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CompletedNCT05652426Updated Dec 15, 2022

The Effect of Hypoxic and Normoxic Cerebral Oximetry Levels on Cognitive Functions After Carotid Endarterectomy

An observational study in Cerebral Hypoxia, Carotid Stenosis and Cognitive Dysfunction, sponsored by Duzce University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-15.

Sponsored by Duzce University · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
6
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

Read the 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 clamp(from 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 NSE(Neuron 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 DAF(Decay Accelerating Factor) ELISA Kit.

A. General anesthesia procedure: Anesthesia induction was performed with 1-2 mg/kg propofol, 1 mcg/kg fentanyl, 0.5 mg/kg rocuronium. Anesthesia was maintained with remifentanil infusion (0.05-0.1 mcg/kg/min), 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 0.5% 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%

02

Conditions studied

  • Cerebral Hypoxia
  • Carotid Stenosis
  • Cognitive Dysfunction
03

In context

Hypoxia, Brain

81 studies on the registry are indexed under Hypoxia, Brain; 19 are open to participants now.

This study's enrollment of 6 is below the median of 60 across 25 observational studies indexed under Hypoxia, Brain.

Browse Hypoxia, Brain studies →

Lead sponsor

Duzce University is the lead sponsor of 76 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients who were scheduled for carotid endarterectomy, examined the MOCA (Montreal cognitive assesment )tests before and after the operation and collected blood samples intraoperatively .

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
6 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 1

    Basal cerebral oximetry levels between 41-60%

  • Group 2

    Basal cerebral oximetry levels \> 61%

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 day

Secondary outcomes

  1. 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.

    Time frame: 7 day

  2. 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.

    Time frame: 7 day

07

Study locations

1 site
  • İlknur Suidiye Yorulmaz
    Düzce, 81620, Turkey
08

References and documents

Publications

  • 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. PubMed 11843692 ↗
  • Zhang HP, Ma XD, Chen LF, Yang Y, Xu BN, Zhou DB. Cognitive Function After Carotid Endarterectomy: Early Decline and Later Recovery. Turk Neurosurg. 2016;26(6):833-839. doi: 10.5137/1019-5149.JTN.13382-14.1. PubMed 27438617 ↗
  • 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. PubMed 28872355 ↗
  • Koh MY, Powis G. Passing the baton: the HIF switch. Trends Biochem Sci. 2012 Sep;37(9):364-72. doi: 10.1016/j.tibs.2012.06.004. Epub 2012 Jul 18. PubMed 22818162 ↗
  • Schmid T, Zhou J, Brune B. HIF-1 and p53: communication of transcription factors under hypoxia. J Cell Mol Med. 2004 Oct-Dec;8(4):423-31. doi: 10.1111/j.1582-4934.2004.tb00467.x. PubMed 15601571 ↗
  • Lee JW, Bae SH, Jeong JW, Kim SH, Kim KW. Hypoxia-inducible factor (HIF-1)alpha: its protein stability and biological functions. Exp Mol Med. 2004 Feb 29;36(1):1-12. doi: 10.1038/emm.2004.1. PubMed 15031665 ↗
  • Hashimoto T, Shibasaki F. Hypoxia-inducible factor as an angiogenic master switch. Front Pediatr. 2015 Apr 24;3:33. doi: 10.3389/fped.2015.00033. eCollection 2015. PubMed 25964891 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2021 to primary completion in Jan 2022, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 7, 2022
First posted
Dec 15, 2022
StartActual
Jan 1, 2021
Primary completionActual
Jan 1, 2022
CompletionActual
Jan 1, 2022
Last update
Dec 15, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05652426
Lead sponsor
Duzce University
Responsible party
Sponsor
First posted
Dec 15, 2022
Start date
Jan 1, 2021
Primary completion
Jan 1, 2022
Completion
Jan 1, 2022
Last update
Dec 15, 2022

Study contacts

İlknur S Yorulmaz
principal investigator · Duzce University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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