Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000741684
Ethics application status
Approved
Date submitted
31/05/2023
Date registered
10/07/2023
Date last updated
10/07/2023
Date data sharing statement initially provided
10/07/2023
Date results information initially provided
10/07/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Changes in tissue oxygenation in carotid occlusion
Scientific title
The Relationship Between Cerebral Desaturation and Postoperative Cognitive
Dysfunction in Carotid Endarterectomy Surgery: A Prospective Study
Secondary ID [1] 309797 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Cognitive Dysfunction 330206 0
Carotid stenosis 330207 0
Condition category
Condition code
Anaesthesiology 327076 327076 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Days
Description of intervention(s) / exposure
A Standardized Mini Mental Test was administered to determine the baseline cognitive function level of the patients 24 hours before the operation. Patients admitted to the operating room underwent electrocardiography (ECG), peripheral oxygen saturation (SpO2), invasive blood pressure monitoring (radial artery), esophageal temperature measurement, and Near-Infrared Spectroscopy (NIRS) monitoring. Arterial blood pressure (systolic/diastolic/mean), heart rate (HR), oxygen saturation (SatO2), and cerebral tissue oxygen saturation (rSO2) on the operative side and contralateral side were
noted in the case form at baseline (T1), 5 minutes after intubation (T2), before carotid clamping (T3), the 5th (T4) and 10th (T5) minutes after carotid clamping, 5th minutes after unclamping (T6), preextubation (T7), and the end of the operation (T8). Two days
after the operation, the mini-mental test was repeated by the same physician.
Cerebral desaturation was defined as a decrease of 25% or more in the baseline value of near-infrared spectroscopy (NIRS) or an NIRS value below 50%. The patients were divided into two groups: group I included those who experienced cerebral desaturation, and group II consisted of those who did not experience desaturation (normal group). Demographic data, NIRS values, complications, and changes in the mini-mental test were analyzed to determine if there were significant statistical differences between the two groups.
The same physician performed the Standardized Mini Mental Test and took around 20 minutes to complete.
Intervention code [1] 326226 0
Diagnosis / Prognosis
Intervention code [2] 326227 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334940 0
Brain oxygen rSO2 levels were measured using near-infrared spectroscopy (NIRS) monitor
Timepoint [1] 334940 0
During the operation and 2 days after the operation
Secondary outcome [1] 422490 0
Intraoperative hemodynamic changes were observed during the cross-clamp bedside hemodynamic monitor.
Timepoint [1] 422490 0
During the cross-clamp

Eligibility
Key inclusion criteria
The patients who underwent carotid endarterectomy due to carotid stenosis
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with communication problems, illiteracy, and inability to
complete the tests successfully, sedative, antidepressant, or antiepileptic medication use,
cerebrovascular or psychiatric diseases, and alcohol or substance dependence were excluded from the study.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical calculations were performed using SPSS 21.0 software (SPSS Inc., IL, USA) for Windows. The data were expressed as mean ± standard deviation (SD), median, and percentage (%). The Kolmogorov-Smirnov test was used to determine the normal distribution. Chi-square and Fisher's exact tests were used for categorical variables in intergroup comparisons, while independent samples t-test and Mann-Whitney U test were used for numerical variables. For repeated measurements, ANOVA (Bonferroni test) was applied. A p-value of <0.05 was considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/04/2018
Date of last participant enrolment
Anticipated
Actual
12/10/2018
Date of last data collection
Anticipated
Actual
30/10/2018
Sample size
Target
75
Accrual to date
Final
48
Recruitment outside Australia
Country [1] 25565 0
Turkey
State/province [1] 25565 0

