Postoperative Cognitive Dysfunction Clinical Trial
Official title:
The Effects of Anaesthesia on Cerebral Oxygenation and Cognitive Function in Carotid Endarterectomy
Volatile anesthetics interfere with cerebral blood flow and reperfusion-ischemia injury via the mechanism known as a preconditioning. A transient deterioration of local hemodynamics and oxygenation during carotid endarterectomy (CEE) might involve both hemispheres of brain and affect postoperative cognitive function. The goal of this study was to assess the effects of anesthetics on perioperative cerebral oxygenation and cognitive functions.
Background: A transient deterioration of cerebral hemodynamics and oxygenation during CEE
might involve both hemispheres of the brain and affects postoperative cognition. Despite
some benefits of regional blocks, the majority of procedures of carotid endarterectomy (CEE)
are performed under general anaesthesia. Surprisingly, the studies comparing the effects of
sevoflurane and propofol on postoperative mental state in CEE are scarce and controversial.
While propofol possesses some anti-inflammatory properties, volatile anesthetics can
interfere with cerebral blood flow and reperfusion-ischaemia injury via the mechanism of
pre- and postconditioning. The goal of this study is to assess the effects of the
anesthetics on the perioperative cerebral oxygenation and cognitive functions in CEE.
Methods: The study and informed consent are approved by the Ethical Committee of the
Northern State Medical University. Forty patients (males only) who are to undergo elective
CEE will be included into a prospective study and randomised to two groups receiving either
total intravenous anaesthesia (TIVA group, propofol + fentanyl) or the volatile induction
and maintenance of anaesthesia (VIMA group, n = 20, sevoflurane + fentanyl). All patients
were operated using temporary carotid bypass. Invasive arterial pressure (AP), gas exchange,
and cerebral tissue oxygen saturation (SctO2, ForeSight, CAsMed, USA) over frontal region
for ipsilateral (SctO2IPSI) and contralateral (SctO2CONTR) hemispheres were registered
during the surgery and up to 20 hrs of the postoperative period. The cognitive changes will
be assessed at 12 hrs before as well as on Days 1 and 5 after CEE by blinded investigator
using Montreal Cognitive Assessment score (MoCA).
Data will be presented as median (25-75th percentiles). Intergroup comparison will be
provided with Mann-Whitney U-test and correlation analysis with Spearman's coefficient
(rho). P value below 0.05 was regarded as statistically significant.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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