the Research of the Cerebral Protection Effects of Electroencephalogram (SedLine) During Carotid Endarterectomy

NCT03622515 | Unknown

• 1 other identifier: ZYLX201818
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

Brief Summary

Fragile brain is the most common phenomenon seen in the patients undergoing CEA. The patients with fragile brain have a high incidence of postoperative brain dysfunction. This study intends to apply EEG monitoring (Sedline) to CEA to investigate whether EEG monitoring can reduce the incidence of postoperative neurological complications in CEA patients and improve their prognosis. 220 patients with CEA were randomly divided into 2 groups. Group S \[Sedline monitoring + Transcranial Doppler (TCD) + regional cerebral oxygen saturation (rS02)，n=110\] and group C \[Bispectral index (BIS)/Sedline monitoring + TCD +rSO2,n=110\], recording intraoperative and postoperative conditions, neuropsychology scale assessment, blood examination and imaging examination. The incidence of postoperative neurological complications was compared between the two groups.

Conditions

Transient Ischemic Attack; Acute Stroke; Postoperative Delirium; Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• the change from baseline of neurological complications before operation

  Transient ischemic attack, acute stroke, postoperative delirium, postoperative cognitive dysfunction, etc.

  after operation

Secondary Outcomes (1)

• the change from baseline of other complications before operation

  3 days after operation

Study Arms (2)

Group S

EXPERIMENTAL

Sedline monitoring Adjust the depth of anesthesia by adjusting the amount of anesthesia, and adjust the cerebral perfusion pressure by adjusting blood pressure

Combination Product: Anesthesia level and cerebral perfusion pressure

Group C

NO INTERVENTION

Bispectral index (BIS)/Sedline monitoring

Interventions

Anesthesia level and cerebral perfusion pressure COMBINATION_PRODUCT

Anesthetic dose and blood pressure

Group S

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective carotid endarterectomy;
• All those who agree to join the trial and sign the informed consent form;
• ASAI to III.

You may not qualify if:

• Those who refuse to sign the informed consent form;
• ASA Level IV and above;
• Unstable angina or acute myocardial infarction within 4 to 6 weeks before surgery, and heart function NYHA III to IV;
• Those with severe liver and kidney function diseases;
• Preoperative combined cognitive impairment; \[MMSE reference demarcation value: illiterate (uneducated) group ≤ 19 points, primary school (education years ≤ 6 years) group ≤ 22 points, secondary school or above (education years) 6 years) group ≤26 points; MoCA reference demarcation value: illiterate ≤13, primary school ≤19, middle school and above ≤24. \]
• Preoperative combined anxiety and depression; (SDS or SAS\>41 points)
• Patients with an endotracheal intubation returning to the ICU;
• severe allergic reactions, major bleeding, etc. during surgery, causing severe fluctuations in hemodynamics;
• The subject actively requested to withdraw from the study or to be lost to follow-up.

Sponsors & Collaborators

• Beijing Municipal Administration of Hospitals: lead

Study Sites (2)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Xuanwu hospital Captial Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (1)

• Xu N, Li LX, Wang TL, Jiao LQ, Hua Y, Yao DX, Wu J, Ma YH, Tian T, Sun XL. Processed Multiparameter Electroencephalogram-Guided General Anesthesia Management Can Reduce Postoperative Delirium Following Carotid Endarterectomy: A Randomized Clinical Trial. Front Neurol. 2021 Jul 12;12:666814. doi: 10.3389/fneur.2021.666814. eCollection 2021.

  PMID: 34322079 DERIVED

MeSH Terms

Conditions

Ischemic Attack, Transient; Stroke; Emergence Delirium; Postoperative Cognitive Complications

Interventions

Cerebrovascular Circulation

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognitive Dysfunction; Cognition Disorders

Intervention Hierarchy (Ancestors)

Blood Circulation; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2018
• First Posted: August 9, 2018
• Study Start: August 10, 2018
• Primary Completion: April 12, 2022
• Study Completion: April 12, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Locations

CN (2)