Perioperative Transcutaneous Electrical Acupoint Stimulation for Enhanced Recovery After Laparoscopic Colon Surgery:a Multi-center Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Time to meeting discharge criteria
研究概览
简要总结
The purpose of this study is to observe the effects of transcutaneous electrical acupoint stimulation(TEAS) on postoperative recovery after laparoscopic colon surgery.
详细描述
Patients were randomly assigned to two groups, receiving TEAS andno stimulation respectively. Interventions were given 30min before anesthesia and 1, 2 , 3 day after surgery, lasted 30min each time . The acupoints of TEAS group are bilateral ST36/SP6 combined with PC6/LI4, and the control group only attach electrodes without electric current. The frequency of TEAS is set to 2/10 Hz. After surgery, the time of meeting discharge criteria, first flatus and defecation were recorded. Score of PONV, life quality, sleep quality and VAS of pain were evaluated 24, 48 and 72h after surgery. The postoperative complications, re-exploration, cost of hospitalization and adverse events were also recorded.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Inventions were given by an investigator who is not involved in patient care. The anesthetists, surgeons,staff in the ward, the one who record the outcomes, and data analyzer were all blinded to the group allocation.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 to 75 years old；
- •ASA I-III；
- •Scheduled for elective laparoscopic colon surgery under general anesthesia；
- •BMI between 18 and 30；
- •Informed consented.
排除标准
- •Patients with contraindications to the use of electroacupuncture, such as skin damage or infection at the acupoints；
- •Patients with difficulty in communication；
- •Emergency surgery；
- •Patients who are with distant metastasis;
- •Patients who are with history of myocardial infarction or cerebral infarction in the past six months；
- •Patients who are with long history of taking NSAIDS，hormone or immunosuppressive agents；
- •Patients who are recruited in other clinical trials in the last 3 months；
- •Other situations researcher think shouldn't be included.
研究组 & 干预措施
TEAS
Patients were given 30min of TEAS(transcutaneous electrical acupoint stimulation) before anesthesia and 1,2,3 day after surgery
干预措施: TEAS (Other)
false stimulation
Attach electrodes without electric current
干预措施: false stimulation (Other)
结局指标
主要结局
Time to meeting discharge criteria
时间窗: end of the surgery to discharge,with an average of 7 days
次要结局
- Time to first flatus(end of the surgery to discharge,with an average of 7 days)
- Time to first defecation(end of the surgery to discharge,with an average of 7 days)
- Incidence of postoperative complications(end of the surgery to discharge,with an average of 7 days)
- Time to first oral intake of water(end of the surgery to discharge,with an average of 7 days)
- quality of sleeping score(end of surgery to 24 hours, 48 hours, and 72 hours after surgery)
- quality of recovery(end of surgery to 24 hours, 48 hours, and 72 hours after surgery)
- visual analogue scale(end of surgery to 24 hours, 48 hours, and 72 hours after surgery)
- incidence of nausea and vomiting(end of surgery to 24 hours, 48 hours, and 72 hours after surgery)
- expense(end of the surgery to discharge,with an average of 7 days)
研究者
Zhihong LU
Doctor
Air Force Military Medical University, China