Clinical trial NCT03622515: the Research of the Cerebral Protection Effects of Electroencephalogram (SedLine) During Carotid Endarterectomy
Official title: Xuanwu Hospital Capital Medical University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transient Ischemic Attack
Acute Stroke
Postoperative Delirium
Postoperative Cognitive Dysfunction
Lead sponsor: Beijing Municipal Administration of Hospitals
Sponsor class: OTHER_GOV
First posted: 2018-08-09
Enrollment: 220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: the change from baseline of neurological complications before operation
timeFrame: after operation
Secondary outcomes:
measure: the change from baseline of other complications before operation
timeFrame: 3 days after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Xuanwu hospital Captial Medical University
state: Beijing
Study officials:
References:
citation: 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.