Reversal of central benzodiazepine effects by flumazenil after conscious sedation produced by intravenous diazepam

John W Bloom, D. A. Chernik, A. B. Davidson, R. A. Dionne, M. M. Ghoneim, J. Goff, R. T. Keller, C. T. Mora, C. Pablo, J. L. Siegel

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

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. A global evaluation of effectiveness was made at the 5-minute assessment, and memory was assessed at the 180-minute assessment. Flumazenil (mean dose: 0.73 mg [7.3 ml]) was significantly more effective than placebo (mean dose: 8.9 ml) in reversing sedation, psychomotor impairment, and amnesia within 5 minutes after the start of administration. At the 5 minute posttreatment assessment, 84% of 102 flumazenil-treated patients (compared with 42% of 52 placebo-treated patients) experienced complete reversal of sedation. Ninety-two percent of 93 flumazenil-treated patients (compared with 41% of 46 placebo-treated patients) had normal psychomotor function. Reversal of amnesia at the 5-minute assessment was achieved in 75% of 101 flumazenil-treated patients and in 20% of 51 placebo-treated patients. Statistically significant differences between flumazenil and placebo were also observed at the 15-minute assessment. Thereafter there were no significant differences between the two treatment groups. Most (70%) flumazenil-treated patients exhibited no recurrence of sedation during the 180 minute assessment period. The most frequent adverse reaction in the flumazenil group was dizziness (6%). 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.

Original languageEnglish (US)
Pages (from-to)895-909
Number of pages15
JournalClinical Therapeutics
Volume14
Issue number6
StatePublished - 1992

Fingerprint

Conscious Sedation
Flumazenil
Diazepam
Benzodiazepines
Placebos
Psychomotor Disorders
Amnesia
Dizziness
Double-Blind Method
Multicenter Studies

ASJC Scopus subject areas

  • Pharmacology

Cite this

Bloom, J. W., Chernik, D. A., Davidson, A. B., Dionne, R. A., Ghoneim, M. M., Goff, J., ... Siegel, J. L. (1992). Reversal of central benzodiazepine effects by flumazenil after conscious sedation produced by intravenous diazepam. Clinical Therapeutics, 14(6), 895-909.

Reversal of central benzodiazepine effects by flumazenil after conscious sedation produced by intravenous diazepam. / Bloom, John W; Chernik, D. A.; Davidson, A. B.; Dionne, R. A.; Ghoneim, M. M.; Goff, J.; Keller, R. T.; Mora, C. T.; Pablo, C.; Siegel, J. L.

In: Clinical Therapeutics, Vol. 14, No. 6, 1992, p. 895-909.

Research output: Contribution to journalArticle

Bloom, JW, Chernik, DA, Davidson, AB, Dionne, RA, Ghoneim, MM, Goff, J, Keller, RT, Mora, CT, Pablo, C & Siegel, JL 1992, 'Reversal of central benzodiazepine effects by flumazenil after conscious sedation produced by intravenous diazepam', Clinical Therapeutics, vol. 14, no. 6, pp. 895-909.
Bloom, John W ; Chernik, D. A. ; Davidson, A. B. ; Dionne, R. A. ; Ghoneim, M. M. ; Goff, J. ; Keller, R. T. ; Mora, C. T. ; Pablo, C. ; Siegel, J. L. / Reversal of central benzodiazepine effects by flumazenil after conscious sedation produced by intravenous diazepam. In: Clinical Therapeutics. 1992 ; Vol. 14, No. 6. pp. 895-909.
@article{16a6e89ce1ab470296ba29feef7279ed,
title = "Reversal of central benzodiazepine effects by flumazenil after conscious sedation produced by intravenous diazepam",
abstract = "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. A global evaluation of effectiveness was made at the 5-minute assessment, and memory was assessed at the 180-minute assessment. Flumazenil (mean dose: 0.73 mg [7.3 ml]) was significantly more effective than placebo (mean dose: 8.9 ml) in reversing sedation, psychomotor impairment, and amnesia within 5 minutes after the start of administration. At the 5 minute posttreatment assessment, 84{\%} of 102 flumazenil-treated patients (compared with 42{\%} of 52 placebo-treated patients) experienced complete reversal of sedation. Ninety-two percent of 93 flumazenil-treated patients (compared with 41{\%} of 46 placebo-treated patients) had normal psychomotor function. Reversal of amnesia at the 5-minute assessment was achieved in 75{\%} of 101 flumazenil-treated patients and in 20{\%} of 51 placebo-treated patients. Statistically significant differences between flumazenil and placebo were also observed at the 15-minute assessment. Thereafter there were no significant differences between the two treatment groups. Most (70{\%}) flumazenil-treated patients exhibited no recurrence of sedation during the 180 minute assessment period. The most frequent adverse reaction in the flumazenil group was dizziness (6{\%}). 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.",
author = "Bloom, {John W} and Chernik, {D. A.} and Davidson, {A. B.} and Dionne, {R. A.} and Ghoneim, {M. M.} and J. Goff and Keller, {R. T.} and Mora, {C. T.} and C. Pablo and Siegel, {J. L.}",
year = "1992",
language = "English (US)",
volume = "14",
pages = "895--909",
journal = "Clinical Therapeutics",
issn = "0149-2918",
publisher = "Excerpta Medica",
number = "6",

