Remote Ischemic Preconditioning on Brain Injury in Carotid Endarterectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effect of Remote Ischemic Preconditioning on Brain Injury in Carotid Endarterectomy

Conditions
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Brain Injuries, Remote Ischemic Preconditioning

Intervention / Treatment
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* Procedure: Remote Ischemic Preconditioning
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing carotid endarterectomy Patients aged 55 years to 80 years Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remote Ischemic Preconditioning(RIPC)<br>RIPC 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 | Procedure: Remote Ischemic Preconditioning<br>* RIPC 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<br>* Other names: RIPC;|
| Placebo Comparator: Control<br>Control group without remote ischemic preconditioning | Procedure: Control<br>* Control group without remote ischemic preconditioning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| S100-beta biomarker | tested by ELISA | 48 hours post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short - term cognitive function | Short - term cognitive function will be tested by mini-mental state examination | 1 day before surgery and 1 week post surgery | 
| Neuron specific enolase (NSE) biomarker | tested by ELISA | 48 hours post surgery | 
| Sleep quality | Sleep quality will be test by medical outcomes study sleep scale | 1 week post surgery |