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临床试验/NCT02597530
NCT02597530Unknown不适用

Effect of Different Time of Transcutaneous Electric Acupoint Stimulation(TEAS) on Acupuncture Anesthesia

wangqiang0 个研究点目标入组 60 人开始时间: 2015年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
主要终点
Consumption of remifentanil during the operation(ug/kg/min).

研究概览

简要总结

To determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) combined with general anesthetic during peri-operative could alleviate the dosage of anesthetic drugs compared with control and sham group.

详细描述

Acupuncture is a traditional Chinese medical technique that involves the insertion of needles at acupoints to treat diseases by Jingluo (the system of meridians, through which energy is thought to flow through the body in Chinese medicine). It is usually applied to relieve pain. Several clinical trials have been conducted to evaluate the effect of electroacupuncture on the consumption of intra-operative anaesthetics and on drug-related side-effects, with promising results. Compared with acupuncture or electroacupuncture, transcutaneous electric acupoint stimulation(TEAS) is a non-invasive technique and has some advantages, including no risk of infections or needle-induced contagious disease and reduced fear of stimulation. It can potentially be applied by any anaesthetist or pre-operative personnel with minimal training.Thus, investigators conducted this controlled, prospective, double-blinded clinical trial to investigate whether treating by transcutaneous electrical acupoint stimulation combined with general anesthetic during peri-operative could alleviate the dosage of anesthetic drugs compared with control and sham group.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 18 and 65
  • ASA physical statusⅠorⅡ
  • Elective gynecological laparoscopic surgery under general anesthesia
  • BMI of 18 to 25
  • Duration of operation≤2 hours
  • Patient who signed the informed consent

排除标准

  • Pregnancy or breast-feeding women
  • Serious lung disease/Serious cardiovascular disease/Serious liver, renal abnormalities
  • Patients who have a history of gastrointestinal surgery or chronic gastrointestinal disease
  • Patient has diseases in nervous-mental system
  • Operation time more than 2 hours
  • Patients with contraindications to the use of electroacupuncture, such as skin damage or infection at the acupoints;
  • Patients with experience of transcutaneous electrical stimulation treatment.

结局指标

主要结局

Consumption of remifentanil during the operation(ug/kg/min).

时间窗: intraoperative

次要结局

  • Pain after the operation(visual analog scale (vas)).(0 hours ,2 hours ,12 hours ,24 hours after operation)
  • Content of endocrine hormone in the blood(angiotensin-II(ng/L),Cortisol(nmol/L),β-endorphin(ng/mL) and glucose(mmol/L)).(intraoperative)
  • Side-effects of anesthetics(nausea,vomiting,dizziness and pruritus).(0 hours ,2 hours ,12 hours ,24 hours after operation)
  • Time of extubation after operation.(intraoperative)
  • Hospital stays after operation(d).(Participants will be followed for the duration of hospital stay, an expected average of 4 days)

研究者

发起方
wangqiang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

wangqiang

Professor

Xijing Hospital

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