In this double-blind placebo-controlled trial were studied the efficacy and safety of
Flumazenil (
Anexate) administered postoperatively for reversing the central effects of
midazolam. Fifty-nine patients were sedated with
midazolam for surgery under epidural or spinal anaesthesia. At the end of operations
Flumazenil was i.v. injected in incremental doses up to the awakening of the patient or to a maximal dose of 1 mg. The parameters of efficacy (degree of sedation,
amnesia, orientation and collaboration) and safety (vital signs, vital capacity), adverse reactions and the patient's subjective assessment were recorded up to 240 min after the injection of the trial
drug. With efficacious doses of 0.2 mg-0.4 mg the
Flumazenil group showed a significant improvement in collaboration and in reversing sedation and
amnesia up to 30 min after the injection of the antagonist. The relatively short duration of action of
Flumazenil can lead to secondary sleep and
amnesia episodes. The vital signs remained stable after the administration of the trial
drug. Patients assessed their subjective satisfaction on the awakening. There were no severe adverse reactions after
Flumazenil.