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Randomized Controlled Trial Comparative Study Clinical Trial
[Multidimensional psychometric assessment of preoperative mood. Effects of zolpidem compared to phenobarbital combined with promethazine as premedication].
- T Uhlig, M Hüppe, and B Nidermaier.
- Institut für Anästhesiologie und Intensivmedizin, Leopoldina Krankenhauses Schweinfurt, Universität Würzburg.
- Anaesthesist. 1995 Sep 1; 44 (9): 634-42.
AbstractThe following double-blind, randomised study dealt with three questions: (1) Is a multidimensional psychometric rating scale suitable for the measurement of mood before anaesthesia? (2) What are the effects of the new benzodiazepine-like drug zolpidem on preoperative mood compared with phenobarbital? (3) Is the combination with Promethazine suggestive? METHODS. Three hundred and four patients were assigned to four groups (group 1: zolpidem 8.03 mg/promethazine 50 mg; group 2: zolpidem 8.03 mg/placebo; group 3: phenobarbital 100 mg/promethazine 50 mg; group 4: phenobarbital 100 mg/placebo). The drugs were given the evening before anaesthesia (09:30-10:00 p.m.). The sample was shifted by age and sex. Mood was measured by a multidimensional rating scale, which assessed aspects of elated mood, anxiety, hostility, deactivation, vigilance, and introversion. Statistics were performed using analysis of variance (ANOVA). RESULTS. Zolpidem led to significantly higher expressions of hostility (negative mood, irritability, aggressiveness) than phenobarbital. Compared with placebo, promethazine led to greater deactivation (more tiredness and numbness, lower level of wakefulness). Specific emotions and somatic aspects were not affected. Patients who had received promethazine received a lower dose of thiopentone for induction of anaesthesia than patients with placebo. CONCLUSIONS. Zolpidem and phenobarbital have many common effects on preoperative mood. Differences were found in the unspecific emotional aspects of agitation and hostility. These negative effects must be weighed against the pharmacokinetic and pharmacodynamic advantages of zolpidem when this drug is administered for premedication. The effects of zolpidem seem to be more sedative than anxiolytic. The study shows that a combination with promethazine is suggestive, because promethazine has a selective deactivating effect. The finding that promethazine lowers the dose of thiopentone required for induction of anaesthesia is an additional interesting point. The results of this study highlight the importance of using multidimensional rating scales for the measurement of mood before anaesthesia.
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