An Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery: A Randomised Study
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
- Absolute change in transfer function (flap vascular resistance) after pressor infusion.
研究概览
简要总结
Following surgery to remove tumours of the head and neck, patients undergo reconstruction with free flaps - tissue that is taken from elsewhere in the body and given a new blood supply by attaching it to vessels in the neck. Following this type of surgery, patients often need medication to maintain their blood pressure in the intensive care unit. The effect of these drugs on the transplanted tissues is unknown. This study investigates the effects of four commonly used drugs on free flap perfusion.
详细描述
The optimal sympathomimetic drug to support blood pressure without adverse vasoconstriction of free flap circulation remains unknown. This study examined the effects of four agents (epinephrine, norepinephrine, dobutamine and dopexamine) on free flaps following resection of head and neck cancer.
Twenty five patients were recruited to the study. Each patient received an infusion of the four drugs in a random order with an intervening washout period between drugs, at four infusion rates. Continuous free flap skin blood flow monitoring was performed using laser Doppler velocimetry, with a second sensor on normal skin acting as a control. Global cardiovascular variables were monitored using the LiDCO Rapid pulse contour analysis system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing free tissue transfer surgery at the John Radcliffe Hospital wih planned post-operative admission to the intensive care unit.
排除标准
- •Pregnancy
- •Weight >100kg
- •Contraindications to pressor infusions
- •Overnight ventilation not indicated
研究组 & 干预措施
Pressors
Epinephrine, Norepinephrine, Dobutamine, Dopexamine
干预措施: Epinephrine (Drug)
Pressors
Epinephrine, Norepinephrine, Dobutamine, Dopexamine
干预措施: Norepinephrine (Drug)
Pressors
Epinephrine, Norepinephrine, Dobutamine, Dopexamine
干预措施: Dobutamine (Drug)
Pressors
Epinephrine, Norepinephrine, Dobutamine, Dopexamine
干预措施: Dopexamine (Drug)
结局指标
主要结局
Absolute change in transfer function (flap vascular resistance) after pressor infusion.
时间窗: Post infusion (at 4 hours)
次要结局
- Relative change in transfer function after pressor infusion compared with "normal" tissue.(Post infusion (at 4 hours))
- Change in flap flow after pressor infusion(Post infusion (at 4 hours))
- Differences in frequency spectrum of skin blood flow between flaps and "normal" tissue before and after pressor infusion.(Post infusion (at 4 hours))