Effect of Transcutaneous Acupoint Electrical Acupoint Stimulation Combined With Auricular Acupressure on Postoperative Delirium in Elderly Patients Undergoing Major Abdominal Surgery: a Pragmatic Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Incidence of delirium
研究概览
简要总结
Postoperative delirium is with increased incidence in elderly patients. Previous studies have shown that acupuncture related techniques could induce protection against brain ischemia and improve outcome after cerebral diseases. In this study the effect of transcutaneous electrical acupoint stimulation combined with auricular acupressure on postoperative delirium will be evaluated.
详细描述
Postoperative delirium (POD) is an acute neurological disorder that commonly happens between postoperative days 1 and 3 and more common reported in elderly patients. The rate of delirium differs depending on the patients' characteristics, surgery types and setting of health care. The prevalence of delirium range from 18% to 35 % in a general medical service, and up to half of older patients postoperatively. It has been documented that POD is associated with an increase in mortality and morbidity, increased use of hospital resources, and higher cost of health care. The conventional preventive methods for delirium have focused on minimization or elimination of the predisposing and precipitating factors. Yet, few effective therapies are available for treating POD. New treatments are needed to reduce the prevalence and severity of delirium.
Complementary therapies, particularly acupuncture, have gained increasing attention for their possible value in the prevention and treatment of neurological disorders. Both basic and clinical studies have suggested that acupuncture may be beneficial to postoperative delirium. In functional MRI studies of healthy subjects and nervous system dysfunction patients, acupuncture has been shown to stimulate hippocampus, amygdala and insula, areas of the brain associated with memory, cognition and emotion.
In the clinical, TEAS has been reported to be effective in alleviating delirium in elderly patients with silent lacunar infarction. Evidence also showed that auricular acupunctures are efficacious for preventing postoperative agitation in geriatric patients
Given evidences of the possible efficacy of TEAS and auricular acupressure, we aim to do a 2-arm, randomized, controlled, single-blinded, pragmatic trial to investigate whether transcutaneous electrical acupoint stimulation combined with auricular acupressure is more effective in reducing postoperative delirium in elderly patients than usual care.
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 (Care Provider, Outcomes Assessor)
盲法说明
transcutaneous electrical acupoint stimulation and auricular acupressure is given by an investigator who is not involved in anesthesia and outcome assessment
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective abdominal surgery under general anesthesia
- •American Society of Anesthesiologists (ASA) physical status class≤Ⅲ;
- •Mini mental state examination (MMSE) score>20;
排除标准
- •Implantation of a cardiac pacemaker, cardioverter, defibrillator or internal hearing aids;
- •Documented alcohol or substance abuse within 3 months before surgery;
- •Dermatological conditions or frail skin;
- •Dysesthesia or infection over the acupoint stimulation skin area;
- •Limb abnormalities;
- •Allergy to ECG pads;
- •Use of psychoactive medications;
- •Severe visual or auditory impairment;
- •Preoperative history of schizophrenia, epilepsy, parkinsonism, depression, or myasthenia gravis;
- •Brain injury or neurosurgery.
结局指标
主要结局
Incidence of delirium
时间窗: From the end of surgery to 7 days after surgery
In postoperative 7 days or during patients stay in hospital if discharged within 7 days
The severity of delirium
时间窗: From the end of surgery to 7 days after surgery or during patients stay in hospital if discharged within 7 days
Assessed by memorial delirium assessment scale (MDAS)
次要结局
- Postoperative pain(24h, 48h, 72h after surgery)
- Tumor necrosis factor-α level(Before surgery and at the end of the surgery)
- S100B level(Before surgery and at the end of the surgery)
- Postoperative sleep qualiy(4 days after surgery)
- Length of stay in hospital after sugery(From the day of suregry to discharge from surgery)
- Matrix metalloproteinase 9 level(Before surgery and at the end of the surgery)
- Neuron-specific enolase level(Before surgery and at the end of the surgery)
- Brain-derived neurotrophic factor level(Before surgery and at the end of the surgery)
- Aquaporin-4 level(Before surgery and at the end of the surgery)
- Interleukin-10 level(Before surgery and at the end of the surgery)
- Interleukin- 6 level(Before surgery and at the end of the surgery)
- Tau protain level(Before surgery and at the end of the surgery)
- β-Amyloid1-42 level(Before surgery and at the end of the surgery)
研究者
Zhihong LU
principle investigator
Air Force Military Medical University, China