Mechanisms Mediating Postoperative Neurocognitive Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Postoperative cognitive dysfunction - delayed cognitive recovery
研究概览
简要总结
The purpose of this study is to examine the mechanisms of brain injury contributing to postoperative neurocognitive disorders (PNCD) in an at-risk population (obstructive sleep apnea (OSA)) undergoing surgery. The investigators will enroll 50 OSA patients scheduled for surgery. All patients will have a brain scan (fMRI) within five days before surgery and two days and six months after surgery. During this visit cognitive function will be assessed using the Wide Range Assessment of Memory and Learning (WRAML2) and Montreal Cognitive Assessment (MoCA) tests. Patients will also be asked to participate in a blood draw during the first 2 visits for fMRI (within five days of surgery and two days after surgery). The Confusion Assessment Method (CAM-S) test, will be used to examine postoperative delirium.
详细描述
The investigators will examine the potential mechanisms of brain injury contributing to postoperative neurocognitive disorders (PNCD) in an at-risk population (obstructive sleep apnea (OSA)). This study proposes that neuro-inflammation is associated with measurable tissue changes that can be examined with MD measures and blood biomarkers.
On the day of surgery, standard of care procedures will take place. Hemodynamic vitals will be continuously monitored. As per the latest guidelines and recommendations from the American Society of Anesthesiologists (ASA), mean arterial pressure (MAP) will be targeted to > 60 mmHg or within 20% of baseline values, and processed EEG-guided anesthesia will be monitored to maintain a patient state index between 20-50. Electronic medical records and intraoperative integrated physiologic waveform will be collected.
In summary, the investigators will examine the potential mechanisms of brain injury contributing to postoperative delirium (POD) and acute and long-lasting neurocognitive deficits in an at-risk population (OSA).
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a diagnosis of moderate-to-severe OSA (apnea hypopnea index [AHI]>15 events/hour confirmed by overnight polysomnography), scheduled for open or robotic surgery (abdominal, gynecologic, or urologic), and upper or lower extremity orthopedic procedures
排除标准
- 未提供
结局指标
主要结局
Postoperative cognitive dysfunction - delayed cognitive recovery
时间窗: Post-surgery (within two days post surgery).
Montreal Cognitive Assessment (MoCA) test
Postoperative Delirium
时间窗: A two times per day for up to three days or discharge from the hospital.
The Confusion Assessment Method (CAM-S) test
Preoperative cognitive function
时间窗: pre-surgery (within five days before)
Montreal Cognitive Assessment (MoCA) test
Postoperative cognitive dysfunction - delayed cognitive recovery II
时间窗: Post-surgery (within two days post surgery).
Wide Range Assessment of Memory and Learning (WRAML2)
Postoperative cognitive dysfunction - neurocognitive disorder II
时间窗: Post-surgery (6 months after surgery).
Wide Range Assessment of Memory and Learning (WRAML2)
Postoperative cognitive dysfunction - neurocognitive disorder
时间窗: Post-surgery (6 months after surgery).
Montreal Cognitive Assessment (MoCA) test
Preoperative cognitive function II
时间窗: pre-surgery (within five days before surgery)
Wide Range Assessment of Memory and Learning (WRAML2)
次要结局
- Blood Serum anti-inflammatory Biomarkers(pre- (within five days before surgery))
- Brain changes(pre- (within five days before) and post-surgery (within two days and 6 months).)
- Blood Serum anti-inflammatory Biomarkers II(post-surgery (within two days of surgery).)
- Brain changes II(Post-surgery (within two days post surgery).)
- Brain changes III(Post-surgery (within six months post surgery).)
研究者
Susana Vacas, MD, PhD
Physician
Massachusetts General Hospital