Antagonism of diazepam-induced sedative effects by Ro15-1788 in patients after surgery under lumbar epidural block. A double-blind placebo-controlled investigation of efficacy and safety.
The aim of this study was to assess the efficacy of Ro15-1788 and a placebo in reversing diazepam-induced effects after surgery under epidural block, and to evaluate the local tolerance and general safety of Ro15-1788. Fifty-seven patients were sedated with diazepam for surgery under epidural anaesthesia. Antagonism of diazepam-induced effects by Ro15-1788 was investigated postoperatively in a double-blind placebo-controlled trial. The patient's subjective assessment of mood rating, an objective test of performance, a test for amnesia, and vital signs were recorded for up to 300 min after administration of the trial drug. No significant differences between the two groups were observed for mood rating, amnesia, or vital signs. The Ro15-1788 group showed a significant improvement in the performance test up to 120 min after administration of the drug. There was no evidence of reaction at the injection site.
D000328:Adult; D000368:Aged; D000647:Amnesia / Q000139:chemically induced; D000767:Anesthesia, Epidural; D002986:Clinical Trials as Topic; D003975:Diazepam / Q000009:adverse effects / Q000037:antagonists & inhibitors*; D004311:Double-Blind Method; D004644:Emotions / Q000187:drug effects; D005260:Female; D005442:Flumazenil / Q000009:adverse effects / Q000494:pharmacology*; D006801:Humans; D006993:Hypnotics and Sedatives / Q000009:adverse effects / Q000037:antagonists & inhibitors*; D008297:Male; D008875:Middle Aged; D011597:Psychomotor Performance / Q000187:drug effects; D011897:Random Allocation
D006993:Hypnotics and Sedatives; D005442:Flumazenil; D003975:Diazepam