Effect of Flumazenil on Recovery From General Anesthesia With Isoflurane

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT02157428
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Jan 1, 2011
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Time of recovery from a general anesthesia isoflurane based [up to 8 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitário USP	São Paulo		Brazil	05508-000

Sponsors and Collaborators

• University of Sao Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Domingos Dias Cicarelli, MD, PhD, MD, PhD, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT02157428
• Other Study ID Numbers: 984/10
• First Posted: Jun 6, 2014
• Last Update Posted: Jun 6, 2014
• Last Verified: Jun 1, 2014

• Additional relevant MeSH terms: Flumazenil

Study Results

No Results Posted as of Jun 6, 2014