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临床试验/NCT02690389
NCT02690389已完成不适用

The Sedation Effect of Electro-acupuncture on Bilateral Zusanli (ST 36) and Neiguan (PC 6) in General Anesthesia May Not be Mediated by the Benzodiazepines- GABA Pathway

Dr. Yin Liu1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015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
发起方
入组人数
80
试验地点
1
主要终点
depth of general anaesthesia

研究概览

简要总结

Object: To explore the mechanism of the electro-acupuncture (EA) induced sedation effect in general anaesthesia through investigating the role of the Benzodiazepines-GABA system.

Method: 80 patients undergoing abdominal surgery were randomly divided into four groups (n=20): C group (propofol only group), F group (propofol + flumazenil group), EA group (propofol + electro-acupuncture group), and EA+F group (propofol + electro-acupuncture + flumazenil group). Before induction, acupuncture needles were inserted at the points of Zusanli (ST 36) and Neiguan (PC 6) bilaterally to elicit"DeQi". Target-controlled infusion (TCI) of propofol was used for the induction and maintenance of anaesthesia. After 15minutes, equilibrium of Narcotrend Index (NT index) was achieved, patients were then assigned to receive different interventions. In EA group and EA+F group, patients received EA for 30 minutes under general anaesthesia, and flumazenil with the dosage of 0.1mg/kg was added in the latter at the end of EA. In C group and F group, patients didn't receive EA, and flumazenil with the dosage of 0.1mg/kg was administered in F Group at the same time point with EA+F group. HR, MAP and NT index were recorded at different time points up to 30 minutes after the end of EA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 80 abdominal surgical patients
  • aged 30 to 60 years old,
  • weighing 50-70Kg,
  • ASA I-Ⅱ, who scheduled to receive general anaesthesia were enrolled to this trial.

排除标准

  • Hypertension or severe heart and lung diseases,
  • Conditions that might affect the consciousness or NT index, such as seizures, psychosis, brain lesions, and treatment with sedative drugs,
  • Contraindications to acupuncture, such as severe hemorrhagic disease, hyper-sensitive patient, and tumor or ulcer exist on the skin of the acupuncture points.

研究组 & 干预措施

Flumazenil only group

Sham Comparator

flumazenil is given

干预措施: Flumazenil (Drug)

control with acupuncture

Active Comparator

control with acupuncture

干预措施: Acupuncture (Procedure)

control with acupuncture and flumazenil

Active Comparator

control with acupuncture and flumazenil

干预措施: Flumazenil (Drug)

control with acupuncture and flumazenil

Active Comparator

control with acupuncture and flumazenil

干预措施: Acupuncture (Procedure)

结局指标

主要结局

depth of general anaesthesia

时间窗: 2 hours

次要结局

未报告次要终点

研究者

发起方
Dr. Yin Liu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Yin Liu

Associate Professor, Chief of Clinical Research

Sichuan Cancer Hospital and Research Institute

研究点 (1)

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