Funding & Sponsors
Funding source category [1] 313979 0
Self funded/Unfunded
Name [1] 313979 0
Cengiz Sahutoglu
Country [1] 313979 0
Turkey
Primary sponsor type
Individual
Name
Cengiz Sahutoglu
Address
Dr. Cengiz Sahutoglu
Ege University School of Medicine
Department of Anesthesiology and Reanimation
Bornova/Izmir, Turkey
Country
Turkey
Secondary sponsor category [1] 315853 0
Individual
Name [1] 315853 0
Aslan Zafer Atilgan
Address [1] 315853 0
Dr. Aslan Zafer Atilgan
Ege University School of Medicine
Department of Anesthesiology and Reanimation
Bornova/Izmir, Turkey
Country [1] 315853 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313117 0
Ege University Faculty of Medicine Clinical Research Ethics Committee
Ethics committee address [1] 313117 0
Ege University Faculty of Medicine Clinical Research Ethics Committee
Ege Üniversitesi Tip Fakültesi Dekanligi, 35100, Bornova, Izmir
Ethics committee country [1] 313117 0
Turkey
Date submitted for ethics approval [1] 313117 0
07/04/2017
Approval date [1] 313117 0
06/04/2018
Ethics approval number [1] 313117 0
18-4/36

Summary
Brief summary
Introduction: Carotid endarterectomy (CEA) is an established surgical procedure for
patients with high-grade carotid artery stenosis. Cerebral hypoperfusion after clamping
the carotid artery can lead to the development of new strokes or worsen existing
damage. Near-infrared spectroscopy (NIRS) provides continuous and non-invasive
monitoring of cerebral oxygenation, allowing for early detection of cerebral ischemia
due to hypoperfusion in critical patients and a reduction in early complications.
Postoperative cognitive dysfunction (POCD) refers to changes in cognitive function
following surgery and anesthesia.
Methods: In this prospective and observational study, our aim is to evaluate whether
cerebral desaturation, as assessed by NIRS, contributes to the occurrence of POCD.
Hemodynamic and NIRS assessments were recorded at various time points: baseline,
post-intubation, pre-clamping, 5th and 10th minutes after carotid clamping, 5th minutes
after unclamping, pre-extubation, and the end of the operation. The Mini-Mental Status
Examination was administered to patients on the day before surgery and on the
second day after surgery.
Results: Cerebral desaturation was observed in 33% of patients. Regional cerebral
oxygen saturation (rSO2) showed a slight decrease in the early stages after clamping
the carotid artery. During the clamping period, rSO2 values increased, and by the end
of the operation, they had returned to baseline or even exceeded baseline levels. We
did not identify any cases of POCD during the early postoperative period.
Conclusion: NIRS is a practical and effective method for detecting cerebral
hypoperfusion. However, based on our study, we were unable to establish a correlation between NIRS values and the occurrence of POCD
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127054 0
Dr Cengiz Sahutoglu
Address 127054 0
Dr. Cengiz Sahutoglu
Ege University School of Medicine
Department of Anesthesiology and Reanimation
Bornova/Izmir, Turkey
Country 127054 0
Turkey
Phone 127054 0
+905064248814
Fax 127054 0
Email 127054 0
csahutoglu@yahoo.com
Contact person for public queries
Name 127055 0
Dr Aslan Zafer Atilgan
Address 127055 0
Dr. Aslan Zafer Atilgan
Ege University School of Medicine
Department of Anesthesiology and Reanimation
Bornova/Izmir, Turkey
Country 127055 0
Turkey
Phone 127055 0
+902323902140
Fax 127055 0
Email 127055 0
aslan_zafer@yahoo.com
Contact person for scientific queries
Name 127056 0
Dr Aslan Zafer Atilgan
Address 127056 0
Dr. Aslan Zafer Atilgan
Ege University School of Medicine
Department of Anesthesiology and Reanimation
Bornova/Izmir, Turkey
Country 127056 0
Turkey
Phone 127056 0
+902323902140
Fax 127056 0
Email 127056 0
aslan_zafer@yahoo.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator
(Aslan Zafer Atilgan: aslan_zafer@yahoo.com)


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.