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Recruiting Observational

Association Between Local Cerebral Oxygenation Monitoring and Postoperative Delirium in Carotid Endarterectomy

NCT05198635 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2022-02-14
Last updated
2025-02-13

Condition(s) studied

Cerebral Oxygen SaturationPostoperative DeliriumCarotid Endarterectomy

Investigational drug(s) / intervention(s)

local cerebral oxygen saturation

local cerebral oxygen saturation: minimum SctO2, SctO2 drop/rise defined by different thresholds, and area under/above the threshold

Study summary

Postoperative delirium (POD) is a common perioperative complication, which can lead to adverse outcomes. Patients undergoing carotid endarterectomy (CEA) were elderly, complicated with vascular risk factors, cognitive dysfunction, some also had a history of stroke, and the circulation fluctuated greatly during the operation, often resulting in hypoperfusion of cerebral tissue and hypoxia. Therefore, they're the high-risk group of POD. Near-infrared Spectroscopy (NIRS) can continuously and noninvasively monitor local cerebral oxygen saturation (SctO2) to identify the mismatch of oxygen supply and demand in brain tissue. However, for CEA patients, the association between intraoperative SctO2 changes and POD remains unclear. This study intends to explore the association between them and determine the SctO2 threshold for predicting POD. We will monitor SctO2 intraoperatively, follow up and collect data postoperatively.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: Scheduled carotid endarterectomy; Signed informed consent. Exclusion Criteria: Severe cognitive impairment(Mini-Mental State Examination, MMSE\<18); History of psychotropic drugs; Previous intracranial surgery history; Poor hearing or vision; Language barriers

Primary outcome measure(s)

  • Postoperative delirium — With postoperative 5 day
    Postoperative delirium is assessed by the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) when the patient is in intensive care unit or general ward, respectively.

Trial sites (1)

FacilityCityRegionStatus
Beijing Tian Tan Hospital, Capital Medical University Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05198635 on ClinicalTrials.gov ↗ ← All trials in China