Flumazenil used for reversal of midazolam-induced sedation in endoscopy outpatients.

A double-blind, placebo-controlled randomized clinical study was performed in 69 outpatients scheduled for endoscopy and sedated with midazolam to assess the efficacy, safety, and usefulness of flumazenil in reversing the effects of midazolam-induced sedation. Midazolam was administered intravenously before endoscopy up to a maximum dose of 15 mg. After endoscopy either flumazenil or placebo was injected. Vital signs and psychomotoric tests were assessed before injection of midazolam, before injection of flumazenil or placebo, and 5, 15, 30, 60, 240, and 360 min afterward. Thirty-six patients received flumazenil, 33 placebo. All parameters returned to pre-sedation levels within 5 min in all patients in the flumazenil group, with significant differences as compared with placebo after 5, 15, 30, and 60 min. Flumazenil was well tolerated. No rebound sedation was observed. Flumazenil is a safe and effective benzodiazepine antagonist. The combination of midazolam with flumazenil makes it possible to reduce the recovery period and is useful in outpatient endoscopy.

RCT Entities:   Population Interventions Outcomes