Flumazenil used in the antagonizing of diazepam and midazolam sedation in out-patients undergoing gastroscopy.

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.

RCT Entities:   Population Interventions Outcomes