[Evaluation of the efficacy and tolerance of flumazenil in antagonism of the effects of flunitrazepam on the central nervous system].
The efficacy and tolerance of flumazenil were assessed in a double-blind randomized multicentre trial on 120 ASA I or II patients aged 40.3 +/- 13.9 years. They were anaesthetized with flunitrazepam (25.1 +/- 10.5 micrograms.kg-1.h-1), fentanyl (4.4 +/- 1.9 micrograms.kg-1.h-1) and either vecuronium or pancuronium; residual neuromuscular blockade was antagonized at the end of surgery. 61 patients received flumazenil and 59 a placebo. Sedation comprehension and temporo-spatial orientation were scored at 0, 5, 15, 30, 60, 120 and 240 min after the administration of flumazenil or placebo. Local and general tolerances were evaluated 1 h and 24 h after administration. At the 24th h, the observer's assessment of consciousness, pain, respiration, coughing and vomiting were noted, as well as his identification, or not, of flumazenil or the placebo and their efficacy. Both groups were statistically homogeneous and comparable. Significant and marked efficacy was noted between the 5th and 30th min. There was no difference, at 24 h, between the flumazenil and placebo groups. In most cases, flumazenil was identified by the observer and its efficacy felt to be excellent. No major untoward effect of flumazenil was noted; however a mild and short lasting anxiety occurred in three patients. Tolerance was deemed to be excellent.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000762:Anesthesia Recovery Period; D000768:Anesthesia, General / Q000379:methods; D002490:Central Nervous System / Q000187:drug effects*; D002986:Clinical Trials as Topic; D005260:Female; D005442:Flumazenil / Q000494:pharmacology*; D005445:Flunitrazepam / Q000037:antagonists & inhibitors* / Q000494:pharmacology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos
D010919:Placebos; D005442:Flumazenil; D005445:Flunitrazepam
Evaluation de l'efficacité et de la tolérance du flumazénil dans l'antagonisme des effets du flunitrazépam sur le système nerveux central.