ANZCTR - Registration

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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 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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Postoperative Cognitive Dysfunction

Carotid stenosis

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Diagnosis / Prognosis

Intervention code [2]

Early Detection / Screening

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Brain oxygen rSO2 levels were measured using near-infrared spectroscopy (NIRS) monitor

Timepoint [1]

During the operation and 2 days after the operation

Secondary outcome [1]

Intraoperative hemodynamic changes were observed during the cross-clamp bedside hemodynamic monitor.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Cengiz Sahutoglu

Address [1]

Dr. Cengiz Sahutoglu
Ege University School of Medicine
Department of Anesthesiology and Reanimation
Bornova/Izmir, Turkey

Country [1]

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]

Individual

Name [1]

Aslan Zafer Atilgan

Address [1]

Dr. Aslan Zafer Atilgan
Ege University School of Medicine
Department of Anesthesiology and Reanimation
Bornova/Izmir, Turkey

Country [1]

Turkey

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ege University Faculty of Medicine Clinical Research Ethics Committee

Ethics committee address [1]

Ege University Faculty of Medicine Clinical Research Ethics Committee
Ege Üniversitesi Tip Fakültesi Dekanligi, 35100, Bornova, Izmir

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

07/04/2017

Approval date [1]

06/04/2018

Ethics approval number [1]

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

Dr Cengiz Sahutoglu

Address

Dr. Cengiz Sahutoglu
Ege University School of Medicine
Department of Anesthesiology and Reanimation
Bornova/Izmir, Turkey

Country

Turkey

Phone

+905064248814

Fax

csahutoglu@yahoo.com

Contact person for public queries

Name

Aslan Zafer Atilgan

Address

Dr. Aslan Zafer Atilgan
Ege University School of Medicine
Department of Anesthesiology and Reanimation
Bornova/Izmir, Turkey

Country

Turkey

Phone

+902323902140

Fax

aslan_zafer@yahoo.com

Contact person for scientific queries

Name

Aslan Zafer Atilgan

Address

Dr. Aslan Zafer Atilgan
Ege University School of Medicine
Department of Anesthesiology and Reanimation
Bornova/Izmir, Turkey

Country

Turkey

Phone

+902323902140

Fax

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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