Perioperative Complications and Cognitive Outcome in Carotid Thrombendarterectomy With Multimodal Monitoring Cerebral Perfusion Optimisation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Carotid Stenosis
- Sponsor
- Clinical Hospital Centre Zagreb
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Montreal Cognitive Assessment (MoCA)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Tina Tomic Mahecic
Consultant anesthesiologist
Clinical Hospital Centre Zagreb
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
Outcomes
Primary Outcomes
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.
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).
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.
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
- Difference in brain reactivity measured by Breath holding index(8 weeks)