Effects of Permissive Hypercapnia on Concentration of Postoperative Plasma Neurofilament Light in Elderly Patients Undergoing Laparoscopic Surgery:A Prospective, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Changes in plasma Neurofilament Light levels
研究概览
简要总结
The aim of this study is to conduct a prospective, single-center randomized controlled study to investigate the changes of plasma NFL concentration in patients undergoing laparoscopic surgery with mild hypercapnia, and further explore its impact on the central nervous system.
详细描述
Plasma NFL concentrations were measured preoperatively and 1 day postoperatively.
Secondary endpoints:CAM (Confusion Assessment Method) is conducted to check the subjects' baseline cognitive function preoperative day and 1 day postoperatively to assess whether delirium occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 60 years
- •duration of pneumoperitoneum greater than 60 minutes
- •American Society of Anesthesiology (ASA) status Ⅱ-Ⅲ
- •undergoing laparoscopic surgery under general anesthesia with endotracheal intubation
排除标准
- •history of mental or neurological disorders
- •preoperative use of antipsychotic drugs
- •American Society of Anesthesiology (ASA) status Ⅳ
- •severe abnormalities in heart, lung, liver, kidney, and coagulation function
- •Intracranial space-occupying lesions or major cerebrovascular diseases (such as carotid atherosclerosis and cerebral aneurysm)
- •Severe hypertension or hypotension
- •Severe metabolic acidosis or hypercapnic respiratory failure before surgery
结局指标
主要结局
Changes in plasma Neurofilament Light levels
时间窗: 1 week
Comparison of changes in plasma Neurofilament Light levels pre and postoperative in patients exposed and not exposed to hypercapnia.
次要结局
未报告次要终点
研究者
Qing-he Zhou
Principal investigator
Affiliated Hospital of Jiaxing University