}

TY - JOUR

T1 - Reversal of central benzodiazepine effects by flumazenil after conscious sedation produced by intravenous diazepam

AU - Bloom, John W

AU - Chernik, D. A.

AU - Davidson, A. B.

AU - Dionne, R. A.

AU - Ghoneim, M. M.

AU - Goff, J.

AU - Keller, R. T.

AU - Mora, C. T.

AU - Pablo, C.

AU - Siegel, J. L.

PY - 1992

Y1 - 1992

N2 - 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. A global evaluation of effectiveness was made at the 5-minute assessment, and memory was assessed at the 180-minute assessment. Flumazenil (mean dose: 0.73 mg [7.3 ml]) was significantly more effective than placebo (mean dose: 8.9 ml) in reversing sedation, psychomotor impairment, and amnesia within 5 minutes after the start of administration. At the 5 minute posttreatment assessment, 84% of 102 flumazenil-treated patients (compared with 42% of 52 placebo-treated patients) experienced complete reversal of sedation. Ninety-two percent of 93 flumazenil-treated patients (compared with 41% of 46 placebo-treated patients) had normal psychomotor function. Reversal of amnesia at the 5-minute assessment was achieved in 75% of 101 flumazenil-treated patients and in 20% of 51 placebo-treated patients. Statistically significant differences between flumazenil and placebo were also observed at the 15-minute assessment. Thereafter there were no significant differences between the two treatment groups. Most (70%) flumazenil-treated patients exhibited no recurrence of sedation during the 180 minute assessment period. The most frequent adverse reaction in the flumazenil group was dizziness (6%). 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.

AB - 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. A global evaluation of effectiveness was made at the 5-minute assessment, and memory was assessed at the 180-minute assessment. Flumazenil (mean dose: 0.73 mg [7.3 ml]) was significantly more effective than placebo (mean dose: 8.9 ml) in reversing sedation, psychomotor impairment, and amnesia within 5 minutes after the start of administration. At the 5 minute posttreatment assessment, 84% of 102 flumazenil-treated patients (compared with 42% of 52 placebo-treated patients) experienced complete reversal of sedation. Ninety-two percent of 93 flumazenil-treated patients (compared with 41% of 46 placebo-treated patients) had normal psychomotor function. Reversal of amnesia at the 5-minute assessment was achieved in 75% of 101 flumazenil-treated patients and in 20% of 51 placebo-treated patients. Statistically significant differences between flumazenil and placebo were also observed at the 15-minute assessment. Thereafter there were no significant differences between the two treatment groups. Most (70%) flumazenil-treated patients exhibited no recurrence of sedation during the 180 minute assessment period. The most frequent adverse reaction in the flumazenil group was dizziness (6%). 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.

UR - http://www.scopus.com/inward/record.url?scp=0027048441&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0027048441&partnerID=8YFLogxK

M3 - Article

VL - 14

SP - 895

EP - 909

JO - Clinical Therapeutics

JF - Clinical Therapeutics

SN - 0149-2918

IS - 6

ER -