Xuanwu Hospital Capital Medical University

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

Sponsors

Lead sponsor: Beijing Municipal Administration of Hospitals

Source Beijing Municipal Administration of Hospitals
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.

Overall Status Recruiting
Start Date July 30, 2018
Completion Date July 15, 2020
Primary Completion Date July 15, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
the change from baseline of neurological complications before operation after operation
Secondary Outcome
Measure Time Frame
the change from baseline of other complications before operation 3 days after operation
Enrollment 220
Condition
Intervention

Intervention type: Combination Product

Intervention name: Anesthesia level and cerebral perfusion pressure

Description: Anesthetic dose and blood pressure

Arm group label: Group S

Eligibility

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.

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Location
facility status contact
Xuanwu Hospital Capital Medical University | Beijing, Beijing, 100053, China Recruiting Na XU 8613810001662 [email protected]
Xuanwu hospital Captial Medical University | Beijing, Beijing, 100053, China Recruiting Na XU 8613810001662 [email protected]
Location Countries

China

Verification Date

April 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Beijing Municipal Administration of Hospitals

Investigator full name: XU Na

Investigator title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Group S

Arm group type: Experimental

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

Arm group label: Group C

Arm group type: No Intervention

Description: Bispectral index (BIS)/Sedline monitoring

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Outcomes Assessor)

Source: ClinicalTrials.gov