NCT02555046Unknown不适用
Muscle and Cerebral Oxygenation Under Endovascular Aortic Repair (EVAR) of Abdominal Aortic Aneurysm: General Versus Local Anesthesia - an Randomised Controlled Trial Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 26
- 主要终点
- Near-Infrared Spectroscopy-determined Muscle oxygenation
研究概览
简要总结
The purpose of this study is to determine the effect of General versus Local Anaesthesia on muscle and cerebral oxygenation under EVAR-treatment in a prospective unblinded randomised controlled trail.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •18 years or older
- •Scheduled procedure
排除标准
- •allergies for used local anaesthesia
- •have had vascular surgery before in the femoral area
- •the need for thromboendarterectomy in common femoral artery
- •the need for aortouniiliac stent-graft with cross-over bypass
- •severe back pain
- •expected time of surgery more than 1.5 hour
- •cognitive dysfunction making cooperation during procedure impossible
- •Femoral amputee
研究组 & 干预措施
General Anaesthesia
No Intervention
EVAR-treatment is preformed with the patient in General Anaesthesia
Local Anaesthesia
Experimental
EVAR-treatment is preformed with the patient in Local Anesthesia
干预措施: Local Anesthesia (Procedure)
结局指标
主要结局
Near-Infrared Spectroscopy-determined Muscle oxygenation
时间窗: participants will be followed for the duration of hospital stay, an expected average of 5 days
Near-Infrared Spectroscopy-determined Cerebral Oxygenation
时间窗: participants will be followed for the duration of hospital stay, an expected average of 5 days
次要结局
未报告次要终点
研究者
Mads Jacob Niemann
Medical Student
Rigshospitalet, Denmark
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