Clinical and biochemical evaluations of premedicants. A double-blind assessment of clobazam, a new 1,5 benzodiazepine.

Clobazam is a new 1,5 benzodiazepine which differs from the 1,4 benzodiazepines such as diazepam, in that it displays a wide separation of its tranquillising or anxiolytic effects from impairment of cortical arousal and psychomotor performance. Its potential advantages as a premedicant for day-case or outpatient surgery were evaluated in a placebo-controlled double-blind study in female patients undergoing minor day surgery. Anxiety reduction was evaluated clinically and by means of plasma cortisol estimations. The clinical evaluation, using an established portocol, did not differentiate either active drug from placebo or between the active drugs; the cortisol results permitted opposing conclusions depending on the statistical approach used. Potential fallacies inherent in the methodology current used for evaluating premedicant drugs are discussed.

RCT Entities:   Population Interventions Outcomes