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NCT Number: NCT05739357

Neurocognitive Function After Carotid Thrombendarterectomy

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.

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Key information

Conditions

Carotid Stenosis Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Neurological Impairment Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Cognitive Dysfunction Postoperative Complications Signs and Symptoms Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UHCZagreb

Zagreb, 10000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIRS, EEG

Device

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 names: cerebral oximetry

Primary outcomes

  1. Montreal Cognitive Assessment (MoCA)

    Time frame: 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

    A widely used screening assessment for detecting cognitive impairment. It was validated in the setting of mild cognitive impairment, and has subsequently been adopted in numerous other settings clinically. This test consists of 30 points and takes part in 10 minutes from the individual. The Montreal test is performed in seven steps. The basics of this test include short-term memory, executable performance, attention, focus and more.

  2. Trail making test (TMT) 1

    Time frame: 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

    Neuropsychological test that involves visual scanning and working memory. In the TMT-1 (rote memory) the subject is instructed to connect a set of 25 dots as quickly as possible (time is measured in seconds).

  3. Trail making test (TMT) 2

    Time frame: Changes in measurements done at four time points (before surgery, day after the surgery, on 7th day and after 8 weeks

    TMT-2 (executive functioning) is a neuropsychological test that involves visual scanning and working memory. In this test the dots go from 1 to 13 and include letters from A to L.

  4. Month backwards test (MBT)

    Time frame: changes in measurements done at four time points (before surgery, day after the surgery, on 7th day and after 8 weeks

    It is a rapid (< 2 min) and simple to administer test of cognitive function that is widely used at the bedside. The test requests the subject to recite the months of the year in reverse order starting with December, until the subject reaches January.

Secondary outcomes

  1. Difference in brain reactivity measured by Breath holding index

    Time frame: 8 weeks

    Difference in breath holding index before surgery , after the surgery and after eight weeks as a surrogate of brain perfusion in both groups of patients

Sponsors and collaborators

Lead sponsor

Clinical Hospital Centre Zagreb

Other

Registry information

Official study title

Perioperative Complications and Cognitive Outcome in Carotid Thrombendarterectomy With Multimodal Monitoring Cerebral Perfusion Optimisation

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 22, 2023
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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