• Nicholas J Pastis, Lonny B Yarmus, Frank Schippers, Randall Ostroff, Alexander Chen, Jason Akulian, Momen Wahidi, Samira Shojaee, Nichole T Tanner, Sean P Callahan, Gregory Feldman, Daniel G Lorch, Ikeadi Ndukwu, Michael A Pritchett, Gerard A Silvestri, and PAION Investigators.
• Division of Pulmonary and Critical Care, Medical University of South Carolina, Charleston, SC. Electronic address: pastisn@musc.edu.
• Chest. 2019 Jan 1; 155 (1): 137-146.

BackgroundWhile 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.MethodsA 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.ResultsThe 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.ConclusionsRemimazolam 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.Copyright © 2018 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

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