Perioperative Application of Hemodynamic Management Based on Regional Cerebral Oxygen Saturation Monitoring of Cerebral Autoregulation in Carotid Endarterectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 560
- 试验地点
- 3
- 主要终点
- The incidence of postoperative cerebral ischemic events
研究概览
简要总结
Carotid endarterectomy (CEA) is used to treat symptomatic extracranial internal carotid artery stenosis. The occult stroke of CEA patients evaluated by magnetic resonance imaging 3 days after operation was as high as 17%. Cerebral blood flow autoregulation (CA) is the ability of the brain to maintain the relative stability of cerebral blood flow, and cerebral oxygen index (COx) can be used to reflect CA. A negative value of cerebral oxygen index or a value near zero indicates that CA is complete, and cerebral oxygen index close to 1 indicates that CA has lost its ability. In theory, real-time monitoring of CA function by cerebral oxygen index and individualized management strategy with this goal can potentially reduce perioperative ischemic brain injury. The purpose of this study is to explore the influence of the management strategy of monitoring CA function based on regional cerebral oxygen saturation on the postoperative neurological complications of CEA patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The investigator of control group
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective carotid endarterectomy
- •ASA Ⅱ or Ⅲ
- •aged 18-80 years old
排除标准
- •preoperative moderate and severe cognitive impairment
- •preoperative psychotropic medication history within one year
- •history of neurosurgery
- •have speech or language impairments
结局指标
主要结局
The incidence of postoperative cerebral ischemic events
时间窗: postoperative 3 day
Our primary outcome will be the incidence of new ischemic brain injury within 3 days after surgery, defined as new infarct focus detected by magnetic resonance imaging diffusion-weighted imaging or computed tomography, with or without new-onset limb weakness, paresthesia, or language abnormalities. Diffusion-weighted imaging sequences will be used at each scan to detect acute ischemic brain lesions.
次要结局
- The incidence of postoperative delirium(The first 3 days after surgery)
- Advanced Cognitive Assessment(The day before surgery and postoperative day 4 or 5)
- Pain assessment(At 24, 48, and 72 hours post-surgery)
- Basic Cognition Assessment(The day before surgery and postoperative day 4 or 5)
研究者
Yuming Peng
Deputy chief of Department of Anesthesiology
Beijing Tiantan Hospital