The effectiveness of flumazenil in reversing the sedation and amnesia produced by intravenous midazolam.

In this double-blind study 31 outpatients undergoing third molar extraction were randomly assigned to one of two groups. All patients were sedated with intravenous midazolam (IV) by titration method. The flumazenil group (n = 20) received an average of 0.8 +/- 0.17 mg of flumazenil IV. The placebo patients (n = 11) each received 10 mL of normal saline. By both observer and patient alertness ratings, patients receiving flumazenil appeared significantly more alert than placebo patients at 5, 15, 30, and 60 minutes following reversal. After reversal the flumazenil group had significantly higher scores than the placebo group at all intervals through 60 minutes. All the patients receiving flumazenil were able to walk without assistance at 5 minutes, compared with only one patient in the placebo group, and more patients in the flumazenil group recognized the picture card shown to them at 5, 15, 30, and 60 minutes postreversal. Flumazenil is effective in terminating the amnestic properties of midazolam, but this appears to occur to a lesser extent than the reversal of its sedative properties.

RCT Entities:   Population Interventions Outcomes