Effect of Flumazenil on Recovery From General Anesthesia With Isoflurane

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Flumazenil on Recovery From General Anesthesia With Isoflurane: a Randomized Controlled Trial

Conditions
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Adverse Effect of Other General Anesthetics

Intervention / Treatment
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* Drug: Flumazenil
* Drug: saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: saline<br>patients received 20 ml of saline during 1 minute, after end of surgery. | Drug: saline<br> <br> |
| Active Comparator: flumazenil<br>patients received 1 mg of flumazenil, after end of surgery | Drug: Flumazenil<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of recovery from a general anesthesia isoflurane based |  | up to 8 hours |