Neurocognitive Function After Carotid Thrombendarterectomy
NCT ID: NCT05739357
Last Updated: 2023-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2019-08-01
2023-10-01
Brief Summary
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Detailed Description
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AIM OF THE STUDY: Effect of perioperative multimodal monitoring with transcranial doppler (TCD), near-infrared spectroscopy (NIRS), and Electroencephalography (EEG) in patients for carotid thrombendarterectomy (CEA) on perioperative complications and cognitive functions.
PATIENTS AND METHODS: The prospective study will analyze 80 consecutive patients with an asymptomatic and symptomatic (transitory ischemic attack, TIA, in anamnesis) stenosis of the internal carotid artery in which CEA is indicated in general anesthesia. Cognitive tests will be analyzed for all patients preoperatively, first and eighth day postoperatively, and after 8 weeks. Breath-holding index (BHI) will be measured preoperatively and postoperatively. The first group of patients (n = 40) will have expanded intraoperative monitoring involving TCD, NIRS, and EEG, and the control group (n = 40) will have only standard anesthetic monitoring.
EXPECTED CONTRIBUTION OF THE STUDY: Previous studies did not agree on the influence of the type of anesthesiologic procedure and monitoring of perioperative complications and cognitive outcomes. We assume that standardized monitoring techniques and a better selection of cognitive tests will allow a more accurate assessment of the effect.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Cerebral perfusion monitoring
Multimodal monitoring includes cerebral oxygenation (with NIRS) and EEG (with SEDLINE). During the carotic clamp, if cerebral oxygenation decreased for more than 12 % on the operating side from the baseline value, simple interventions as, increasing arterial blood pressure, increasing arterial carbon dioxide tension or increasing oxygen inspiration concentration will be performed.
NIRS, EEG
During the carotic clamp, if cerebral oxygenation decreased for more than 12 % on the operating side from the baseline value, simple interventions as, increasing arterial blood pressure, increasing arterial carbon dioxide tension or increasing oxygen inspiration concentration will be performed.
Control
The control arm does not have any monitor of cerebral perfusion and oxygenation, during the carotic clamp only intervention is regulating arterial blood pressure values.
No interventions assigned to this group
Interventions
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NIRS, EEG
During the carotic clamp, if cerebral oxygenation decreased for more than 12 % on the operating side from the baseline value, simple interventions as, increasing arterial blood pressure, increasing arterial carbon dioxide tension or increasing oxygen inspiration concentration will be performed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* symptomatic stenosis
* asymptomatic stenosis
* elective surgery patients
* signed informed consent
* initial MoCa test equal and more than 22
Exclusion Criteria
* previous stroke in anamnesis
* patient without bone window for BHI measurements
* comorbidities with aphasia and plegia, and the impossibility to solve cognitive tests
18 Years
90 Years
ALL
No
Sponsors
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Clinical Hospital Centre Zagreb
OTHER
Responsible Party
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Tina Tomic Mahecic
Consultant anesthesiologist
Principal Investigators
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Tina Tomic Mahecic
Role: PRINCIPAL_INVESTIGATOR
UHC Zagreb
Locations
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UHCZagreb
Zagreb, , Croatia
Countries
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Other Identifiers
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UHCZagreb 02/21 AG
Identifier Type: -
Identifier Source: org_study_id