Remimazolam for procedural sedation in gastrointestinal endoscopy: real-life, single center observational study
- PMID: 39881221
- PMCID: PMC11776136
- DOI: 10.1186/s12876-025-03636-1
Remimazolam for procedural sedation in gastrointestinal endoscopy: real-life, single center observational study
Abstract
Background and aim: Remimazolam has proved to be a very promising sedative drug in randomized clinical trials for usage in a wide spectrum of patients, including critically ill ones. The purpose of our study was to verify efficacy and safety of remimazolam for procedural sedation during diagnostic and first level operative endoscopy in a real-world setting.
Methods: This single centre prospective study evaluated sedation regimen with remimazolam for EGDS and fentanyl and remimazolam for colonoscopy in consecutive ASA 1-3 patients.
Results: Seventy-one patients underwent 73 procedures (25 EGDS, 48 colonoscopies) with a total amount of 13.2 ± 8.7 mg and 10.2 ± 6.2 mg of remimazolam administered respectively. In 6 EGDS, rescue sedation with propofol was needed. Transient hypotension was frequent (37%) and no cases of hypoxia occurred. One case of suspected allergy (erythema of the trunk) without anaphylaxis was reported.
Conclusions: Procedural sedation can be applied with remimazolam without the use of propofol, obtaining effective sedation in colonoscopies while in EGDS remimazolam alone guarantees the result in a percentage of around 70-75% of cases.
Keywords: Gastrointestinal endoscopy; Safety; Sedation.
© 2025. The Author(s).
Conflict of interest statement
Declarations. Ethics approval and consent to participate: This study was performed in accordance with the principles of the Declaration of Helsinki. the study was reviewed and approved in 2024, December 23th (protocol 432/2023/OSS*/AOUMO) by the Ethical Committee (Comitato Etico Area Vasta Emilia Nord, Modena, Italy). A signed informed consent was obtained for sedation before any clinical investigation. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.
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References
-
- Rogers WK, McDowell TS. Remimazolam, a short-acting GABA(A) receptor agonist for intravenous sedation and/or anesthesia in day-case surgical and non-surgical procedures. IDrugs. 2010;13:929–37. - PubMed
-
- Oka S, Satomi H, Sekino R, et al. Sedation outcomes for remimazolam, a new benzodiazepine. J Oral Sci. 2021;63:209–11. - PubMed
-
- Antonik LJ, Goldwater DR, Kilpatrick GJ, et al. A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): part I. safety, efficacy, and basic pharmacokinetics. Anesth Analg. 2012;115:274–83. - PubMed
-
- Rex DK, Bhandari R, Desta T, et al. A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy. Gastrointest Endosc. 2018;88:427–37. - PubMed
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