A double-blind, randomized, multicenter study evaluated the effect of flumazenil on postoperative status in 192 adult patients who underwent surgical procedures requiring general anesthesia. Midazolam was given for induction or maintenance of general anesthesia. Placebo (n = 96) or flumazenil (n = 96) was administered postoperatively after extubation at a dose of 2 ml every minute until patients were sufficiently alert (Observer's Assessment of Alertness/Sedation [OAA/S] score of 4 or 5). Data were obtained 5 minutes after injection, during transport to the recovery room, and at specified times up to 30 minutes in the recovery room. The mean total doses were 6.3 ± 2.6 ml (0.63 ± 0.26 mg) of flumazenil and 8.5 ± 2.4 ml of placebo; and 13.8 ± 4.9 mg of midazolam in the flumazenil group and 14.3 ± 5.0 mg of midazolam in the placebo group (NS). During transport, flumazenil-treated patients were better able to comprehend and cooperate than those given placebo (85% versus 59%). Mean OAA/S composite scores showed that patients given flumazenil were more alert (P < 0.05) during transport and through the first 15 minutes in the recovery room. The incidence of drug-related adverse events was 8% in the flumazenil group and 4% in the placebo group. Overall, the use of flumazenil in patients who had received midazolam for induction and/or maintenance of anesthesia effectively reversed sedation and was associated with improved alertness and better comprehension, cooperation, and recall during transport and during the first 15 minutes in the recovery room.
ASJC Scopus subject areas
- Pharmacology (medical)