Remote Ischemic Preconditioning on Brain Injury in Carotid Endarterectomy

Xuzhou Medical University

Status: Unknown

Conditions: Brain Injuries; Remote Ischemic Preconditioning

Treatments: Procedure: Remote Ischemic Preconditioning; Procedure: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03027011

XYFY-2017-005

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Remote Ischemic Preconditioning(RIPC)

Active Comparator group

Description:

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

Treatment:

Procedure: Remote Ischemic Preconditioning

Control

Placebo Comparator group

Description:

Control group without remote ischemic preconditioning

Treatment:

Procedure: Control