NCT01905501已完成不适用
Sevoflurane Protective Effect on Ischemia-reperfusion Injury in Patients Undergoing Reconstructive Plastic Surgery With Microsurgical Flap. Multicenter, Randomized Controlled Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- continuous tissue oximetry (NIRS)
研究概览
简要总结
This study aimed to evaluate the possible protective effect of anesthetic technique balanced(with sevoflurane) compared with total intravenous anesthetic technique (propofol,remifentanil). The hypothesis is that the Sevoflurane may exert protective effect in regard to the ischemia-reperfusion injury induced on the microsurgical breast free flap during transfer to receiving area. The investigators will evaluate the continuous flap tissue oximetry and the level of biochemical markers.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient selected for plastic breast surgery With microsurgical Free flap Over 18 y Asa I/II
排除标准
- •Unusual reaction to anesthetic drugs Suspect for malignant hyperthermia Vasculopathic disease Coagulation disease
研究组 & 干预措施
Total intravenous anesthesia
Active Comparator
Total intravenous anaesthesia
干预措施: Total intravenous anesthesia (Drug)
Balanced anesthesia
Experimental
干预措施: Balanced anesthesia (Drug)
结局指标
主要结局
continuous tissue oximetry (NIRS)
时间窗: 20 hours
次要结局
- Biochemical Markers(Preoperative and 24 hours post operative)
- Lactate Clearance(24 hours)
研究者
Ester Forastiere
M.D., Chief of Critical Area Department
Regina Elena Cancer Institute
研究点 (1)
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