In two double-blind, randomized trials the efficacy and safety of
flumazenil, the first
benzodiazepine antagonist, were assessed in 100 adult patients undergoing gastroscopy under
diazepam or
midazolam sedation. The criteria of efficacy were the degree of sedation and
anterograde amnesia. The median gastroscopy time was 20 min (range 5-40 min). The
diazepam group received median 30 mg (range 15-60 mg)
Diazemuls and the
midazolam group median 15 mg (range 10-40 mg)
Dormicum. Both groups were antagonized by median 0.42 mg
flumazenil (range 0.4-0.6 mg). There was no inter-group difference with regard to blood pressure, heart rate and respiration rate. There was a significantly faster recovery of the patients after injection of
flumazenil than after placebo. Patients were awake shortly after
flumazenil, but remained drowsy or asleep after placebo administration. All patients, regardless of
diazepam or
midazolam sedation, antagonized with
flumazenil were awake within 5 min and remained awake during the whole observation period of 3 h. The
amnesia was totally eliminated by
flumazenil. There were no significant differences in side-effects between the groups.