NCT04219033招募中不适用
Correlation Between Postoperative Cognitive Function and EEG Parameters in Elderly Patients Undergoing Non-cardiac Major Surgery : Multi-center, Prospective, Observational Study
Air Force Military Medical University, China18 个研究点 分布在 1 个国家目标入组 1,250 人开始时间: 2020年5月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,250
- 试验地点
- 18
- 主要终点
- The difference of delta wave miss rate between patients with or without cognitive dysfunction by 1 day after surgery
研究概览
简要总结
In the elderly patients undergoing elective non-cardiac major surgery, the differences of EEG parameters between those with and without postoperative cognitive dysfunction were observed to determine the characteristic changes of EEG parameters related to postoperative cognitive dysfunction
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 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 65 and above
- •non-cardiac surgery under general anesthesia;
- •American Society of Anesthesiology(ASA) classification I- II
- •Patients aged 18-40 years old are set as background
排除标准
- •patients with central nervous system diseases and mental diseases
- •preoperative minimal mental status examination(MMSE) score<24;
- •ASA status III or higher
- •those who have received less than 5 years of education since entering primary school; 4) history of sedatives or antidepressants use; 5) existed or anticipated alcohol or drug abuse(over 40°c and over 100ml per day for the past 3 months); 6) history of surgery within the previous year; 7) those with severe visual or hearing impairment; 8) those participated in other clinical studies within last 3 months;
结局指标
主要结局
The difference of delta wave miss rate between patients with or without cognitive dysfunction by 1 day after surgery
时间窗: from end of surgery to 1 day after surgery
The difference (OR) between the miss rate of delta wave in patients with and without cognitive function change 1 day after operation.
The difference of spindle miss rate between patients with or without cognitive dysfunction by 1day after surgery
时间窗: from end of surgery to 1 day after surgery
The difference (OR) between the miss rate of spindle in patients with and without cognitive function change 1 day after operation.
次要结局
- correlation of delta wave miss rate and incidence of postoperative cognitive dysfunction by 3 days after surgery(from end of surgery to 3 days after surgery)
- correlation of burst suppression rate and incidence of postoperative cognitive dysfunction by 1 day after surgery(from end of surgery to 1 day after surgery)
- The difference of delta wave miss rate between patients with or without cognitive dysfunction by 3 days after surgery(from end of surgery to 3 day after surgery)
- The difference of spindle miss rate between patients with or without cognitive dysfunction by 3 days after surgery(from end of surgery to 3 days after surgery)
- correlation of spindle miss rate and incidence of death by 30 days after surgery(from end of surgery to 30 days after surgery)
- The difference of burst suppression rate between patients with or without cognitive dysfunction by 3 days after surgery(from end of surgery to 3 days after surgery)
- correlation of delta wave miss rate and incidence of postoperative cognitive dysfunction by 1 day after surgery(from end of surgery to 1 day after surgery)
- correlation of spindle miss rate and incidence of postoperative cognitive dysfunction by 1d after surgery(from end of surgery to 1d after surgery)
- correlation of spindle miss rate and incidence of postoperative cognitive dysfunction by 3 days after surgery(from end of surgery to 3 days after surgery)
- correlation of burst suppression rate and incidence of postoperative cognitive dysfunction by 3 days after surgery(from end of surgery to 3 days after surgery)
- correlation of burst suppression rate and incidence of death by 30 days after surgery(from end of surgery to 30 days after surgery)
- correlation of delta wave miss rate and incidence of death by 30 days after surgery(from end of surgery to 30 days after surgery)
研究者
Zhihong LU
professor
Air Force Military Medical University, China
研究点 (18)
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