Postoperative Delirium and Its Biomarkers in Elderly Patients Undergoing Non-cardiac and Non-neurosurgery: a Prospective Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 417
- 试验地点
- 1
- 主要终点
- The incidence of postoperative delirium within postoperative 5 days
研究概览
简要总结
Postoperative delirium (POD) is a common complication in elderly patients and is associated with negative clinical outcomes, such as prolonged hospitalizations, cognitive impairment, and higher mortality rate. While the pathophysiology of delirium remains unknown, the cerebral hypoperfusion and neuroinflammatory response are considered to play an important role in the process of POD. The aim of the study is to determine the association between POD and biomarkers in elderly patients undergoing noncardiac and non-neurological 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
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With American Society of Anesthesiologists (ASA) physical status Ⅱ-Ⅳ
- •Undergo elective non-cardiac and non-neurological surgery receiving general anesthesia
- •Operation time is expected to be longer than 2 hours
排除标准
- •Clinical diagnosis of dementia
- •Clinical diagnosis of cerebrovascular disorders
- •Clinical diagnosis of heart failure
- •Clinical diagnosis of liver failure
- •Clinical diagnosis of renal failure
- •Clinical diagnosis of traumatic brain injury
- •Alcohol abuse
- •Can not complete the cognitive assessments
- •Refuse to sign informed consent
结局指标
主要结局
The incidence of postoperative delirium within postoperative 5 days
时间窗: the incidence of delirum within postoperative 5 days.
The postoperative delirium will be diagnosed if patients have fluctuation in mental status and attention and either thinking or consciousness in the past 24 hours as evidenced by fluctuation on Confusion Assessment Method-Intensive Care Unit (CAM-ICU) scale.
次要结局
未报告次要终点
研究者
Ruquan Han
Professor
Beijing Tiantan Hospital