Association of the Exercise-Irisin-EEG Cascade With Intrinsic Brain Vulnerability and Its Impact on Postoperative Delirium in Elderly Patients: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Postoperative Delirium
研究概览
简要总结
The goal of this observational study is to learn how exercise-induced irisin protects the brain. It also explores irisin's effect on postoperative delirium (POD) in older adults. The main questions it aims to answer are:
Does daily activity link to POD? Does irisin play a mediating role in this process? Researchers will enroll active and inactive adults aged 65 and older. All will have surgery under spinal anesthesia. The researchers will measure irisin levels in spinal fluid. They will track POD and other complications for five days after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 65 years;
- •Classified as ASA physical status I to III;
- •Scheduled for non-cardiovascular surgery under spinal anesthesia or combined spinal-epidural anesthesia;
- •Expected surgical duration of at least 2 hours;
- •Voluntarily provide written informed consent and agree to participate in this study.
排除标准
- •Significant change in exercise status within the past 7 days due to injury or other reasons;
- •Contraindications to neuraxial anesthesia;
- •Unable to assess cognitive function or Montreal Cognitive Assessment (MoCA) score < 23;
- •Preoperative diagnosis of delirium;
- •History of traumatic brain injury or neurosurgery;
- •Long-term opioid use or history of alcohol abuse;
- •Planned surgery cancelled or changed (including intraoperative events that significantly alter the procedure or duration);
- •Change in anesthesia method.
研究组 & 干预措施
Insufficient Daily Exercise
The participants with a PASE score less than 104 were classified as the group with insufficient daily physical activity.
干预措施: Preoperative physical activity level (Behavioral)
Regular Daily Exercise
The participants with a PASE score of 104 or above are classified as the group with regular daily physical activity
干预措施: Preoperative physical activity level (Behavioral)
结局指标
主要结局
Postoperative Delirium
时间窗: five days after surgery
Delirium will be assessed using the CAM or CAM-ICU (for patients in the ICU) by researchers twice daily. For patients who develop POD, the severity of POD will be evaluated using the Delirium Rating Scale-Revised-98 (DRS-R-98).
次要结局
未报告次要终点
研究者
Yi Feng, MD
Chair of Department of Anesthesiology
Peking University People's Hospital