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

Carotid Endarterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06406842
• Other study ID #: 202422047
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Beijing Tiantan Hospital
• Contact: Yuming MD Peng, Ph.D
• Phone: 8610-59976658
• Email: florapym766[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 560
• Est. completion date: December 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 1. Patients scheduled for carotid endarterectomy, 2.aged 18-80 years old, 3. patients or their legally authorized representatives consented to participate in this trial and signed the informed consent form.

Exclusion Criteria:

• 1. Patients with severe cognitive impairment who are unable to undergo follow-up assessments , 2.history of psychiatric medication use, 3.history of intracranial surgery; impaired hearing or vision, and language disorders.

Related Conditions & MeSH terms

• Carotid Endarterectomy
• Cerebral Autoregulation

Intervention

Other:
• Cerebral Oxygenation index guided hemodynamics management
The anesthesiologist monitors the patient's cerebral oxygen index to ensure it stays below the established threshold.
• routine hemodynamics management
The anesthesiologist's clinical task was to maintain the patient's MAP within ± 20% of the baseline MAP.

Locations

Country	Name	City	State
China	Beijing Tian Tan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of postoperative cerebral ischemic events	Diffusion-weighted imaging (DWI) on MRI reveals high signal lesions indicative of new infarcts, either accompanied by overt neurological symptoms (overt stroke) or without accompanying symptoms (covert stroke).	postoperative 3 day