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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03622515
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : March 8, 2022
Sponsor:
Information provided by (Responsible Party):
XU Na, Beijing Municipal Administration of Hospitals

Study Description
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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.


Condition or disease Intervention/treatment Phase
Transient Ischemic Attack Acute Stroke Postoperative Delirium Postoperative Cognitive Dysfunction Combination Product: Anesthesia level and cerebral perfusion pressure Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Xuanwu Hospital Capital Medical University
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : March 30, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Group S
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
Anesthetic dose and blood pressure
No Intervention: Group C
Bispectral index (BIS)/Sedline monitoring


Outcome Measures
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Primary Outcome Measures :
  1. the change from baseline of neurological complications before operation [ Time Frame: after operation ]
    Transient ischemic attack, acute stroke, postoperative delirium, postoperative cognitive dysfunction, etc.


Secondary Outcome Measures :
  1. the change from baseline of other complications before operation [ Time Frame: 3 days after operation ]
    acute myocardial infarction, heart failure, arrhythmia, pulmonary infection, atelectasis, acute kidney injury, etc.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Those who refuse to sign the informed consent form;
  2. ASA Level IV and above;
  3. Unstable angina or acute myocardial infarction within 4 to 6 weeks before surgery, and heart function NYHA III to IV;
  4. Those with severe liver and kidney function diseases;
  5. 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. ]
  6. Preoperative combined anxiety and depression; (SDS or SAS>41 points)
  7. Patients with an endotracheal intubation returning to the ICU;
  8. severe allergic reactions, major bleeding, etc. during surgery, causing severe fluctuations in hemodynamics;
  9. The subject actively requested to withdraw from the study or to be lost to follow-up.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622515


Locations
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China, Beijing
Xuanwu Hospital Capital Medical University Recruiting
Beijing, Beijing, China, 100053
Contact: Na XU    8613810001662    xinan_xu@126.com   
Xuanwu hospital Captial Medical University Recruiting
Beijing, Beijing, China, 100053
Contact: Na XU    8613810001662    xinan_xu@126.com   
Sponsors and Collaborators
Beijing Municipal Administration of Hospitals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: XU Na, Principal Investigator, Beijing Municipal Administration of Hospitals
ClinicalTrials.gov Identifier: NCT03622515    
Other Study ID Numbers: ZYLX201818
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: March 8, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Stroke
Ischemic Attack, Transient
Postoperative Cognitive Complications
Cognitive Dysfunction
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia
Postoperative Complications
Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs