Flunitrazepam Versus Placebo Premedication for Minor Surgery

Abstract

The clinical effects of oral flunitrazepam [FZ] (2 mg the night before operation followed by 2 mg on the morning of operation) and placebo as premedicants were tested in a double-blind study in 81 gynecological patients. The separate or total concentrations of FZ and its demethylated metabolite in plasma (measured by gas chromatography) were correlated with the clinical effects of FZ premedication, assessed both subjectively and objectively. In most parameters tested (sleep on the night before operation, sedation, apprehension, headache, pulse rate), there was a positive, significant difference between the FZ group (n = 44) and the placebo group (n = 37). No significant difference was found between the 2 groups in emetic effect, excitement, systolic blood pressure increase, and venipuncture, but the patients receiving FZ felt significantly more dizziness. The temperature of the left forefinger before, during and after the anesthesia did not vary significantly between the 2 groups. There was no correlation between the plasma concentration of FZ and its demethylated metabolite (separate or total concentration) and any of the parameters tested before induction of anesthesia. FZ is a new oral premedicant with prominent sedative and anxiolytic actions. When the drug is given as a sedative on the night before operation followed by 2nd dose on the morning of operation, the beneficial effects last for at least 8 h after the 2nd dose.