NCT03622515|Unknown
the Research of the Cerebral Protection Effects of Electroencephalogram (SedLine) During Carotid Endarterectomy
Xuanwu Hospital Capital Medical University
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Xuanwu Hospital Capital Medical University
Sponsor study identifier
interventional
220
1 country
2
Study Start
August 10, 2018
Actual (reported)Primary Completion
April 12, 2022
Actual (reported)Study Completion
April 12, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 12, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 29, 2018
Actual (reported)August 9, 2018
Actual (reported)August 10, 2018
Actual (reported)April 12, 2022
Actual (reported)April 12, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
the change from baseline of neurological complications before operation
Transient ischemic attack, acute stroke, postoperative delirium, postoperative cognitive dysfunction, etc.
after operation
the change from baseline of other complications before operation
3 days after operation
Sedline monitoring Adjust the depth of anesthesia by adjusting the amount of anesthesia, and adjust the cerebral perfusion pressure by adjusting blood pressure
Bispectral index (BIS)/Sedline monitoring
Anesthetic dose and blood pressure
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Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053, China
Xuanwu hospital Captial Medical University
Beijing, Beijing Municipality, 100053, China
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.
First Submitted
July 29, 2018
First Posted
August 9, 2018
Study Start
August 10, 2018
Actual (reported)Primary Completion
April 12, 2022
Actual (reported)Contact the study team to confirm eligibility.
Study Completion
April 12, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 13, 2022
Record last verified: 2022-04
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