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临床试验/NCT02450734
NCT02450734已完成不适用

Safety and Efficiency of Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Surgery

Institut Mutualiste Montsouris1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
quality of anesthesia

研究概览

简要总结

Since stroke and myocardial ischemia are major causes of perioperative morbidity and mortality associated with carotid endarterectomy, monitoring the brain and ensuring the best hemodynamic stability are important goals of perioperative management.

The investigators conducted a prospective observational study about efficacy and safety of the ultrasound-guided intermediate cervical plexus block (CPB), with early (immediate postoperative) and mid-term (day 30) outcomes in awake patients undergoing carotid endarterectomy.

详细描述

From April 2011 to May 2013, all patients undergoing a carotid endarterectomy were informed of the study and prospectively included. The study was approved by our institutional ethical Review Board (CEPAR, Institut Mutualiste Montsouris Paris France). Oral consent was obtained from patients. Written informed consent of the patients to participate was not necessary according to the French law regarding observational study.

The anesthesiologist in charge of the patient recorded all the parameters of the ultrasound-guided intermediate cervical plexus block: facility and duration of block performance, local anesthetic volume, quality of anesthesia and surgical dissection, and adverse effects of the intermediate CPB. . Neurological status was assessed intraoperatively, in the postoperative setting and at one month after the procedure. Perioperative hemodynamic stability (intraoperative non invasive blood pressure variations) and pulse oxymetry were recorded. As well as ECG and cardiac Troponin I (cTnI) measurments performed the day before surgery and each morning during the 3 first postoperative days. Any clinical coronary or neurological event was recorded at one month.

Statistical analysis was performed on Prism 6 for Mac OS X (Version 6.0c, www.graphpad.com). Data are presented as mean ± standard deviation (SD) for continuous data and number (percentage) for categorical data.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Patients undergoing carotid endarterectomy

排除标准

  • 未提供

结局指标

主要结局

quality of anesthesia

时间窗: immediate

assessed by the patient (quality scale) and absence of the need to general anesthesia

次要结局

  • Hemodynamic stability(immediate during surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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