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
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
- 否
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
flumazenil is given
干预措施: Flumazenil (Drug)
control with acupuncture
control with acupuncture
干预措施: Acupuncture (Procedure)
control with acupuncture and flumazenil
control with acupuncture and flumazenil
干预措施: Flumazenil (Drug)
control with acupuncture and flumazenil
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
Dr. Yin Liu
Associate Professor, Chief of Clinical Research
Sichuan Cancer Hospital and Research Institute
