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. 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 < .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. 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.
journal_name
Chestjournal_title
Chestauthors
Pastis NJ,Yarmus LB,Schippers F,Ostroff R,Chen A,Akulian J,Wahidi M,Shojaee S,Tanner NT,Callahan SP,Feldman G,Lorch DG Jr,Ndukwu I,Pritchett MA,Silvestri GA,PAION Investigators.doi
10.1016/j.chest.2018.09.015subject
Has Abstractpub_date
2019-01-01 00:00:00pages
137-146issue
1eissn
0012-3692issn
1931-3543pii
S0012-3692(18)32498-Xjournal_volume
155pub_type
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