Reversal of central nervous system effects by flumazenil after intravenous conscious sedation with midazolam: report of a multicenter clinical study. The Flumazenil in Intravenous Conscious Sedation with Midazolam Multicenter Study Group I.
Flumazenil, a benzodiazepine antagonist, reverses the residual central nervous system effects of benzodiazepines. In this US double-blind, multicenter study, the efficacy of flumazenil was compared with that of placebo in antagonizing the effects of midazolam, a benzodiazepine used to induce intravenous conscious sedation. The mean dose of flumazenil was 0.7 mg, administered intravenously. At 5 minutes posttreatment, 82% of 131 flumazenil-treated patients, compared with 15% of 65 placebo-treated patients, demonstrated complete reversal of sedation. In 85% of patients who responded to flumazenil, this reversal of sedation was maintained throughout the 180-minute observation period. Psychomotor performance returned to prestudy levels 5 minutes posttreatment in 87% of the flumazenil-treated patients, compared with 28% of the placebo-treated patients. At the doses administered, flumazenil was less effective in reversing midazolam-induced amnesia, with only 60% of patients demonstrating partial recovery of memory. It was, nevertheless, more effective than placebo. Flumazenil was well tolerated. Dizziness (10%) and nausea (9%) were the most frequently reported adverse effects. Results of this study demonstrate that flumazenil antagonizes the central nervous system effects of midazolam after intravenous conscious sedation.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002490:Central Nervous System / Q000187:drug effects*; D016292:Procedural Sedation; D004311:Double-Blind Method; D005069:Evaluation Studies as Topic; D005260:Female; D005442:Flumazenil / Q000009:adverse effects / Q000494:pharmacology*; D006801:Humans; D008297:Male; D011939:Mental Recall / Q000187:drug effects; D008874:Midazolam / Q000037:antagonists & inhibitors*; D008875:Middle Aged; D011597:Psychomotor Performance
D005442:Flumazenil; D008874:Midazolam