STUDY OF MIDAZOLAM ON PREOPERATIVE SLEEP

  • 1 January 1981
    • journal article
    • research article
    • Vol. 22  (1) , 22-26
Abstract
To determine the hypnotic effects of midazolam administered per os, the drug was compared with meprobamate and a placebo in patients about to undergo surgery. The study involved 83 patients, 57 female and 26 male: 67 cases of maxillofacial surgery and 16 cases of gynecological surgery. The study was carried out using the technique of comparison in parallel series of single doses of midazolam (15 mg) with meprobamate (250 mg) and a placebo according to the double placebo technique. The patients were aged between 18-60 yr, male and female, and were included without any particular attention being paid to sufferers from sleep disturbances or not. The variables selected for the study were 29 in number concerning the assessment of the patient of sleep and awakening, surveillance of the time taken to fall asleep, the duration and quality of sleep and the state after awakening. Twenty-seven patients received the placebo (group A), 26 midazolam (group B) and 30 meprobamate (group C). The 3 groups thus constituted were comparable. Midazolam and meprobamate were associated with a shorter period required to fall asleep than the placebo, this period also being shorter with midazolam than with meprobamate. As assessed by the patient, these periods were 103 .+-. 73 min in A, 35 .+-. 36 min in B and 68 .+-. 41 min in C (A-B, P = 0.00016, A-C, P = 0.0368, B-C, P = 0.0032). This was confirmed by surveillance, which showed that at 30 min, 42% of the patients of group B had fallen asleep as against 14.8% in group A and 6.6% in group C (A-B, P = 0.026, B-C, P = 0.0016); sleep was longer in B (7.5 h) and in C (7.05 h) than in A (5.4 h) (A-B, P = 0.006, A-C, P = 0.023). The quality of awakening assessed by the patient in terms of pleasant-unpleasant was similar in group A and group B but was more pleasant in group C (A-B, P = 0.05, C-B, P = 0.028, C-A P = 0.007). The latter was not confirmed by the examination of the physician which only revealed a sensation of feeling off color in A in comparison with B (P = 0.05) and C (P = 0.005).

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