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临床试验/NCT02443220
NCT02443220已完成不适用

Effects of Regional and Distant Combination of Acupoints Stimulated With Electroacupuncture on Patients Undergoing Off-pump Coronary Artery Bypass Grafting

Xijing Hospital1 个研究点 分布在 1 个国家目标入组 315 人开始时间: 2017年10月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
315
试验地点
1
主要终点
Dosage of sufentanil used during anesthesia

研究概览

简要总结

A prospective, multiple-center, double-blinded, randomized, controlled clinical study to evaluate the antalgic effects between distal-proximal acupoints combination and regional acupoints combination stimulated with electroacupuncture on patients undergoing Off-Pump Coronary-Artery Bypass Grafting(OP-CABG).This clinical trial is to investigate whether electroacupuncture(EA) anesthesia can reduce analgesic in OP-CABG surgery in distal-proximal group.The origins of therapeutic acupuncture can be traced back at least 2,500 years in China. There has been an explosion of interest in Western medicine within the United States and Europe in application of acupuncture technique. Acupuncture enjoys worldwide acceptance for treating diseases such as migraine, chronic low back pain, and knee osteoarthritis. In 2002, WHO recommended 107 symptoms, syndromes, and diseases definitively shown to be effectively treated by acupuncture. Coronary heart disease (angina pectoris) is among these pathologies. A recent clinical trial demonstrated an acupuncture-assisted anesthesia strategy reduces postoperative morbidity and medical costs in open-heart surgery under cardiopulmonary bypass. Previous researches in animal models have demonstrated that electroacupuncture pretreatment protects the heart from ischemic injury. The investigators observed that electroacupuncture pretreatment (EAP, 30-minute electric stimulation through 4 electrodes attached to the bilateral forearm acupoints) before surgery significantly attenuated serum troponin levels during and shortly post-surgery in adult heart valve replacement patients and children undergoing cardiac surgery correcting congenital heart malformation.However, whether electroacupuncture anesthesia may reduce analgesic in OP-CABG surgery,especially in different combination of acupoints,has never been previously investigated.

详细描述

The anesthesia will be performed in a standard way. The propofol and sufentanil will be infused in target-controlled infusion mode. The dosage of analgesic will be assessed by the consumption of sufentanil. And the electroacupuncture anesthesia will be implemented by a device named "Hua Tuo" electronic acupuncture treatment instrument.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •American Society of Anesthesiologists I-III
  • •Scheduled for Off-Pump Coronary-Artery Bypass Grafting surgery
  • •First thoracotomy
  • •Signed written informed consent obtained

排除标准

  • •American Society of Anesthesiologists IV
  • •Undergoing surgery within 12 h of admission to hospital
  • •Life expectancy < 1 year at the time of enrollment
  • •Hemodynamic instability as defined by a systolic blood pressure <90 mmHg
  • •Preoperative Intra-aortic Balloon Pumping or Ventricular Assisted Device
  • •Severe hepatic or renal dysfunction
  • •Not the first thoracotomy
  • •Mediastinal fiber thickening or severe pleural adhesions
  • •Severe adverse reactions
  • •Severe systemic infection
  • •With contraindications to the use of electroacupuncture, such as skin damage or infection at the acupoints
  • •Suffering from nervous system disease or abnormal mental state
  • •Participate in the other clinical trial 3 month before the enrollment

研究组 & 干预措施

distal-proximal group

Experimental

TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Hegu"

干预措施: TEAS (transcutaneous electric acupoint stimulation) (Device)

regional group

Active Comparator

TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Juque"

干预措施: TEAS (Device)

control group

Sham Comparator

no TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Hegu" .

干预措施: TEAS (Device)

结局指标

主要结局

Dosage of sufentanil used during anesthesia

时间窗: during the anesthesia

Dosage of sufentanil used during anesthesia

次要结局

  • Incidence of overall complication(at 1 year)
  • Incidence of overall mortality(at 1 year)
  • Bispectral index during the anesthesia(during the anesthesia)
  • Evaluation of inotropic scores(24h postoperatively)
  • Dosage of propofol used during anesthesia(During the anesthesia)
  • Time of mechanical ventilation(at 30 days)
  • Heart rate during the anesthesia(during the anesthesia)
  • Mean arterial pressure during the anesthesia(during the anesthesia)
  • In-hospital stay(at 30 days)
  • The length of CCU stay(at 30 days)
  • Incidence of overall complication(at 30 days)
  • Incidence of overall mortality(at 30 days)

研究者

发起方
Xijing Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chong Lei, MD & phD

MD& PhD

Xijing Hospital

研究点 (1)

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