Clinical trial NCT05739357: Neurocognitive Function After Carotid Thrombendarterectomy
Official title: Perioperative Complications and Cognitive Outcome in Carotid Thrombendarterectomy With Multimodal Monitoring Cerebral Perfusion Optimisation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Stenosis
Postoperative Cognitive Dysfunction
Neurological Impairment
Keywords: CEA ACI
cognitive tests
BHI
NIRS
TCD
EEG
Lead sponsor: Clinical Hospital Centre Zagreb
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Change in measurements (result is in numbers) done at four time points (before surgery, day after the surgery, on 7th day and after 8 weeks
measure: Trail making test (TMT) 1
timeFrame: Changes in measurements (results are in seconds) done at four time points (before surgery, day after the surgery, on 7th day and after 8 weeks
measure: Trail making test (TMT) 2
timeFrame: Changes in measurements done at four time points (before surgery, day after the surgery, on 7th day and after 8 weeks
measure: Month backwards test (MBT)
timeFrame: changes in measurements done at four time points (before surgery, day after the surgery, on 7th day and after 8 weeks
Secondary outcomes:
measure: Difference in brain reactivity measured by Breath holding index
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: UHCZagreb
Study officials:
affiliation: UHC Zagreb
name: Tina Tomic Mahecic
role: PRINCIPAL_INVESTIGATOR
References: