Association Between Cerebral Oxygen Consumption Responsiveness to Increased Oxygen Supply and Postoperative Delirium: A Prospective Observational Study Using Functional Near-Infrared Spectroscopy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Delirium
研究概览
简要总结
The goal of this observational study is to learn whether the brain's ability to use oxygen during surgery is associated with postoperative delirium in adults aged 65 years and older undergoing general anesthesia.
The main question it aims to answer is:
- Does reduced cerebral oxygen consumption responsiveness during surgery increase the risk of postoperative delirium in older patients?
Participants who are undergoing elective laparoscopic surgery under general anesthesia as part of their routine medical care will have brain oxygen levels measured during surgery using a non-invasive forehead sensor, and will be assessed for delirium for up to three 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
- 否
入选标准
- •Patients undergoing elective laparoscopic surgery under general anesthesia
- •Age 65 years or older
排除标准
- •Diagnosis of dementia or presence of delirium before surgery
- •Loss of capacity to provide informed consent
- •Moderate or severe cerebrovascular stenosis diagnosed before surgery
- •Moderate or severe obstructive or restrictive pulmonary dysfunction identified on preoperative pulmonary function testing
- •Requirement for supplemental oxygen therapy before surgery
- •History of neurological disorders (e.g., Parkinson's disease, stroke) or prior brain surgery
- •Severe hepatic dysfunction (AST or ALT > 120 IU/L)
- •Severe renal dysfunction (estimated GFR < 15 mL/min/1.73 m²)
- •Persistent severe hemodynamic instability (mean arterial pressure < 60 mmHg)
- •Skin conditions preventing placement of the forehead fNIRS sensor
- •Combined surgical procedures performed concurrently
- •Planned postoperative admission to the intensive care unit
研究组 & 干预措施
Older patients undergoing elective laparoscopic surgery
Adults aged 65 years and older undergoing elective laparoscopic surgery under general anesthesia will be prospectively observed. During surgery, cerebral oxygen levels will be measured using a non-invasive forehead sensor to assess the brain's oxygen utilization response within the range of routine anesthesia care. Participants will be followed for up to three days after surgery to evaluate the occurrence of postoperative delirium.
干预措施: Intraoperative Cerebral Oxygen Utilization Assessment (Other)
结局指标
主要结局
Incidence of Postoperative Delirium
时间窗: Up to 3 days after surgery
Postoperative delirium diagnosed using 3D-CAM conducted in the post-anesthesia care unit and hospital ward. Delirium will be defined as at least one positive assessment during the first three postoperative days.
次要结局
- Intraoperative Cerebral Oxygen Utilization Response (ΔHbO-HbR)(During surgery)