Effects of Regional and Distant Combination of Acupoints Stimulated With Electroacupuncture on Patients Undergoing Off-pump Coronary Artery Bypass Grafting
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
TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Hegu"
干预措施: TEAS (transcutaneous electric acupoint stimulation) (Device)
regional group
TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Juque"
干预措施: TEAS (Device)
control group
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
Chong Lei, MD & phD
MD& PhD
Xijing Hospital
