October 30, 2018
Time to achieving full alertness at the conclusion of the bronchoscopy was significantly shorter in patients treated with remimazolam.
The use of remimazolam, administered under the supervision of a pulmonologist, has been shown to be safe and effective for achieving moderate sedation in patients who are undergoing flexible bronchoscopy and may have a shorter time of onset and faster neuropsychiatric recovery compared with midazolam.
A prospective, double-blind, randomized, multicenter, parallel-group study on the subject was conducted at 30 sites in the United States, with results published in CHEST.
Investigators sought to compare the efficacy and safety of remimazolam with both placebo and open-label midazolam during diagnostic and therapeutic flexible bronchoscopy procedures in 446 patients ≥18 years of age. They reported a success rate of 80.6% in the remimazolam group, 32.9% in the midazolam group, and 4.8% (P <.0001) in the placebo group.
When remimazolam was used, bronchoscopy was initiated sooner (mean, 6.4±5.82 min) compared with placebo (mean, 17.2±4.15 min; P <.0001) or midazolam (mean, 16.3±8.60 min). Moreover, time to achieving full alertness at the conclusion of the bronchoscopy was significantly shorter in patients treated with remimazolam (median, 6.0 min; 95% CI, 5.2-7.1) compared with patients given placebo (13.6 min; 95% CI, 8.1-24.0; P =.0001) or midazolam (median, 12.0 min; 95% CI, 5.0-15.0).
Superior restoration of neuropsychiatric function was reported in those who received remimazolam (at 5 minutes) compared with those treated with midazolam or placebo. Safety was comparable among the 3 arms, with 5.6% of patients treated with remimazolam experiencing treatment-emergent adverse events vs 6.8% of patients given placebo.
The investigators concluded that the use of remimazolam was safe and effective for attaining moderate sedation in patients undergoing flexible bronchoscopy procedures. The agent can be used under the supervision of a pulmonologist without the presence of an anesthesiologist in the bronchoscopy suite. This is the first time in almost 3 decades that a new treatment option has become available for sedation in this setting.
Pastis NJ, Yarmus LB, Schippers F, et al. Safety and efficacy of remimazolam compared to placebo and midazolam for moderate sedation during bronchoscopy [published online October 4, 2018]. CHEST. doi:10.1016/j.chest.2018.09.015