[Effectiveness and tolerance of flumazenil in regional anesthesia with midazolam sedation].
In this double-blind placebo-controlled trial were studied the efficacy and safety of Flumazenil (Anexate) administered postoperatively for reversing the central effects of midazolam. Fifty-nine patients were sedated with midazolam for surgery under epidural or spinal anaesthesia. At the end of operations Flumazenil was i.v. injected in incremental doses up to the awakening of the patient or to a maximal dose of 1 mg. The parameters of efficacy (degree of sedation, amnesia, orientation and collaboration) and safety (vital signs, vital capacity), adverse reactions and the patient's subjective assessment were recorded up to 240 min after the injection of the trial drug. With efficacious doses of 0.2 mg-0.4 mg the Flumazenil group showed a significant improvement in collaboration and in reversing sedation and amnesia up to 30 min after the injection of the antagonist. The relatively short duration of action of Flumazenil can lead to secondary sleep and amnesia episodes. The vital signs remained stable after the administration of the trial drug. Patients assessed their subjective satisfaction on the awakening. There were no severe adverse reactions after Flumazenil.
D000328:Adult; D000368:Aged; D000767:Anesthesia, Epidural; D000775:Anesthesia, Spinal; D001143:Arousal / Q000187:drug effects; D002986:Clinical Trials as Topic; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005442:Flumazenil; D006801:Humans; D008874:Midazolam / Q000008:administration & dosage*; D008875:Middle Aged; D011229:Preanesthetic Medication
D005442:Flumazenil; D008874:Midazolam
Wirksamkeit und Verträglichkeit von Flumazenil nach Regionalanästhesie unter Midazolam-Sedation.