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CAROTID ENDATORECTOMY AND GENERAL ANESTHESIA: Assessment and Evaluation of Cerebral Ischemic Damage With Clinical, Laboratory and Imaging Parameters

18. maj 2026 opdateret af: Athanasia Voulgari, University Hospital of Patras

CAROTID ENDATORECTOMY AND GENERAL ANESTHESIA: Assessment and Evaluation of Cerebral Ischemic Damage With Clinical, Laboratory and Imaging Parameters: a Single-center, Prospective, Randomized, Comparative Clinical Study

This study is aiming to provide us with information about the neuroprotective effect of two commonly used anesthetic drugs, during carotid endarterectomy. A day before sugery, a brain MRI will be performed as well as a cognitive function assessment test. The day of the surgery each patient will receive anesthesia either by using intravenous anesthetic drug or an inhalation agent and during the intraoperative period, the Anesthesiologist will draw a small amount of blood in three different times in order to measure brain biomarkers. A day after the surgery, a second brain MRI will be performed as well as a second cognitive function assessment test and their results will be compared to the preoperative ones. The study will focus on whether there is a higher incidence of microischemic brain lesions shown in imaging tests or whether cognitive function is impaired postoperative or whether brain biomarkers indicating brain damage are elevayed with any of these drugs and thus conclude which one shows or not a neuroprotective effect, with the condition that no change in the regular anesthesia management was made and no danger was imposed on the patient.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Carotid endarterectomy is a surgical procedure with special perioperative and postoperative requirements and potential major adverse events, which can occur rapidly and be life threatening, and compromise the functional and neuropsychiatric integrity of the patient. Stroke is the most frequent major complication both in the intraoperative and immediate postoperative period. The Anesthesiologist is required to ensure adequate cerebral circulation and oxygenation through the close regulation of hemodynamic parameters and the continuous monitoring of cerebral oximetry, with the aim of preventing the occurrence and establishment of cerebral ischemic lesions.

The purpose of this study is to compare two anesthetic drugs (propofol and sevoflurane) during the maintenance of anesthesia in terms of their potential neuroprotective effect, which will be documented through clinical (gross neurological examination and MoCA test), laboratory (neuronal specific enolase NSE and human calcium-binding protein S100B) and imaging (MRI-diffusion) tests, which have proved to have high sensitivity and specificity for the early detection of ischemic brain lesions and cognitive deficits.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

160

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients who are 18 or over 18 years old and come to the hospital for planned carotid endarterectomy and do not have major neurological deficits prior to surgery

Beskrivelse

Inclusion Criteria:

  • Age ≥ 18 years
  • ASA 1-4
  • For planned carotid endarterectomy
  • Absence of major established neurological deficits that would not allow neurological evaluation and performance of the MoCA test
  • Patient consent to participate in the study

Exclusion Criteria:

  • Age ≤ 18 years
  • Presence of major neurological deficits that will not allow neurological evaluation and performance of the MoCA test
  • Claustrophobia and inability to enter the MRI scanner
  • Cochlear implants
  • Intracranial vascular clips
  • Neurostimulation systems
  • Pacemaker incompatible for MRI
  • Small cell and non-small cell lung cancer
  • Neuroendocrine tumors
  • Melanoma
  • Seminoma
  • Teratoma
  • Malignant pheochromocytoma
  • CNS or NM diseases
  • Schizophrenia
  • Allergy or contraindication to any anesthetic factor
  • Patient refusal to participate in the study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
group propofol
Anesthesia will be preserved using propofol in the patients of this group
Diagnostisk test: MRI
MRI diffusion and cognitive function assessment tests will be performed prior to surgery and postoperatively 24 hours after the end of the surgery so as any new brain lesion to be detected.
Andre navne:
  • biomarkører
  • Cognitive function assessment test
  • brain biomarkers
  • alderte test
Medicin: Propofol (Astra-Zeneca)
neuroprotection provided by either sevoflurane or propofol using laboratory, clinical and imaging tests and scores such as alderte score during awakening
Diagnostisk test: biomarkers
Brain biomarkers will be measured prior to artery clampring, 15 minutes after the artery clamping and 15 minutes after the end of surgery
group sevoflurane
Anesthesia will be preserved using sevoflurane in the patients of this group
Diagnostisk test: MRI
MRI diffusion and cognitive function assessment tests will be performed prior to surgery and postoperatively 24 hours after the end of the surgery so as any new brain lesion to be detected.
Andre navne:
  • biomarkører
  • Cognitive function assessment test
  • brain biomarkers
  • alderte test
Medicin: Propofol (Astra-Zeneca)
neuroprotection provided by either sevoflurane or propofol using laboratory, clinical and imaging tests and scores such as alderte score during awakening
Diagnostisk test: biomarkers
Brain biomarkers will be measured prior to artery clampring, 15 minutes after the artery clamping and 15 minutes after the end of surgery

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
new microischemic brain lesions
Tidsramme: 24 hours preoperative to 24 hours postoperative
Number of participants with any silent brain lesions or brain lesions accompanied with cognitive dysfunction postoperatively
24 hours preoperative to 24 hours postoperative
neuroprotective effect
Tidsramme: from 24 hours prior to surgery to 24 hours after the surgery
The group of patients that has the fewer adverse events as assessed clinically or with laboratory and imaging tests will be considered to receive the most neuroprotective anesthetic agent
from 24 hours prior to surgery to 24 hours after the surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital of Patras

Efterforskere

  • Studiestol: ADAMANTIA ARETHA, PROFESSOR OF ANESTHESIOLOGY, University Hospital of Patras

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. maj 2026

Primær færdiggørelse (Anslået)

1. september 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

5. maj 2026

Først indsendt, der opfyldte QC-kriterier

18. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 379/7-10-2025

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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