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Trial record 7 of 39 for:    FLUMAZENIL

Effect of Flumazenil on Recovery From General Anesthesia With Isoflurane

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ClinicalTrials.gov Identifier: NCT02157428
Recruitment Status : Completed
First Posted : June 6, 2014
Last Update Posted : June 6, 2014
Sponsor:
Information provided by (Responsible Party):
Domingos Dias Cicarelli, MD, PhD, University of Sao Paulo

Brief Summary:
Background and objectives: The inhalational anesthetic isoflurane is widely used in general anesthetics. Its mechanism of action involves interaction with the receptor of gamma-amino butyric acid (GABA), which is also the binding site for benzodiazepines. Flumazenil, benzodiazepine antagonist, reverses the effects of these drugs in GABA receptors and could therefore also reverse the effect of isoflurane. In anesthesia practice, extubation and early anesthetic recovery reduce morbidity and incidence of complications. The objective of this trial is to determine whether the use of flumazenil may contribute to faster recovery from anesthesia. Methods: 40 patients scheduled to undergo general anesthesia with isoflurane were enrolled in this prospective, double-blind, randomized trial. Patients were randomized to receive, at the end of anesthesia, flumazenil or placebo as allocated into two groups. The anesthetic technique was standardized. The groups were compared concerning values of Cerebral State Index (CSI), heart rate, blood pressure and oxygen saturation from the application of flumazenil or placebo until 30 minutes after injection. Data regarding time to extubation, time to reach ten points in the Aldrete-Kroulic score (AK = 10) and Vigilance score (VS = 10) was also collected. ANOVA test was applied to analyze the results, considering p <0.05.

Condition or disease Intervention/treatment Phase
Adverse Effect of Other General Anesthetics Drug: Flumazenil Drug: saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Effect of Flumazenil on Recovery From General Anesthesia With Isoflurane: a Randomized Controlled Trial
Study Start Date : January 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: saline
patients received 20 ml of saline during 1 minute, after end of surgery.
Drug: saline
Active Comparator: flumazenil
patients received 1 mg of flumazenil, after end of surgery
Drug: Flumazenil



Primary Outcome Measures :
  1. Time of recovery from a general anesthesia isoflurane based [ Time Frame: up to 8 hours ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients scheduled to surgeries with general anesthesia,
  • healthy or with minor diseases completely controlled by regular use of medications (ASA I or II according to the classification of physical state by the American Society of Anesthesiologists).

Exclusion Criteria:

  • patients with past of chronic use of benzodiazepines and/or illicit drugs,
  • seizures or panic disorder.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02157428


Locations
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Brazil
Hospital Universitário USP
São Paulo, Brazil, 05508-000
Sponsors and Collaborators
University of Sao Paulo

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Responsible Party: Domingos Dias Cicarelli, MD, PhD, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02157428     History of Changes
Other Study ID Numbers: 984/10
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: June 6, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Flumazenil
Isoflurane
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Inhalation
Anesthetics, General
Antidotes
Protective Agents
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action