Randomized Trials of Epidural Combined With General Anesthesia Versus General Anesthesia Alone to Evaluate the Changes of Blood Flow in Arterial Anastomosis of Free Flap Using Duplex Ultrasonography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Maximal blood flow velocity
研究概览
简要总结
Comparing the changes of arterial anastomotic blood flow between general anesthesia alone and general anesthesia with epidural anesthesia in patients who undergoing free flap transposition using Duplex ultrasound.
详细描述
Maintaining adequate blood flow is important on the success of free flap surgery. Epidural anesthesia can influence blood flow during surgery. Therefore, investigators aim to compare the effect of epidural anesthesia combined with general anesthesia and general anesthesia alone on blood flow in arterial anastomosis site of the free flap.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo free flap transfer under general anesthesia.
- •18 years of age or older, under 80 years of age
- •Those who voluntarily agreed to participate in this clinical study
排除标准
- •If the patient does not agree to participate in the study
- •ASA physical status IV or higher
- •If the patient was diagnosed with diabetes
- •If the patient was diagnosed with chronic renal failure
- •If the patient was diagnosed with peripheral vascular disease or hyperlipidemia
- •If vasopressors or inotropics was used preoperatively.
- •Contraindication of epidural anesthesia such as usage of anticoagulant or abnormalities of laboratory finding.
- •If the researcher finds it to be inappropriate
研究组 & 干预措施
Epidural with general anesthesia
Epidural anesthesia with 0.2% ropivacaine 10 ml
干预措施: Epidural anesthesia (Other)
General anesthesia alone
Sevoflurane and nitrous oxide.
结局指标
主要结局
Maximal blood flow velocity
时间窗: 30 minutes after flap arterial anastomosis
Maximal blood flow velocity measured by using Duplex ultrasound
次要结局
- Arterial blood pressure(30 minutes after flap arterial anastomosis)
- Cardiac output(30 minutes after flap arterial anastomosis)
- Free flap failure(Day 7 after free flap surgery)
- Blood volume(30 minutes after flap arterial anastomosis)
- Pulse pressure variability(30 minutes after flap arterial anastomosis)
- Body temperature(30 minutes after flap arterial anastomosis)
- Arterial carbon dioxide concentration(30 minutes after flap arterial anastomosis)
研究者
Young-Kug Kim
Principal Investigator
Asan Medical Center