• J H Boon and D Hopkins.
• Department of Anaesthesia, Hillbrow Hospital, Johannesburg.
• S. Afr. Med. J. 1996 Jun 1;86(6):661-4.

ObjectivesTo determine how effective hydroxyzine is compared with a placebo in providing pre-operative anxiolysis in our hospital population, and to assess the anxiolytic effect of our pre-operative visit.DesignDouble-blind, randomised, prospective, controlled trial. Anxiety levels assessed with visual analogue scales (VAS), by patient and investigator. Haemodynamic parameters measured: heart rate, blood pressure, respiratory rate.SettingHillbrow Hospital, Johannesburg.ParticipantsSixty female patients aged 20-60 years, American Society of Anesthesiologists status I-III, scheduled for elective gynaecological surgery under general anaesthesia. The overall participation rate was 100%. All cases were randomly selected.InterventionHydroxyzine (Aterax) 1-2 mg/kg, or a placebo administered orally as anaesthetic premedication.Outcome MeasuresAnxiolytic effect of agents and of pre-operative visit. Time interval between premedication and induction of anaesthesia. Blood pressure, heart rate, respiratory rate, other signs of autonomic hyperactivity (restlessness, tremors, sweating).ResultsA statistically significant reduction in anxiety followed the administration of hydroxyzine (P < 0.05) and the placebo (P < 0.03); however, no statistically or clinically significant difference could be demonstrated between the two agents. No significant anxiolysis occurred following the premedication visit. The average premedication-induction interval was 72 minutes. There were no significant differences in haemodynamic parameters between the two groups.ConclusionsHydroxyzine, in the dose administered and after an appropriate premedication-induction interval, provided no better anxiolysis than a placebo in the pre-operative period. No significant anxiolytic effect was demonstrated by our routine premedication visit.

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