Postoperative Cognitive Dysfunction Clinical Trial
Official title:
Perioperative Complications and Cognitive Outcome in Carotid Thrombendarterectomy With Multimodal Monitoring Cerebral Perfusion Optimisation
Verified date | November 2023 |
Source | Clinical Hospital Centre Zagreb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | October 1, 2023 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Croatia | UHCZagreb | Zagreb |
Lead Sponsor | Collaborator |
---|---|
Clinical Hospital Centre Zagreb |
Croatia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Difference in brain reactivity measured by Breath holding index | 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 | 8 weeks |
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