Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Delirium and EEG Characteristic Parameters in Elderly Patients Undergoing Abdominal Surgery Under General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Incidence of delirium by 7 days after surgery
研究概览
简要总结
Transcutaneous electrical acupoint stimulation (TEAS) was reported to benefit the patients undergoing surgeries by reducing anesthetics consumption and decreasing anesthesia related adverse effects. Electroencephalogram (EEG) and EEG-related indicators are important indicators reflecting the conscious state of the brain, and different anesthetic drugs and anesthesia depths cause different EEG characteristic changes. The mechanism by which TEAS improves postoperative delirium (POD) is not clear, and whether changes in EEG characteristic parameters is involved needs to be further explored. Therefore, this study aims to observe the effect of TEAS at Neiguan and Shenmen acupoint on POD in elderly patients undergoing abdominal surgery, and to explore the EEG related mechanism underlying TEAS improving POD.
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)
盲法说明
Four or six patients were defined as a block group and the results were sealed in envelopes using computer-generated block randomisation by a researcher not involved in clinical anesthesia. After the patients were enrolled, the study nurse opened the envelope according to the corresponding enrollment number and obtained the group results.
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
- •aged 65 years or older
- •American Society of Anesthesiologists (ASA) classification≤ Grade III
- •Patients scheduled for elective abdominal surgery under general anesthesia
- •Informed consent
排除标准
- •Patients with severe central nervous system injury or severe cerebrovascular disease
- •Patients with cognitive dysfunction assessed by Confusion Assessment Method before surgery
- •Patients unable to cooperate with studies, such as psychiatric disorders or difficulty in communication
- •Patients with severe hepatic and renal insufficiency
- •Patients with severe respiratory diseases
- •Patients with contraindication for transcutaneous electrical stimulation, such as implanted electrophysiological devices, skin infection and damage at acupuncture points
- •Anticipated duration of anesthesia shorter than 2 hours or postoperative hospital stay shorter than 3 days
研究组 & 干预措施
Transcutaneous electrical stimulation
At the beginning of anesthesia induction, the electrodes are attached to the skin at the Neiguan point and Shenmen point and connected to the percutaneous acupoint electrical stimulation device (Hwato , Suzhou Medical Equipment Factory). Electrical stimulation is given.
干预措施: transcutaneous electrical acupoint stimulation (Other)
Control
At the beginning of anesthesia induction, the electrodes are attached to the skin at the Neiguan point and the Shenmen point without stimulation
干预措施: Control (Other)
结局指标
主要结局
Incidence of delirium by 7 days after surgery
时间窗: from end of surgery to 7 days after surgery
Delirium will be assessed by 3-minute Diagnostic Interview for Confusion Assessment Method
次要结局
- Incidence of delirium by 1 day after surgery(From end of surgery to 1 day after surgery)
- Maximal decrease of regional cerebral oxygen saturation(From anesthesia induction to the end of surgery)
- Incidence of delirium by 3 days after surgery(From end of surgery to 3 days after surgery)
- electroencephalogram (EEG) alpha band power(From anesthesia induction to the end of surgery)
- opioid consumption for patient controlled analgesia(From end of surgery to 1 day after surgery)
- Incidence of major complications(From end of surgery to discharge from hospital, at an average of 7 days)
- The numerical rating scale of sleep quality(From end of surgery to 1 day after surgery)
- The numerical rating scale of pain(From end of surgery to 1 day after surgery)
- The numerical rating scale of sleep quality(From end of surgery to 3 days after surgery)
- The numerical rating scale of pain(From end of surgery to 3 days after surgery)
- The Quality of Recovery-15 Score by 3 days after surgery(From end of surgery to 3 days after surgery)
- number of attempts for patient controlled analgesia(From end of surgery to 1 day after surgery)
- total sleep time(From end of surgery to 1 day after surgery)
研究者
Zhihong LU
Associate professor
Air Force Military Medical University, China