Clinical therapeutics
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Clinical therapeutics · Nov 1992
Randomized Controlled Trial Multicenter Study Clinical TrialReversal of central nervous system effects by flumazenil after intravenous conscious sedation with midazolam: report of a multicenter clinical study. The Flumazenil in Intravenous Conscious Sedation with Midazolam Multicenter Study Group I.
Flumazenil, a benzodiazepine antagonist, reverses the residual central nervous system effects of benzodiazepines. In this US double-blind, multicenter study, the efficacy of flumazenil was compared with that of placebo in antagonizing the effects of midazolam, a benzodiazepine used to induce intravenous conscious sedation. The mean dose of flumazenil was 0.7 mg, administered intravenously. ⋯ Flumazenil was well tolerated. Dizziness (10%) and nausea (9%) were the most frequently reported adverse effects. Results of this study demonstrate that flumazenil antagonizes the central nervous system effects of midazolam after intravenous conscious sedation.
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Clinical therapeutics · Nov 1992
Randomized Controlled Trial Multicenter Study Clinical TrialReversal of central benzodiazepine effects by intravenous flumazenil after conscious sedation with midazolam and opioids: a multicenter clinical study. The Flumazenil in Intravenous Conscious Sedation with Midazolam Multicenter Study Group II.
The efficacy and safety of flumazenil in antagonizing the central effects of the benzodiazepine midazolam was demonstrated in patients in whom conscious sedation was induced with midazolam plus an opioid (fentanyl, meperidine, or morphine). In a double-blind, multicenter study, 240 patients were administered flumazenil postoperatively at an average intravenous dose of 0.7 mg (7 ml) and 114 patients were administered an average dose of 9 ml placebo. Complete reversal of sedation was observed in 80% of flumazenil-treated patients and 30% of placebo-treated patients 5 minutes posttreatment. ⋯ Flumazenil was well tolerated, although adverse effects were reported slightly more often than in the placebo group. The most frequent adverse events in both groups were dizziness and nausea. Vital signs were not affected.
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Clinical therapeutics · Nov 1992
Randomized Controlled Trial Multicenter Study Clinical TrialReversal of central benzodiazepine effects by flumazenil after conscious sedation produced by intravenous diazepam. The Flumazenil in Intravenous Conscious Sedation with Diazepam Multicenter Study Group I.
Flumazenil is a competitive benzodiazepine antagonist that rapidly reverses the residual effects of benzodiazepines following intravenous conscious sedation. In a double-blind, multicenter study, postoperative patients who had been sedated with intravenous diazepam were randomly allocated to receive intravenous doses of flumazenil (0.4 mg to 1 mg) or placebo. Levels of sedation and psychomotor impairment were evaluated prestudy, at baseline, and at 6 intervals from 5 to 180 minutes posttreatment. ⋯ There were no serious adverse experiences related to the test drug. Flumazenil provided prompt, controlled reversal of residual effects, especially sedation, in the majority (84%) of patients recovering from intravenous conscious sedation induced by diazepam. For most (70%) of these flumazenil-treated patients, the reversal was maintained throughout the 180-minute assessment.
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Clinical therapeutics · Nov 1992
Randomized Controlled Trial Multicenter Study Clinical TrialEffect of intravenous flumazenil on reversal of the central effects of midazolam used with short-acting opioids for general anesthesia in hospitalized patients: report of a multicenter, double-blind clinical study. The Flumazenil in General Anesthesia in Hospitalized Patients Study Group I.
Midazolam, a short-acting benzodiazepine central nervous system (CNS) depressant widely used for the induction and maintenance of general anesthesia, is often supplemented with short-acting opioids for general anesthesia. Administered postoperatively, flumazenil, a specific benzodiazepine antagonist, reverses the CNS sedative effects of midazolam. In a double-blind clinical trial in hospitalized patients, flumazenil, administered postoperatively at an average intravenous dose of 0.89 mg (range: 0.4 mg to 1 mg), was more effective than placebo in reversing sedation and other residual effects of benzodiazepines in patients recovering from general anesthesia induced by midazolam (mean dose 29 mg) in conjunction with fentanyl (mean dose 0.4 mg) or sufentanil (mean dose 0.056 mg). ⋯ Measurements of psychomotor function and memory also showed significant between-group differences. Flumazenil, compared with placebo, was not associated with a substantially greater frequency of operative-site pain. These results demonstrate that the efficacy and safety of flumazenil were not compromised by the addition of a short-acting opioid to the anesthetic regimen.
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Clinical therapeutics · Nov 1992
Randomized Controlled Trial Multicenter Study Clinical TrialReversal of the central effects of midazolam by intravenous flumazenil after general anesthesia and use of a long-acting opioid in hospitalized patients: report of a multicenter double-blind clinical study. The Flumazenil in General Anesthesia in Hospitalized Patients Study Group II.
A double-blind clinical trial was conducted to evaluate the efficacy and safety of flumazenil, a benzodiazepine antagonist, in 146 hospitalized patients, who had had general anesthesia induced by midazolam and a long-acting opioid. Ninety-eight patients received flumazenil and 48 received placebo. Administered postoperatively at a mean intravenous dose of 0.84 mg (range: 0.2 mg to 1 mg), flumazenil reversed benzodiazepine-induced sedation to a greater extent than did placebo. ⋯ Flumazenil, compared with placebo, was not associated with an increased frequency of operative-site pain, and no serious adverse effects of this benzodiazepine antagonist were reported. The most frequent adverse experiences in both treatment groups were nausea, shivering, and operative-site pain. Vomiting, dizziness, and injection-site reactions were also reported in > or = 5% of patients treated with flumazenil.