A double-blind group comparative study using the new anti-depressant Org 3770, placebo and diazepam in patients with expected insomnia and anxiety before elective gynaecological surgery.
Two hundred and fifty female patients about to undergo elective gynaecological surgery, were randomly allocated to a single oral dose of either 5, 15, 30 mg Org 3770, placebo, or 10 mg diazepam the evening before operation. Assessment of sleep quality next morning using self-rated questionnaires showed that both Org 3770 and diazepam were significantly better than placebo in enhancing sleep. In addition, a dose-response effect was seen with Org 3770, 15 mg seeming optimal. Assessment of presurgery anxiety, again using self-rated questionnaires, showed that 15 mg Org 3770, and 10 mg diazepam were significantly more effective than placebo at reducing anxiety. None of the medications produced any troublesome side effects nor did they have an effect on blood pressure.
D000328:Adult; D001007:Anxiety / Q000188:drug therapy*; D001794:Blood Pressure / Q000187:drug effects; D003975:Diazepam / Q000009:adverse effects / Q000627:therapeutic use*; D003984:Dibenzazepines / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008803:Mianserin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use*; D000078785:Mirtazapine; D011292:Premedication; D011897:Random Allocation; D007319:Sleep Initiation and Maintenance Disorders / Q000517:prevention & control*
D003984:Dibenzazepines; D008803:Mianserin; D000078785:Mirtazapine; D003975:Diazepam