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临床试验/NCT02157428
NCT02157428已完成不适用

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

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Time of recovery from a general anesthesia isoflurane based

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

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

研究组 & 干预措施

saline

Placebo Comparator

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

干预措施: saline (Drug)

flumazenil

Active Comparator

patients received 1 mg of flumazenil, after end of surgery

干预措施: Flumazenil (Drug)

结局指标

主要结局

Time of recovery from a general anesthesia isoflurane based

时间窗: up to 8 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Domingos Dias Cicarelli, MD, PhD

MD, PhD

University of Sao Paulo

研究点 (1)

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