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Randomized Controlled Trial of Remimazolam Compared with Placebo in Japanese Patients Undergoing Colonoscopy: A Phase III, Investigator-Initiated Trial.
- Source :
-
Digestion [Digestion] 2024 Jul 26, pp. 1-9. Date of Electronic Publication: 2024 Jul 26. - Publication Year :
- 2024
- Publisher :
- Ahead of Print
-
Abstract
- Introduction: We conducted an investigator-initiated clinical trial in which remimazolam was used to achieve sedation in patients undergoing colonoscopies.<br />Methods: This multicenter, double-blind, placebo-controlled, phase III investigator-initiated trial included patients who underwent colonoscopy under sedation with remimazolam (initial dose: 3 mg; additional dose: 1 mg) or normal saline (placebo). The primary endpoint of the study was the successful sedation rate during colonoscopy, defined as achieving a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score of ≤4 before the procedure, maintaining this score throughout colonoscopy, and requiring no more than five additional drug doses per 15 min.<br />Results: The sedation success rate was 95.0% (38/40 patients) in the remimazolam group and 0.0% (0/11 patients) in the placebo group (p &lt; 0.01). The time from the end of procedure to regaining consciousness was 0.0 (interquartile range: 0.0-0.0) min in both groups. The time from the end of the procedure to ambulation was 5.0 (interquartile range: 0.0-10.0) min in the remimazolam group and 0.0 (interquartile range: 0.0-0.0) min in the placebo group (p = 0.02). Serious adverse events were not observed.<br />Conclusion: The use of remimazolam to achieve sedation in Japanese patients undergoing colonoscopy was more effective than placebo.<br /> (© 2024 The Author(s). Published by S. Karger AG, Basel.)
Details
- Language :
- English
- ISSN :
- 1421-9867
- Database :
- MEDLINE
- Journal :
- Digestion
- Publication Type :
- Academic Journal
- Accession number :
- 39068917
- Full Text :
- https://doi.org/10.1159/000540527