Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06406842

Perioperative Hemodynamic Management Based on Regional Cerebral Oxygen Saturation Monitoring in Carotid Endarterectomy

Led by Beijing Tiantan Hospital · Updated on 2025-09-08

560

Participants Needed

2

Research Sites

4 weeks

Total Duration

On this page

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for elective carotid endarterectomy
  • ASA physical status I or II
  • Aged 18 to 80 years old
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

Trial Site Locations

Total: 2 locations

1

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100053

Actively Recruiting

2

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100070

Actively Recruiting

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Research Team

Y

Yuming MD Peng, Ph.D

Y

Yuming MD Peng, Ph.D

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.

Muhan Li, Xueke Yin, Chuanyu Liang...

https://pubmed.ncbi.nlm.nih.gov/40537236