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临床试验/NCT03907943
NCT03907943Unknown不适用

Assessment of Cognitive Function in Patients Undergoing Elective Carotid Endarterectomy

Semmelweis University Heart and Vascular Center2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年3月4日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
2
主要终点
Change in cognitive function after carotid endarterectomy

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • aged more than 18 years, undergoing elective carotid endarterectomy

排除标准

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

结局指标

主要结局

Change in cognitive function after carotid endarterectomy

时间窗: six months

Change in MMSE score after the carotid endarterectomy compared to baseline.

次要结局

未报告次要终点

研究者

发起方
Semmelweis University Heart and Vascular Center
申办方类型
Other
责任方
Sponsor

研究点 (2)

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