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Safety and Efficacy of Remimazolam Compared With Placebo and Midazolam for Moderate Sedation During Bronchoscopy.
- Source :
-
Chest [Chest] 2019 Jan; Vol. 155 (1), pp. 137-146. Date of Electronic Publication: 2018 Oct 04. - Publication Year :
- 2019
-
Abstract
- Background: While the complexity of flexible bronchoscopy has increased, standard options for moderate sedation medications have not changed in three decades. There is a need to improve moderate sedation while maintaining safety. Remimazolam was developed to address shortcomings of current sedation strategies.<br />Methods: A prospective, double-blind, randomized, multicenter, parallel group trial was performed at 30 US sites. The efficacy and safety of remimazolam for sedation during flexible bronchoscopy were compared with placebo and open-label midazolam.<br />Results: The success rates were 80.6% in the remimazolam arm, 4.8% in the placebo arm (P < .0001), and 32.9% in the midazolam arm. Bronchoscopy was started sooner in the remimazolam arm (mean, 6.4 ± 5.82 min) compared with placebo (17.2 ± 4.15 min; P < .0001) and midazolam (16.3 ± 8.60 min). Time to full alertness after the end of bronchoscopy was significantly shorter in patients treated with remimazolam (median, 6.0 min; 95% CI, 5.2-7.1) compared with those treated with placebo (13.6 min; 95% CI, 8.1-24.0; P = .0001) and midazolam (12.0 min; 95% CI, 5.0-15.0). Remimazolam registered superior restoration of neuropsychiatric function compared with placebo and midazolam. Safety was comparable among all three arms, and 5.6% of the patients in the remimazolam group had serious treatment-emergent adverse events as compared with 6.8% in the placebo group.<br />Conclusions: Remimazolam administered under the supervision of a pulmonologist was effective and safe for moderate sedation during flexible bronchoscopy. In an exploratory analysis, it demonstrated a shorter onset of action and faster neuropsychiatric recovery than midazolam.<br /> (Copyright © 2018 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Adult
Aged
Aged, 80 and over
Dose-Response Relationship, Drug
Double-Blind Method
Female
Humans
Hypnotics and Sedatives administration & dosage
Infusions, Intravenous
Male
Middle Aged
Prospective Studies
Young Adult
Benzodiazepines administration & dosage
Bronchoscopy methods
Conscious Sedation methods
Midazolam administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1931-3543
- Volume :
- 155
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Chest
- Publication Type :
- Academic Journal
- Accession number :
- 30292760
- Full Text :
- https://doi.org/10.1016/j.chest.2018.09.015