Hospital Universitário USP
São Paulo, 05508-000, Brazil
NCT Number: NCT02157428
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.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Not applicable
São Paulo, 05508-000, Brazil
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: up to 8 hours
University of Sao Paulo
Other
Effect of Flumazenil on Recovery From General Anesthesia With Isoflurane: a Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01812915
Adverse Effect of Other General Anesthetics, Anesthesia Intubation Complication
Goyang, Gyeonggido, South Korea
View Trial DetailsNCT02486926
Adverse Effect of Other General Anesthetics
View Trial Details