Effect of Flumazenil on Recovery From General Anesthesia With Isoflurane

NCT02157428 | Completed

• 1 other identifier: 984/10
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Effect of Other General Anesthetics

Outcome Measures

Primary Outcomes (1)

• Time of recovery from a general anesthesia isoflurane based

  up to 8 hours

Study Arms (2)

saline

PLACEBO COMPARATOR

patients received 20 ml of saline during 1 minute, after end of surgery.

Drug: saline

flumazenil

ACTIVE COMPARATOR

patients received 1 mg of flumazenil, after end of surgery

Drug: Flumazenil

Interventions

Flumazenil DRUG

flumazenil

saline DRUG

saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital Universitário USP

São Paulo, São Paulo, 05508-000, Brazil

Location

MeSH Terms

Interventions

Flumazenil; Sodium Chloride

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 1, 2014
• First Posted: June 6, 2014
• Study Start: January 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: June 6, 2014

Record last verified: 2014-06

Locations

BR (1)