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临床试验/NCT03957018
NCT03957018Unknown不适用

Temporal Profile of Biomarkers Associated to Perioperative Stress Due to Carotid Endarterectomy Under Regional Anesthesia

University of Pecs1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年11月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
major vascular events

研究概览

简要总结

Carotid endarterectomy (CEA) is a high risk surgical and anesthesiological procedure. It is an essential part of stroke-prevention strategies, however the incidence of CEA related peri-operative stroke is between 5% and 10%. These procedures can be performed either in general or regional anaesthesia. We hypothesized that an appropriate awake sedation is able to decrease patient's distress and an improved satisfaction can be reached.

详细描述

We aim to explore the stress response of patients randomized according to different sedation protocols: (i) per os premedication only with alprazolam (BDZ group) or (ii) premedication with alprazolam combined with target control infusion (TCI) of propofol (BDZ+TCI) for awake carotid endarterectomy. A total of 50 consecutive patients with significant carotid artery stenosis will be enrolled into this prospective randomised study. All surgeries will be performed in regional anaesthesia. As premedication, all patients took 0.25 mg alprazolam 30 minutes before the procedure. After randomization 25 patients will be grouped to both arms of the study: either to "sedation with target controlled propofol infusion", or to "only premedication". Stress markers, such as cortisol plasma levels will be serially analysed: prior to surgery (T1), before (T2) and after release of carotid clamp (T3), at 2 (T4) and 24 post-operative hours (T5). Alprazolam levels were also measured before and after the surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with significant symptomatic or asymptomatic carotid stenosis scheduled for carotid endarterectomy, written informed consent -

排除标准

  • patient declines to participate in the study

结局指标

主要结局

major vascular events

时间窗: at 30th postoperative day

acute coronary syndrome, myocardial infarction, stroke, transient ischemic attack

次要结局

  • mortality and vascular events(5-year follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tihamér Molnár

associate professor

University of Pecs

研究点 (1)

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