Remote Ischemic Preconditioning on Brain Injury in Carotid Endarterectomy

Not Applicable

• Conditions: Brain Injuries; Remote Ischemic Preconditioning
• Interventions: Procedure: Remote Ischemic Preconditioning; Procedure: Control

• Registration Number: NCT03027011
• Lead Sponsor: The Affiliated Hospital of Xuzhou Medical University

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-18
• Study First Posted: 2017-01-20
• Status Verified: 2017-03
• Study Start: 2017-03-01
• Last Update Submitted: 2017-03-09
• Last Update Posted: 2017-03-10
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote Ischemic Preconditioning(RIPC)	Remote Ischemic Preconditioning	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
Control	Control	Control group without remote ischemic preconditioning

Primary Outcome Measures

Name	Time	Method
S100-beta biomarker	48 hours post surgery	tested by ELISA

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China