Cognitive Dysfunction Clinical Trial
Official title:
The Effect of Hypoxic and Normoxic Cerebral Oximetry Levels and Oxidative Stress on Cognitive Functions After Carotid Endarterectomy
NCT number | NCT05652426 |
Other study ID # | ISuidiye |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2021 |
Est. completion date | January 1, 2022 |
Verified date | December 2022 |
Source | Duzce University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In this study, we investigated the effect of the capacity to cope with oxidative stress (oxidative stress response during and after clamping) in individuals with cerebral oximetry level between 40- 60 % and above 60 % and their effect on cognitive functions. Methods: In this retrospective study, patients who were scheduled for carotid endarterectomy, examined the MOCA tests before and after the operation and collected blood samples intraoperatively were included between January 2020-2021. The time periods specified below, blood samples were taken and serums were frozen at -80 celcius all this patients. Montreal cognitive function assessment test was applied before the operation, 24 hours and 7 days after the operation. Ten mililiters venous blood samples were collected to examine the status of basal neuron specific enolase, S100B, oxydative stress parameters (HAF-1 and DAF-1) at time intervals. Time intervals as follow: T1: Peripheral baseline measurements (blood will be taken from arterial blood sampling) + Cerebral Oxymeter levels + Montreal cognitive performance test + Modified Rankin Scale (mRS) T2: 1 minute before clamping (from peripheral and jugular vena blood sampling) + Cerebral Oxymeter levels T3: Before opening clamp(from peripheral and jugular vena blood sampling) + Cerebral Oxymeter levels T4: 24 hours after the procedure. (peripheral blood sampling) + Montreal cognitive performance test T5: 7 days after the operation. (peripheral blood sampling) + Montreal cognitive performance test + CO levels+ Modified Rankin Scale (mRS) Results: We found significantly positive corelation between cerebral oxymeter levels, oxydative stress parameters and cognitive performance tests in this six patient.
Status | Completed |
Enrollment | 6 |
Est. completion date | January 1, 2022 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: Patients who were scheduled for carotid endarterectomy, examined the MOCA (Montreal cognitive assesment )tests before and after the operation and collected blood samples intraoperatively were included between January 2020-2021. Exclusion Criteria: - Irregular diabetes mellitus - Pregnancy - Acute or chronic renal failure - Liver failure - History of previous carotid or brain trauma - Vasculitis - Thyroid diseases - Adrenal insufficiency - Patients who cannot perform cognitive function tests - Anemia (below 10 g/dl) - History of previous stroke in the last 6 months - Patients with plegia in the dominant upper extremity - Patients who will be shunted during the operation. - Patients with vertebrobacillary arterial system or ring of Willis anomaly - Presence of acute myocardial infarction. - Traumatic brain injuries less than 6 months before the study. |
Country | Name | City | State |
---|---|---|---|
Turkey | Ilknur Suidiye Yorulmaz | Düzce |
Lead Sponsor | Collaborator |
---|---|
Duzce University |
Turkey,
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Heyer EJ, Sharma R, Rampersad A, Winfree CJ, Mack WJ, Solomon RA, Todd GJ, McCormick PC, McMurtry JG, Quest DO, Stern Y, Lazar RM, Connolly ES. A controlled prospective study of neuropsychological dysfunction following carotid endarterectomy. Arch Neurol. 2002 Feb;59(2):217-22. doi: 10.1001/archneur.59.2.217. — View Citation
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Kuzhuget R, Starodubtsev V, Ignatenko P, Starodubtseva A, Voroshilina O, Ruzankin P, Karpenko A. The role of stump pressure and cerebral oximetry in predicting ischaemic brain damage during carotid endarterectomy. Brain Inj. 2017;31(13-14):1944-1950. doi: 10.1080/02699052.2017.1347279. Epub 2017 Sep 5. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serebral biomarkers | To investigate the correlation of brain oxygenation with cerebral biomarkers in patients with two different basal rSO2 levels (41-60% rSO2 and above 60% rSO2) in carotid endarterectomy operations. | 7 day | |
Secondary | Oxydative stress parameters | To investigate the correlation of brain oxygenation with oxydative stress biomarkers in patients with two different basal rSO2 levels (41-60% rSO2 and above 60% rSO2) in carotid endarterectomy operations. | 7 day | |
Secondary | Cognitive function | To investigate the effect of basal brain oxygenation status on postoperative cognitive function and correlation with cerebral biomarkers, oxydative stress parameters in patients with two different basal rSO2 levels (41-60% rSO2 and above 60% rSO2) in carotid endarterectomy operations. | 7 day |
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