Brain Injuries, Remote Ischemic Preconditioning
Conditions
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
Interventions
PROCEDURERemote 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
PROCEDUREControl
Control group without remote ischemic preconditioning
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| S100-beta biomarker | 48 hours post surgery | tested by ELISA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Neuron specific enolase (NSE) biomarker | 48 hours post surgery | tested by ELISA |
| Sleep quality | 1 week post surgery | Sleep quality will be test by medical outcomes study sleep scale |
Countries
China
Contacts
Primary ContactChen Xiuxia, MD
Outcome results
None listed