Hemodynamic Management Using Regional Cerebral Oxygen Monitoring to Reduce Stroke Risk After Carotid Endarterectomy
Led by Beijing Tiantan Hospital · Updated on 2025-09-08
560
Participants Needed
2
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the impact of monitoring cerebral autoregulation function using regional cerebral oxygen saturation on postoperative neurological complications in patients undergoing carotid endarterectomy CEA. This surgery treats symptomatic narrowing of the extracranial internal carotid artery but carries a risk of silent strokes detected by MRI shortly after the operation. The study aims to see if real-time monitoring of cerebral oxygen index, which reflects autoregulation, can reduce ischemic brain injury around the time of surgery.
Participants are randomly assigned to one of two groups. In the autoregulation group, anesthesiologists maintain the cerebral oxygen index below 0.3 by adjusting blood pressure with norepinephrine or phenylephrine infusions or by modifying oxygen and carbon dioxide levels to improve brain oxygen saturation. In the routine care group, anesthesiologists do not see the cerebral oxygen index and manage blood pressure within 20% of baseline using similar vasoactive drugs, while keeping carbon dioxide and oxygen levels within standard ranges.
During the study, participants are evaluated for cerebral ischemic events within 3 days after surgery, with additional assessments including delirium during the first 3 days, cognitive tests before surgery and about 4 to 5 days after surgery, and pain levels at 24, 48, and 72 hours post-surgery. The study enrolls adults aged 18 to 80 scheduled for elective CEA and monitors them closely with brain oxygenation and clinical assessments to understand how cerebral autoregulation management affects recovery and complications.
CONDITIONS
Brief Title
Association Between Local Cerebral Oxygenation Monitoring and Postoperative Stroke in Carotid Endarterectomy
Research Team
Y
Yuming MD Peng, Ph.D
Y
Yuming MD Peng, Ph.D
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Patients scheduled for elective carotid endarterectomy
ASA physical status I or II
Aged 18 to 80 years old
You will not qualify if you...
Moderate or severe cognitive impairment before surgery
History of psychotropic medication use within one year
Prior brain surgery
Speech or language impairments
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Day of surgery
Participants undergo carotid endarterectomy with hemodynamic management guided by cerebral oxygenation monitoring or routine management according to their assigned group.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - 3 to 5 days post-surgery
Participants are monitored for cerebral ischemic events, delirium, cognition, and pain during the first few days after surgery.
Daily visits for up to 5 days post-surgery
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Effect of perioperative haemodynamic management based on cerebral autoregulation monitored by Cerebral Oximetry Index during carotid endarterectomy: protocol of a randomised trial.