drugset / Trial / NCT05836545
Remimazolam Versus Midaszolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy
RandomizedParallel-groupSingle-blindDiagnostic
Summary
The goal of this clinical trial is to compare the efficacy of remimazolam with midazolam in patients undergoing gastrointestinal endoscopy. The main questions it aims to answer are: * Superiority of total procedure time in remimazolam compared to midazolam * The success of sedation time This is the single blind study.; Patients will not know what they are given as the sedation drug If there is a comparison group: Researchers will compare patients with midazolam group to see if remimazolam group is superior to midazolam group
Timeline
- Start
- 2023-04-05
- Primary completion
- 2024-01-06
- Completion
- 2024-01-06
Outcome
Met primary endpoint
paper The total procedure time was significantly shorter in the remimazolam group (30.3 vs. 48.5 min, p < 0.001). PMID 41284133 ↗
Publications
- Ahn DW, Lee JK, Lee KH, Kim T, Kang SH, Park Y, Kim SB, Kim SJ. Remimazolam versus midazolam for sedation in diagnostic upper gastrointestinal endoscopy: study protocol for a randomized controlled trial. Trials. 2026 Apr 11;27(1):376. doi: 10.1186/s13063-026-09712-5.
- Park Y, Lee JK, Lee KH, Kim T, Kang SH, Ahn DW, Kim SB, Kim SJ. Remimazolam Enables Faster Sedation Induction and Recovery Compared With Midazolam in Diagnostic Upper Gastrointestinal Endoscopy: A Multicenter Randomized Controlled Trial. United European Gastroenterol J. 2026 Feb;14(1):e70147. doi: 10.1002/ueg2.70147. Epub 2025 Nov 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Midazolam | Small molecule | 1 mg | — |
| Comparator | Midazolam | Small molecule | 2 mg | — |
| Subject | Remimazolam | Small molecule | 2.5 mg | — |
Indications
No indication recorded.