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

NCT06406842 | Recruiting

• 1 other identifier: 202422047
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Carotid Endarterectomy; Cerebral Autoregulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The incidence of postoperative delirium

  The first 3 days after surgery

• Basic Cognition Assessment

  The day before surgery and postoperative day 4 or 5

• Advanced Cognitive Assessment

  The day before surgery and postoperative day 4 or 5

• Pain assessment

  At 24, 48, and 72 hours post-surgery

Study Arms (2)

The autoregulation group

EXPERIMENTAL

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

The routine group

NO INTERVENTION

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%.

Interventions

Cerebral oxygenation index guided hemodynamics management OTHER

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.

The autoregulation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (2)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40537236 DERIVED

Study Officials

• Yuming MD Peng, Ph.D

  Beijing Tian Tan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuming MD Peng, Ph.D

CONTACT

8610-59976658; florapym766@163.com

Yuming MD Peng, Ph.D

CONTACT

861059976658; florapym766@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The investigator of control group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief of Department of Anesthesiology

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: July 8, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)