Association Between Local Cerebral Oxygenation Monitoring and Postoperative Stroke in Carotid Endarterectomy

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

Carotid endarterectomy (CEA) is used to treat symptomatic extracranial internal carotid artery stenosis. The occult stroke of CEA patients evaluated by magnetic resonance imaging 3 days after operation was as high as 17%. Cerebral blood flow autoregulation (CA) is the ability of the brain to maintain the relative stability of cerebral blood flow, and cerebral oxygen index (COx) can be used to reflect CA. A negative value of cerebral oxygen index or a value near zero indicates that CA is complete, and cerebral oxygen index close to 1 indicates that CA has lost its ability. In theory, real-time monitoring of CA function by cerebral oxygen index and individualized management strategy with this goal can potentially reduce perioperative ischemic brain injury. The purpose of this study is to explore the influence of the management strategy of monitoring CA function based on regional cerebral oxygen saturation on the postoperative neurological complications of CEA patients.

Study Overview

• Status: Recruiting
• Conditions: Carotid Endarterectomy; Cerebral Autoregulation
• Intervention / Treatment: Other: Cerebral oxygenation index guided hemodynamics management

• Study Type: Interventional
• Enrollment (Estimated): 560
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuming MD Peng, Ph.D; Phone Number: 8610-59976658; Email: florapym766@163.com
• Study Contact Backup: Name: Yuming MD Peng, Ph.D; Phone Number: 861059976658; Email: florapym766@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100053
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Lei Zhao; Phone Number: 13811035886; Email: zhaoalei@sina.com
    • Beijing, Beijing Municipality, China, 100070
      • Recruiting
      • Beijing Tian Tan Hospital, Capital Medical University
      • Contact: Yuming Peng; Phone Number: 8610-59976658; Email: florapym766@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients scheduled for elective carotid endarterectomy
• ASA Ⅱ or Ⅲ
• aged 18-80 years old

Exclusion Criteria:

• preoperative moderate and severe cognitive impairment
• preoperative psychotropic medication history within one year
• history of neurosurgery
• have speech or language impairments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The autoregulation group; In the autoregulation group, anesthesiologist will maintain that the cerebral oxygen index value below 0.3. If cerebral oxygen index exceeds the threshold, Norepinephrine or Phenylephrine will be infused continuously, or arterial partial pressure of oxygen or arterial partial pressure of carbon dioxide will be adjusted to increase regional cerebral oxygen saturation.	Other: Cerebral oxygenation index guided hemodynamics management; In the autoregulation group, anesthesiologist will maintain that the cerebral oxygen index value below 0.3. If cerebral oxygen index exceeds the threshold, norepinephrine or phenylephrine will be infused continuously, or arterial partial pressure of oxygen or arterial partial pressure of carbon dioxide will be adjusted to increase regional cerebral oxygen saturation.
No Intervention: The routine group; In the routine group, the screen of the collection monitor will be covered by a black cloth . Anesthesiologist will not have access to the patient's cerebral oxygen index value. Anesthesiologist will strive to maintain mean arterial pressure within a ± 20% range of their baseline mean arterial pressure. Outside of this range, the same vasoactive drugs will be employed for modulation. Additionally, anaesthesiologists will maintain PaCO₂ within the range of 35-45 mmHg and set the fraction of inspired oxygen at 50%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of postoperative cerebral ischemic events	Our primary outcome will be the incidence of new ischemic brain injury within 3 days after surgery, defined as new infarct focus detected by magnetic resonance imaging diffusion-weighted imaging or computed tomography, with or without new-onset limb weakness, paresthesia, or language abnormalities. Diffusion-weighted imaging sequences will be used at each scan to detect acute ischemic brain lesions.	postoperative 3 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of postoperative delirium	The incidence and severity of postoperative delirium will be assessed during the first 3 days after surgery. Delirium will be assessed twice daily between 8:00-10:00 and 18:00-20:00 in ward patients with the Richmond Agitation Sedation Scale (RASS) and the 3 min diagnostic interview for CAM (3D-CAM). ICU patients will be similarly assessed with RASS and the confusion assessment method for ICU (CAM-ICU). Any positive 3D-CAM or CAM-ICU assessment will be considered evidence of delirium.	The first 3 days after surgery
Basic Cognition Assessment	Postoperative basic cognitive function will be assessed by Mini-mental State Examination. This will be rated on a scale from 0 to 30, higher cores corresponded to higher levels of cognitive function.	The day before surgery and postoperative day 4 or 5
Advanced Cognitive Assessment	Postoperative basic cognitive function will be assessed by Montreal Cognitive Assessment-Basic Examination. This will be rated on a scale from 0 to 30, higher cores corresponded to higher levels of cognitive function.	The day before surgery and postoperative day 4 or 5
Pain assessment	Pain scores will be recorded at rest and during movement . The pain was rated on a scale from 0 to 10, where 0 indicated no pain and 10 indicated the worst possible pain. Higher scores corresponded to higher levels of pain.	At 24, 48, and 72 hours post-surgery

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Yuming MD Peng, Ph.D, Beijing Tian tan Hospital

Publications and helpful links

General Publications

• Li M, Yin X, Liang C, Tao C, Yan Q, Zeng M, Li S, Sessler DI, Wang R, Zhao L, Peng Y. Effect of perioperative haemodynamic management based on cerebral autoregulation monitored by Cerebral Oximetry Index during carotid endarterectomy: protocol of a randomised trial. BMJ Open. 2025 Jun 19;15(6):e094156. doi: 10.1136/bmjopen-2024-094156.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 202422047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No