Safety and Efficacy of Remimazolam Compared With Placebo and Midazolam for Moderate Sedation During Bronchoscopy

[摘要] 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. 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. Results The success rates were 80.6% in the remimazolam arm, 4.8% in the placebo arm (P P 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. 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.

[学科分类] 呼吸医学

[关键词] flexible bronchoscopy;Modified Observer’s Assessment of Alertness/Sedation Scale;monitored anesthesia care;remimazolam;ASA;American Society of Anesthesiologists;FDA;US Food and Drug Administration;MOAA/S;Modified Observer’s Assessment of Alertness/Sedation Scale