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临床试验/NCT02771418
NCT02771418已完成不适用

The Effects of Anaesthesia on Cerebral Oxygenation and Cognitive Function in Carotid Endarterectomy

Northern State Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Early postoperative cognitive dysfunction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • > 18 years
  • Male gender
  • Informed consent
  • Symptomatic carotid stenosis > 75%

排除标准

  • Contralateral carotid occlusion
  • Known allergy to the one of the compared medications

研究组 & 干预措施

TIVA with propofol

Sham Comparator

Induction and maintenance of general anesthesia using TIVA with propofol

干预措施: Propofol (Drug)

TIVA with propofol

Sham Comparator

Induction and maintenance of general anesthesia using TIVA with propofol

干预措施: Elective carotid endarterectomy (Procedure)

VIMA with sevoflurane

Active Comparator

Induction and maintenance of general anesthesia using VIMA with sevoflurane

干预措施: Sevoflurane (Drug)

VIMA with sevoflurane

Active Comparator

Induction and maintenance of general anesthesia using VIMA with sevoflurane

干预措施: Elective carotid endarterectomy (Procedure)

结局指标

主要结局

Early postoperative cognitive dysfunction

时间窗: 5 Days of the perioperative period

Postoperative cognitive dysfunction assessed with MoCA score

次要结局

  • Cerebral desaturation(0-20 hrs of the perioperative period)

研究者

发起方
Northern State Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vsevolod V. Kuzkov

MD, PhD

Northern State Medical University

研究点 (1)

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