Effects of Transcutanclus Electrical Acupoint Stimulation on Postoperative Cognitive Dysfunction in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- the incidence of POCD
研究概览
简要总结
Patients undergoing elective orthopedics, urology, and general surgery will be included and randomly allocated to TEAS group or control group . After routine anesthesia induction and tracheal intubation, patients in TEAS group will receive electrical stimulation of acupoints at Neiguan and Shenmen points. For patients in the control group, the electrodes will be only attached to the corresponding sites, with no TEAS electrical stimulation given during the operation. The primary outcome is the incidence of POCD at Day 7 after surgery. The secondary outcomes include the incidence of POD during post-operative days 1-7, the incidence of POCD at Day 30 after surgery, and the serum levels of cytokines, including IL-1β、IL-6、TNF-α、MMP9 on Day 1 after surgery.
详细描述
This study will enroll 110 patients who are older than 60 years old and will have elective orthopedics, urology, or general surgeries under general anesthesia. Patients will be randomly assigned to TEAS group and control group. After routine anesthesia induction and tracheal intubation, patients in TEAS group will receive electrical stimulation of acupoints at Neiguan and Shenmen points for 30min every hour. In other words, the patients will receive TEAS stimulation for 30min, then no stimulation for 30min, then stimulation for another 30min, etc, until the end of the surgery. For patients in the control group, the electrodes will be only attached to the corresponding sites, with no TEAS electrical stimulation given during the operation. The primary outcome is the incidence of POCD at Day 7 after surgery. The secondary outcomes include the incidence of POD during post-operative days 1-7, the incidence of POCD at Day 30 after surgery, and the serum levels of cytokines, including IL-1β、IL-6、TNF-α、MMP9 on Day 1 after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≧ 60 years old;
- •communicate normally；
- •ASA Physical Status 1-2;
- •Patients will have elective orthopedics, urology or general surgeries under general anesthesia;
- •With an estimated surgery time of more than 2h;
- •Agree to participate the trial.
排除标准
- •Patients with brain diseases or history of brain diseases;
- •Preoperative diagnosis of cognitive impairment by subtle mental state (MMSE) less than 24 points;
- •Patients with history of neurological and psychological disorders including AD, stroke, and psychosis;
- •Severe hearing or visual impairment, illiteracy;
- •preoperative systolic blood pressure >190mmHg, or diastolic blood pressure >100mmHg;
- •Disagree to participate in this research;
- •Have used other medical electronic devices.
研究组 & 干预措施
TEAS group
Patients in the TEAS group will receive electrical stimulation of acupoints at Neiguan and Shenmen points for 30min every hour. The stimulation will repeat until the end of surgery.
干预措施: Transcutaneous electrical acupoint stimulation (Procedure)
control group
In patients from the control group, the electrodes will only be attached to the corresponding sites, with no TEAS electrical stimulation given during the operation.
结局指标
主要结局
the incidence of POCD
时间窗: at Day 7 post-surgery
cognitive function of the patients will be analyzed with MMSE, Digital breadth, Number symbol, Visual regeneration, Color word conversion, Color Trail Marking Test (PartB) and CAM, and reflected by Z score with the following formula: Z=（Xafter-Xbefore）/SDbefore
次要结局
- the incidence of delirium(from Day 1 to Day 7 post-surgery)
- serum IL-1β level(at Day 1 post-surgery)
- serum IL-6 level(at Day 1 post-surgery)
- the incidence of POCD(at Day 30 post-surgery)
- serum TNF-α level(at Day 1 post-surgery)
- serum MMP9 level(at Day 1 post-surgery)