NCT03622515

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

Xuanwu Hospital Capital Medical University

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Beijing Municipal Administration of Hospitals · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Anesthesia level and cerebral perfusion pressure	Anesthetic dose and blood pressure

Timeline

• Start date: 2018-08-10
• Primary completion: 2022-04-12
• Completion: 2022-04-12
• First posted: 2018-08-09
• Last updated: 2022-04-13

Locations

2 sites across 1 country: China