Neurocognitive Function After Carotid Thrombendarterectomy

Clinical Hospital Centre Zagreb

Status: Completed

Conditions: Neurological Impairment; Carotid Stenosis; Postoperative Cognitive Dysfunction

Treatments: Device: NIRS, EEG

Study type: Interventional

Funder types: Other

Identifiers

NCT05739357

UHCZagreb 02/21 AG

Details and patient eligibility

About

Previous studies did not reach a consensus on the influence of the type of anesthesiologic procedure and monitoring, during carotid thrombendarterectomy, on perioperative complications and cognitive outcomes. The aim of this study is the optimization of brain perfusion during the vascular carotid clamp using multimodal monitoring. We assume that standardized monitoring techniques and a better selection of cognitive tests will allow a more accurate assessment of subclinical cognitive deficits.

Full description

ABSTRACT:

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with The North American Symptomatic Carotid Endarterectomy Trial (NASCET) stenosis of more than 70%
• symptomatic stenosis
• asymptomatic stenosis
• elective surgery patients
• signed informed consent
• initial MoCa test equal and more than 22

Exclusion criteria

• who refuse to participate
• previous stroke in anamnesis
• patient without bone window for BHI measurements
• comorbidities with aphasia and plegia, and the impossibility to solve cognitive tests

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Cerebral perfusion monitoring

Active Comparator group

Description:

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.

Treatment:

Device: NIRS, EEG

Control

No Intervention group

Description:

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.