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

Pastis NJ et al

CHEST 2019; 155(1):137-146 045;


What is the key question?

  • Midazolam remains the most widely used sedative agent for bronchoscopy. However it is associated with an elimination half-life of 1.8-6.4 hours and can cause prolonged post procedure sedation.
  • Remimazolam (RM) in previous phase two studies demonstrated adequate sedation and more rapid recovery than midazolam (MZ)

What is the bottom line?

  • In this prospective, double-blinded, randomized, multicentre, parallel group trial performed at 30 US sites RM was compared to placebo or open labelled MZ.
  • 446 patients were evaluated. Mean age was 62 with similar baseline characteristics.
  • Initial dose was 5 mg RM and 1.75 mg MZ in healthy adults <60 years (1mg >60 yrs of chronic illness). Top up doses were 2.5 mg RM, 1 mg MZ (0.5 if >60 yrs of chronic illness)
  • Primary outcome was successful procedure which was a composite of completion of procedure, no requirement for rescue sedative, or less than 3-5 boluses of study drug in 12-15 minutes. Success rates were 80.6%, 4.8% and 32.9% in RM, placebo and MZ groups, respectively.
  • Mean dose of concomitant per-protocol fentanyl administered were 82, 120 and 107 mcg in RM, placebo and MZ groups, respectively.
  • Time to full alertness after bronchoscopy was significantly shorter in RM patients (median 6 minutes) in comparison to placebo (13.6 minutes) and MZ (12 minutes).

Why read on?

  • The authors further discuss these results with reference to guidelines for sedation, patient subgroups and the use of reversal agents.