Effect of Electroacupuncture on the Incidence of Postoperative Delirium in Elderly Patients Undergoing the Major Surgery：a Prospective, Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- The incidence of delirium within 5 days after surgery
研究概览
简要总结
- Title: Effect of electroacupuncture on the incidence of postoperative delirium in elderly patients undergoing the major surgery.
- Research center: Multicenter
- The Design of the study: Randomized, double-blind, controlled study
- The population of the study: Elderly patients（65≤age<90 years），it is planned to select a period/time limit for gastrointestinal tumor surgery, bile duct surgery, thoracic surgery or orthopedic surgery and so on under general anesthesia, and the estimated operation time≥ 2 hours.
- Sample size: Enroll 1100 patients (550 patients in each group)
- Interventions: Participants in the treatment group received acupuncture (0.30mm×70mm) at bilaterally Shenmen (HT7) acupoints (0.3-0.5 inch), Neiguan (PC6) acupoints (0.5-1 inch), Baihui (DU20) acupoint (0.5-0.8 inch) and Yintang (EX-HN3) acupoint (0.3-0.5 inch) 30 minutes before anesthesia induction. After "Deqi", electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) is connected and maintained the end of operation. Participants in the control group received shallow needling (0.30mm×25mm) at bilateral sham HT7, PC6, DU20 and EX-HN3 (nonacupoints located 1 inch beside acupoints, about 20mm). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no "Deqi" without actual current output.
- The aim of the research: To investigate the effect of electroacupuncture on the incidence of postoperative delirium within 5 days in elderly patients undergoing the major surgery.
- Outcome： 1) Primary outcome：The incidence of delirium within 5 days after surgery； 2) Secondary outcome：The effects on postoperative NRS pain and sleep quality scores；Length of stay in hospital after surgery; Incidence of postoperative complications (including re-hospitalization); 30-day life quality and cognitive function after surgery; All-cause 30-day mortality after surgery.
- The estimated duration of the study：5 years.
详细描述
This study is a multicenter, randomized, double-blinded, placebo-controlled design. In this study, bilateral Shenmen, Neiguan, Baihui and Yintang acupoints were selected for perioperative electroacupuncture treatment, accompanied with evaluating the incidence of delirium within 5 days after surgery and the effects on postoperative NRS pain and sleep quality scores. To clarify the effect of electroacupuncture on the incidence of postoperative delirium in elderly patients undergoing the major surgery is of great significance to the clinical applications and popularization of traditional acupuncture treatment perioperatively across the world.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥65 and <90 years old；
- •Planning to undergo select timed/limited surgery such as gastrointestinal tumor surgery, bile duct surgery and thoracic surgery etc under general anesthesia, and the estimated operation time is more than 2 hours;；
- •Treatment without radiotherapy or chemotherapy prior to surgery；
- •Agree to participate in this study and sign informed consent；
排除标准
- •Refuse to participate in this study；
- •Preoperative history of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis；
- •Inability to communicate in the preoperative period to complete preoperative evaluation because of severe dementia, coma, language barrier；
- •Brain injury or neurosurgery；
- •Critical condition (if the ASA grade is greater than or equal to grade IV before surgery); Severe renal impairment (dialysis treatment before surgery); Severe liver function impairment (Child-Pugh level C); Preoperative combined with severe heart disease, LVEF < 30%;
- •Previous experience of acupoint stimulation therapy or non-insensitive to acupoint stimulation；
- •The attending physician or researcher considers that there are other circumstances (reasons to be noted) that are not suitable for participation in this study.
研究组 & 干预措施
electroacupuncture treatment
Participants in the treatment group received acupuncture (0.30mm×70mm) at bilaterally Shenmen (HT7) acupoints (0.3-0.5 inch), Neiguan (PC6) acupoints (0.5-1 inch), Baihui (DU20) acupoint (0.5-0.8 inch) and Yintang (EX-HN3) acupoint (0.3-0.5 inch) 30 minutes before anesthesia induction. After "Deqi", electroacupuncture stimulation apparatus (Hwato, DSZ-III, Suzhou Medical Supplies Factory Co. LTD) is connected and maintained the end of operation.
干预措施: electroacupuncture treatment (Device)
sham electroacupuncture treatment
Participants in the control group received shallow needling (0.30mm×25mm) at bilateral sham HT7, PC6, DU20 and EX-HN3 (nonacupoints located 1 inch beside acupoints, about 20mm). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no "Deqi" without actual current output.
干预措施: sham electroacupuncture treatment (Device)
结局指标
主要结局
The incidence of delirium within 5 days after surgery
时间窗: preoperative and the first 5 consecutive days after surgery
Using confusion assessment method (CAM) or CAM-ICU methods to assess delirium
次要结局
- The effects on postoperative pain scores(preoperative and the first 5 consecutive days after surgery)
- The effects on postoperative sleep quality scores(preoperative and the first 5 consecutive days after surgery.)
- Length of stay in hospital after surgery(From the end of surgery to hospital discharge, assessed up to 30 days after surgery.)
- Incidence of non-delirium complications during the first 30 days after surgery (including re-hospitalization)(From the end of surgery through postoperative day 30.)
- All-cause 30-day mortality after surgery(From the end of surgery through postoperative day 30.)
研究者
Jianbo Yu
Department of Anesthesiology and Critical Care Medicine, Director, Chief physician, Professor, Doctoral tutor
Tianjin Nankai Hospital