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临床试验/NCT06563557
NCT06563557尚未招募不适用

ERASME ULB: Erasme Randomized Controlled Trial Surveys Hemodynamic Excursions During Esophagectomy - a Double Blind Study

Erasme University Hospital0 个研究点目标入组 75 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
75
主要终点
Consumption of norepinephrine and fluids during procedure

研究概览

简要总结

In our high volume center, the majority of esophagectomy procedures are performed with minimally invasive techniques. The thoracic epidural technique remains the gold standard and homolateral paravertebral catheter is strongly recommended. The vasoplegia and sympathetic blockade due to the epidural can cause significant hypotension especially as reverse Trendelenburg position is required during surgery. The aim is to study hemodynamic changes caused by two different techniques. Previous studies found a similar pain management between both locoregional techniques, however few studies suggested less side effects in the paravertebral group during major abdominal surgeries.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Care Provider)

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

  • Adult, Capable of giving consent, two or three incisions esophagectomy (thoracoscopic/ thoracotomy) no laparotomy

排除标准

  • patient refusal, total language barrier, coagulation disorders, thrombocytopenia <75 000, contraindications to locoregional anesthesia (infection local site, allergy to local anesthesic), scoliosis Cobb > 45%, atrial fibrillation, end stage renal disease),

结局指标

主要结局

Consumption of norepinephrine and fluids during procedure

时间窗: 6 hours

norepinephrine mcg/kg/hr

次要结局

  • Postoperative complications(6 months)

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Sponsor

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