Effect of Remote Ischemic Preconditioning on Brain Injury in Carotid Endarterectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- S100-beta biomarker
研究概览
简要总结
This is a randomized controlled trial designed to test an intervention (Remote ischemic preconditioning) in patients undergoing carotid endarterectomy (CEA).Remote ischemic preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive strategy.The purpose of this study is to evaluate the effects of Remote Ischaemic Preconditioning on perioperative ischaemic injury in patients undergoing carotid endarterectomy compared to control intervention.The outcomes of interest include neurocognitive function,clinical outcomes,and biomarkers of brain injury.
详细描述
Remote ischemic preconditioning (RIPC) protocol will be induced during anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood pressure cuff inflated to a pressure 200mmHg
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)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing carotid endarterectomy
- •Patients aged 55 years to 80 years
排除标准
- •Inability to give informed consent
- •Known Deep venous thrombosis (DVT) in arm
- •Pre-existing lymphedema or axillary node dissection both arms
- •Arteriovenous fistula or graft in both arms
- •Left ventricular ejection fraction less than 50%
- •Diagnosis of dementia, intellectual disability, or mental illness including depression, anxiety, or schizophrenia
结局指标
主要结局
S100-beta biomarker
时间窗: 48 hours post surgery
tested by ELISA
次要结局
- Neuron specific enolase (NSE) biomarker(48 hours post surgery)
- Short - term cognitive function(1 day before surgery and 1 week post surgery)
- Sleep quality(1 week post surgery)