TY - JOUR
T1 - Postoperative use of flumazenil
T2 - Multicenter assessment of benefit to inpatients after general anesthesia
AU - Berry, James M.
AU - Bartkowski, Richard R.
AU - Bikhazi, George B.
AU - Richter, James J.
AU - Chelly, Jacques E.
N1 - Funding Information:
Alford, RN, BS, with Hermann Hospital and affiliated with The University of Texas Medical School, Department of Anesthesiology, Houston, Texas. This study was supported in part by Roche Laboratories, a division of Hoffmann-La Roche Inc., Nutley, New Jersey.
PY - 1993/4
Y1 - 1993/4
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=0027164662&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0027164662&partnerID=8YFLogxK
U2 - 10.1016/S0011-393X(05)80201-2
DO - 10.1016/S0011-393X(05)80201-2
M3 - Article
AN - SCOPUS:0027164662
SN - 0011-393X
VL - 53
SP - 413
EP - 426
JO - Current Therapeutic Research
JF - Current Therapeutic Research
IS - 4
ER -