta-analysis, trial sequential analysis, and GRADE approach

Lasse Stehr-Pingel  1 , Mathias Maagaard  1 , Casper Duevang Tvarnø  1 , Lars Peter Kloster Andersen  1 , Jakob Hessel Andersen  1 , Ole Mathiesen  1   2
Affiliations
Review

Remimazolam for sedation: A protocol for a systematic review with meta-analysis, trial sequential analysis, and GRADE approach

Lasse Stehr-Pingel et al. Acta Anaesthesiol Scand. 2023 Nov.

Abstract

Background: Procedural sedation aims to facilitate a successful diagnostic or therapeutic procedure. The pharmacokinetic properties and pharmacodynamic effects need to be taken into consideration when choosing the ideal sedative. Midazolam and propofol are frequently employed. However, they are associated with respiratory depression with increasing dosage. Also, midazolam has a potentially unpredictable pharmacodynamic response and propofol may cause hypotension and injection site pain. Remimazolam may provide a superior alternative due to its rapid pharmacodynamic profile and insignificant circulatory effects.

Methods: This protocol employs the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. The review aims to assess the beneficial and harmful clinical effects of remimazolam versus placebo or other sedatives in adult patients requiring sedation in relation to a diagnostic or therapeutic procedure, or due to other circumstances. Three primary outcomes are identified: Sedation success rate, respiratory complications, and hemodynamic complications. Six secondary outcomes are identified: among these are quality of recovery and serious adverse events. All randomized trials are included. The search strategy includes six major biomedical databases. Literature screening and data extraction will be performed independently by two authors. Risk of systemic error will be assessed with Risk of Bias 2 Tool. Risk of random error will be assessed with trial sequential analysis. Heterogeneity will be evaluated by appropriate statistical tests. The certainty of the evidence will be judged using Grading of Recommendations Assessment, Development, and Evaluation. Meta-analysis will be carried out with Rstudio. A "Summary of Findings" table will be presented with our primary and secondary outcome results.

Discussion: The systematic review with up-to-date methodology outlined in this protocol investigates the clinical effects of remimazolam in relation to procedural sedation. The results may guide clinicians in the clinical use of remimazolam.

Keywords: GRADE; meta-analysis; remimazolam; sedation; systematic review; trial sequential analysis.

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References

REFERENCES

    1. Krauss B, Green SM. Procedural sedation and analgesia in children. Lancet. 2006;367:766-780.
    1. Leroy PLJM, Schipper DM, Knape HTA. Professional skills and competence for safe and effective procedural sedation in children: recommendations based on a systematic review of the literature. Int J Pediatr. 2010;2010:934298.
    1. Practice guidelines for moderate procedural sedation and analgesia 2018: A report by the American Society of Anesthesiologists Task Force on moderate procedural sedation and analgesia, the American Association of Oral and Maxillofacial Surgeons, American College of Radiology, American dental association, American Society of Dentist Anesthesiologists, and Society of Interventional Radiology*. Anesthesiology. 2018(128):437-479. https://pubs.asahq.org/anesthesiology/article/128/3/437/18818/Practice-G...
    1. Hara T, Ozawa A, Shibutani K, et al. Working Group for the Preparation of practical guidelines for safe sedation SCotJSoA. Practical guide for safe sedation. J Anesth. 2023;37:340-356.
    1. Zhang L, Li C, Zhao C, You Y, Xu J. The comparison of remimazolam and midazolam for the sedation of gastrointestinal endoscopy: a meta-analysis of randomized controlled studies. Afr Health Sci. 2022;22:384-391.

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