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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03622515
Other study ID # ZYLX201818
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 10, 2018
Est. completion date April 12, 2022

Study information

Verified date April 2022
Source Beijing Municipal Administration of Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 220
Est. completion date April 12, 2022
Est. primary completion date April 12, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Anesthesia level and cerebral perfusion pressure
Anesthetic dose and blood pressure

Locations

Country Name City State
China Xuanwu Hospital Capital Medical University Beijing Beijing
China Xuanwu hospital Captial Medical University Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Municipal Administration of Hospitals

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the change from baseline of neurological complications before operation Transient ischemic attack, acute stroke, postoperative delirium, postoperative cognitive dysfunction, etc. after operation
Secondary the change from baseline of other complications before operation acute myocardial infarction, heart failure, arrhythmia, pulmonary infection, atelectasis, acute kidney injury, etc. 3 days after operation
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