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Assessment of Cognitive Function in Patients Undergoing Elective Carotid Endarterectomy

S

Semmelweis University

Status

Unknown

Conditions

Cognitive Impairment

Treatments

Procedure: carotid endarterectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT03907943
17/2019

Details and patient eligibility

About

Assessment of cognitive function in patients undergoing elective carotid endarterectomy

Classical treatment for ICA stenosis is carotid endarterectomy (CEA), which has been proven effective in preventing future stroke as well as improving cerebral perfusion. However, the influence of CEA on cognition is less defined, it remains unclear whether CEA can improve cognitive function. A change in cognition is one of the most threatening diseases of recent years, cognitive impairment significantly impacts patients, families, and healthcare system.

The difference in the cognitive outcome may be accounted for microembolic events and adverse changes in haemodynamic circumstances.

The aim of our study is to identify those factors what may have role in the postoperative cognitive decline.

The study was approved by the Ethical Committee of the university ( SE RKEB: 17/2019) and written informed consent will be obtained from all patients.

The investigators intend to enroll patient aged more than 18 years undergoing elective carotid endarterectomy at our hospital ( Semmelweis University Heart and Vascular Center). Exclusion criterion included young age (less than 18 years), incapacity and urgent surgery. The investigators would like to register at least 100-150 patients in our study.

Most relevant anamnestic dates, the results of the laboratory and radiological reports will be recorded. Cognitive functions will be assessed one day before, one day and six month after the surgery using MMSE and a questionnaire called Frailty to characterize beside cognitive function the physiological reserve of the patients too.

The investigators manage patients undergoing carotid endarterectomy with general anaesthesia, using inhaled or total intravenous agents.

During the operation the investigators record beside the routine monitoring (intraarterial blood pressure, ECG, oxygen saturation, EtCO2, MAC) the cerebral tissue oxygen saturation using a near-infrared cerebral oximeter (Invos Cerebral/Somatic Oximeter) and the activity of the brain using GE Entropy Module.

The investigators would like to register the changes in the haemodynamic and cerebral condition and compare these results against the clinical outcome and the changes of the questionnaires.

Statistical analyses will be performed using Statistical Package for the Social Sciences.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • aged more than 18 years, undergoing elective carotid endarterectomy

Exclusion criteria

  • younger than 18 years, incapacity, urgent surgery, lack of consent

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

Surgical treatment of carotid endarterectomy
Other group
Description:
The change in the cognitive function will be assessed in all patient undergoing carotid endarterectomy.
Treatment:
Procedure: carotid endarterectomy

Trial contacts and locations

1

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Central trial contact

Ágnes Sándor MD; Andrea Szekely MD, PhD, DEAA Associate Professor of Anesthesia

Data sourced from clinicaltrials.gov

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