The Protective Effect of Transcutaneous Electrical Acupoint Stimulation (TEAS) on Aged Patients Undergoing Lower Extremity Arthroplasty: A Single-Center, Double-Blinded, Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 主要终点
- The incidence of postoperative complications
研究概览
简要总结
This is a single center, randomized, double-blinded, controlled clinical trial. The purpose of this study is to to determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) during perioperative could alleviate the postoperative complications in patients undergoing artificial joint replacement surgery.
详细描述
The complications from patients accepted artificial joint replacement surgery will directly or indirectly affect the prognosis of the patients, resulting in patients with delayed recovery and increase the hospitalization time and cost. Serious complications can lead to patients deaths during perioperative period. It has been proved that the electroacupuncture application during perioperative period can reduce the dosage of anesthetic drugs, and has a good effect on the protection of the heart and brain. At the same time, the electroacupuncture can also regulate the body's immune function, reduce allergy, reduce postoperative pain and so on.Compared with acupuncture, transcutaneous electric acupoint stimulation (TEAS) is a noninvasive technique that has similar effects to acupuncture. The investigators hypothesize that TEAS before anesthesia and during surgery would decrease the morbidity and mortality of postoperative complications in 30 days after artificial joint replacement surgery.
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
- 60 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASAⅡ-Ⅲ,elective operation patients
- •No other severe complications history
- •Able to give informed consent
排除标准
- •Having severe comorbidity resulting in estimated life expectancy <1 year.
- •Infection at the electroacupuncture site.
- •Suffered from neurologic disorder or impaired mental state
- •Participate in the other clinical trial 3 months before the enrollment
- •No suitable to participate in this experiment
结局指标
主要结局
The incidence of postoperative complications
时间窗: within 30 days after operation
Participants will be followed for the incidence of postoperative complications
次要结局
- length of postoperative hospital stay(an expected average of 1 week)
- Quality of life during 30 days after surgery(One month)
- ICU transfer rate after operation(One month)
研究者
Zheng Guo
professor
Second Hospital of Shanxi Medical University