The Effect of 40 Hz Transcranial Stimulation on the Incidence of Delirium After Total Hip Replacement or Total Knee Replacement Arthroplasty in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- The incidence of postoperative delirium
研究概览
简要总结
Delirium is an acute confusional state, it is a sign of acute encephalopathy, also known as acute brain failure, acute brain dysfunction or mental state changes.Postoperative delirium can cause post-traumatic stress disorder, affects patients' quality of life, extend the length of hospital stay, increased hospitalization cost, and is closely relative to short-term and long-term mortality after surgery. Exogenous 40 Hz stimulation can improve cognitive functioning. Therefore, the aim of this study was to investigate the effect of exogenous 40Hz stimulation on the incidence of postoperative delirium in elderly patients undergoing hip and knee replacement.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.65-85 years old, gender not limited 2.General anesthesia unilateral total hip replacement surgery or unilateral total knee replacement 3.ASA classification I-III 4.No drugs for mental and central nervous system diseases were used before surgery 5.Preoperative MMSE score illiterate > 17 points, primary > 20 points, junior high school and above > 24 points 6.Obtaining informed consent
排除标准
- •Severe liver and kidney dysfunction
- •here were mental and nervous system diseases before operation
- •Have a history of alcoholism, long-term use of sedative or analgesic
- •A history of a delirium and other reasons are reluctant to cooperate
- •Massive blood loss and blood transfusion during operation, prolonged operation time
结局指标
主要结局
The incidence of postoperative delirium
时间窗: Day 1, Day 2, Day 3 after surgery
Postoperative delirium was assessed by CAM scale.The diagnosis of delirium mainly depends on four characteristics: 1 acute fluctuating course; 2 attention disorder; 3 thinking disorder; 4 change of consciousness level. At the same time, 1 and 2, and 3 or 4 can be used to diagnose delirium.
次要结局
- Blood Markers(Preoperative and postoperative 1 d and 2 d)
- The incidence of postoperative nausea and vomiting(Day 1, Day 2, Day 3 after surgery)
- Sleep quality(Day 1, day 2, day 3 after surgery)
- The incidence of pain(Day 1, day 2, day 3 after surgery)