Reversal of flunitrazepam sedation with flumazenil. A randomized clinical trial

Fifty-nine male patients scheduled for transurethral resection of the prostate under flunitrazepam sedation and spinal analgesia were randomized in a double-blind trial to reversal of sedation with either the benzodiazepine antagonist flumazenil or placebo. Judged by degree of sedation, comprehension and cooperation as well as by estimation of orientation in time and space, flumazenil was superior to placebo (P less than 0.001). The median duration of anterograde amnesia was 16 min after flumazenil and 75 min after placebo (P less than 0.001). Adverse events were more frequent with placebo (P greater than 0.05), while no differences were evident with regard to laboratory data or cardiorespiratory function.