Neurocognitive Function After Carotid Thrombendarterectomy

NCT05739357 | Completed

• 1 other identifier: UHCZagreb 02/21 AG
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Stenosis; Postoperative Cognitive Dysfunction; Neurological Impairment

Keywords

CEA ACI; cognitive tests; BHI; NIRS; TCD; EEG

Outcome Measures

Primary Outcomes (4)

• Montreal Cognitive Assessment (MoCA)

  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.

  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

• Trail making test (TMT) 1

  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).

  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

• Trail making test (TMT) 2

  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.

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

• Month backwards test (MBT)

  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.

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

Secondary Outcomes (1)

• Difference in brain reactivity measured by Breath holding index

  8 weeks

Study Arms (2)

Cerebral perfusion monitoring

ACTIVE COMPARATOR

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.

Device: NIRS, EEG

Control

NO INTERVENTION

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.

Interventions

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.

Also known as: cerebral oximetry

Cerebral perfusion monitoring

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Hospital Centre Zagreb: lead

Study Sites (1)

UHCZagreb

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Carotid Stenosis; Postoperative Cognitive Complications; Neurologic Manifestations

Interventions

Spectroscopy, Near-Infrared; Electroencephalography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Diagnostic Techniques, Neurological; Electrodiagnosis

Study Officials

• Tina Tomic Mahecic

  UHC Zagreb

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant anesthesiologist

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: February 22, 2023
• Study Start: August 1, 2019
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)