Ignite Creation Date:
2024-05-06 @ 6:25 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05652426
Status:
COMPLETED
Last Update Posted:
2022-12-15
First Post:
2022-12-07
Brief Title:
The Effect of Hypoxic and Normoxic Cerebral Oximetry Levels on Cognitive Functions After Carotid Endarterectomy
Sponsor:
Duzce University
Organization:
Duzce University
Study Overview
Official Title:
The Effect of Hypoxic and Normoxic Cerebral Oximetry Levels and Oxidative Stress on Cognitive Functions After Carotid Endarterectomy
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 clampfrom 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
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 clampfrom 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
Detailed Description:
In this retrospective study 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 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 MoCA Modified Rankin Scale mRS T2 1 minute before clamping from peripheral and jugular vena blood sampling Cerebral Oxymeter levels T3 Before opening clampfrom peripheral and jugular vena blood sampling Cerebral Oxymeter levels T4 24 hours after the procedure peripheral blood sampling MoCA test T5 7 days after the operation peripheral blood sampling MoCA CO levels Modified Rankin Scale The degree of stenosis was determined according to the North American Symptomatic Carotid Endarterectomy Trial NASCET criteria Written informed consent form was obtained from the patients 1 day before the operation Basal invasive arterial blood pressure pulse oximetry heart rate cerebral perfusion pressure cerebral oximetry levels records of all patients were taken as baseline values before the operation During the operation serum samples were taken and 5 ml blood samples were taken from the artery peripheral and 5 ml from the vena jugularis interna during the operation Blood samples were immediately centrifuged at 15000 rpm for 15 minutes and the supernatant was collected The supernatant was immediately stored at -80 C for further analysis of oxidative stress and other parameters The parameters studied are Human NSENeuron Specific Enolase ELISA Kit Neuron Specific Enolase ELISA Kit Human S100B S100 Calcium Binding Protein B ELISA Kit HIF-1α Hypoxia Inducible Factor 1 Alpha ELISA Kit Human DAFDecay Accelerating Factor ELISA Kit
A General anesthesia procedure Anesthesia induction was performed with 1-2 mgkg propofol 1 mcgkg fentanyl 05 mgkg rocuronium Anesthesia was maintained with remifentanil infusion 005-01 mcgkgmin 1-2 sevoflurane 1 MAC and rocuronium Mechanical ventilation parameters were adjusted to be within the limits of end-tidal carbon dioxide normocarby 35-45mm Hg mean 40 mmHg To prevent the development of bradycardia 1 lidocaine was applied to the internal external and common carotid arteries by the surgical team Following systemic intravenous 5000 IU heparin administration carotid arterial cross-clamp was placed with appropriate active clotting time 200 B Superficial and deep cervical blockade It was done with 05 isobaric bupivacaine 15 ml 2 prilocaine 5 ml
ΔrSO2 100 x rSO2preclamping - rSO2baseline rSO2baseline Baseline rSO2 value rSO2 measurement for each specific time point and rSO2 change between them were continuously monitored by oximetry Invos System 4100 Somonetics Corporation Troy MI USA The entire CEA surgical procedure was performed with the standardized technique in these 6 patients
In the analysis phase the patients were evaluated in 2 groups Group 1 Basal cerebral oximetry levels between 41-60 Group 2 Basal cerebral oximetry levels 61
T1 Peripheral baseline measurements blood will be taken from arterial blood sampling Cerebral Oxymeter levels MoCA Modified Rankin Scale mRS T2 1 minute before clamping from peripheral and jugular vena blood sampling Cerebral Oxymeter levels T3 Before opening clampfrom peripheral and jugular vena blood sampling Cerebral Oxymeter levels T4 24 hours after the procedure peripheral blood sampling MoCA test T5 7 days after the operation peripheral blood sampling MoCA CO levels Modified Rankin Scale The degree of stenosis was determined according to the North American Symptomatic Carotid Endarterectomy Trial NASCET criteria Written informed consent form was obtained from the patients 1 day before the operation Basal invasive arterial blood pressure pulse oximetry heart rate cerebral perfusion pressure cerebral oximetry levels records of all patients were taken as baseline values before the operation During the operation serum samples were taken and 5 ml blood samples were taken from the artery peripheral and 5 ml from the vena jugularis interna during the operation Blood samples were immediately centrifuged at 15000 rpm for 15 minutes and the supernatant was collected The supernatant was immediately stored at -80 C for further analysis of oxidative stress and other parameters The parameters studied are Human NSENeuron Specific Enolase ELISA Kit Neuron Specific Enolase ELISA Kit Human S100B S100 Calcium Binding Protein B ELISA Kit HIF-1α Hypoxia Inducible Factor 1 Alpha ELISA Kit Human DAFDecay Accelerating Factor ELISA Kit
A General anesthesia procedure Anesthesia induction was performed with 1-2 mgkg propofol 1 mcgkg fentanyl 05 mgkg rocuronium Anesthesia was maintained with remifentanil infusion 005-01 mcgkgmin 1-2 sevoflurane 1 MAC and rocuronium Mechanical ventilation parameters were adjusted to be within the limits of end-tidal carbon dioxide normocarby 35-45mm Hg mean 40 mmHg To prevent the development of bradycardia 1 lidocaine was applied to the internal external and common carotid arteries by the surgical team Following systemic intravenous 5000 IU heparin administration carotid arterial cross-clamp was placed with appropriate active clotting time 200 B Superficial and deep cervical blockade It was done with 05 isobaric bupivacaine 15 ml 2 prilocaine 5 ml
ΔrSO2 100 x rSO2preclamping - rSO2baseline rSO2baseline Baseline rSO2 value rSO2 measurement for each specific time point and rSO2 change between them were continuously monitored by oximetry Invos System 4100 Somonetics Corporation Troy MI USA The entire CEA surgical procedure was performed with the standardized technique in these 6 patients
In the analysis phase the patients were evaluated in 2 groups Group 1 Basal cerebral oximetry levels between 41-60 Group 2 Basal cerebral oximetry levels 61
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None