Hydroxyzine premedication--does it provide better anxiolysis than a placebo?
OBJECTIVE
To 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.


METHODS
Double-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.


METHODS
Hillbrow Hospital, Johannesburg.


METHODS
Sixty 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.


METHODS
Hydroxyzine (Aterax) 1-2 mg/kg, or a placebo administered orally as anaesthetic premedication.


METHODS
Anxiolytic 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).


RESULTS
A 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.


CONCLUSIONS
Hydroxyzine, 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.
Boon
J H
JH
Department of Anaesthesia, Hillbrow Hospital, Johannesburg.
Hopkins
D
D
D000284:Administration, Oral; D000328:Adult; D000704:Analysis of Variance; D014151:Anti-Anxiety Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001007:Anxiety / Q000503:physiopathology / Q000517:prevention & control; D003376:Counseling; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006919:Hydroxyzine / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage / Q000627:therapeutic use; D011229:Preanesthetic Medication; D011446:Prospective Studies; D013997:Time Factors
D014151:Anti-Anxiety Agents; D010919:Placebos; D006919:Hydroxyzine