Neurocognitive Function After Carotid Thrombendarterectomy

Sponsor

Clinical Hospital Centre Zagreb (Other)

Overall Status

Recruiting

CT.gov ID

NCT05739357

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Stenosis Postoperative Cognitive Dysfunction Neurological Impairment	Device: NIRS, EEG	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Device: 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 Names: cerebral oximetry
No Intervention: 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.

Arm

Intervention/Treatment

Active Comparator: 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.

Device: 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 Names:

cerebral oximetry

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

Montreal Cognitive Assessment (MoCA) [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.
Trail making test (TMT) 1 [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).
Trail making test (TMT) 2 [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.
Month backwards test (MBT) [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 Outcome Measures

Difference in brain reactivity measured by Breath holding index [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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