The Effect of Norepinephrine and Dopamine on Radial Forearm Free Flap Tissue Oxygen Pressure and Microdialysate Metabolite Measurements
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Evidence of clinically definite ischemia in a flap confirmed by changes in tissue oxygen pressure level and microdialysates metabolites
研究概览
简要总结
Vasopressors may be needed after head and neck microvascular reconstructions to maintain sufficient mean arterial pressure. This is crucial for the flap survival. The study hypothesis is that norepinephrine and dopamine used as vasopressors do not affect flap tissue oxygen level and microdialysate metabolites.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •head and neck cancer patients having tumor ablation surgery and reconstruction with microvascular radial forearm flap
排除标准
- •Patients having contraindications for the operation.
- •Patient refusal to participate in the study
研究组 & 干预措施
dopamine group
vasopressor dosage individually titred according to the mean arterial pressure
干预措施: Dopamine (Drug)
norepinephrine group
vasopressor dosage individually titred according to the mean arterial pressure
干预措施: Norepinephrine (Drug)
control group
no medication
干预措施: no medication (Other)
结局指标
主要结局
Evidence of clinically definite ischemia in a flap confirmed by changes in tissue oxygen pressure level and microdialysates metabolites
时间窗: 72 hours
次要结局
未报告次要终点
研究者
Minna Kääriäinen
MD, PhD, Senior Consultant, Associate Chief
Tampere University Hospital