Acupuncture-assisted-anesthesia to Improve Complications After Digestive Surgery in Elderly Patients:Multi-center Double-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 748
- 试验地点
- 1
- 主要终点
- Number of Participants with Pulmonary Adverse Events as a Measure of Morbidity Tolerability
研究概览
简要总结
The investigators assume that transcutaneous electric acupoint stimulation (TEAS) pretreatment may activate the endogenous protective mechanism, as a result protect the patients against subsequent surgical stress pregnancy. And TEAS may induce the production of endogenous analgesic transmitters, so develop an anesthetic-sparing effect. The investigators believe this intervention will reduce the subsequent incidence, duration and severity of organ dysfunction, possibly reducing the morbidity, even mortality. So in this study, the investigators hypothesize that TEAS before anesthesia and during surgery would decrease the morbidity and mortality of postoperative complications in 30 days after digestive surgery in elderly patients .
详细描述
Patients older than 65 years old are at higher risk of postoperative morbidity and mortality. With the increasing number of old patients scheduled for digestive surgery, exploring methods to decrease postoperative morbidity is very important. Noninvasive methods may be easier to clinically use. Transcutaneous electric acupoint stimulation (TEAS)has been proved to decrease need for general anesthetics during anesthesia, and to alleviate systemic inflammatory response. Considering the morbidity and mortality after surgery is closely related to use of anesthetics and inflammatory response,TEAS may be a good selection for improving postoperative outcomes.Among the postoperative complications, pulmonary complication and systemic inflammatory response syndrome is with higher incidence, so we will focus on these two complications in our study.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent
- •Age ≥65 years of age
- •Elective digestive surgery under general anesthesia
排除标准
- •ASA(American Society of Anesthesiologists) status> Ⅲ
- •Patients undergoing surgery within 12 h of admission to hospital
- •Patients undergoing surgery of the chest
- •Patients suffered from neurologic disorder or impaired mental state
- •Patients with contraindications to the use of electro-acupuncture, 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
Number of Participants with Pulmonary Adverse Events as a Measure of Morbidity Tolerability
时间窗: participants will be followed from the end of the surgery to 30 days after surgery
次要结局
- Number of participants died of all causes(Participants will be followed from the end of the surgery to 30 days after surgery)
- Number of participants with Systemic Inflammatory Response Syndrome(SIRS)(Participants will be followed from the end of the surgery to 30 days after surgery)
- Number of participants with ICU admission(participants will be followed for the duration of hospital stay after surgery, an expected average of 7 days)
- Length of ICU stay(participants will be followed for the duration of hospital stay after surgery, an expected average of 7 days)
- Length of hospital stay(participants will be followed for the duration of hospital stay after surgery, an expected average of 7days)
研究者
Zhihong LU
Dr.
Air Force Military Medical University, China