Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury - A Randomized Control Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Mean arterial blood pressure (MAP)
研究概览
简要总结
The standard of care for treatment of burn injury is to inject a solution of epinephrine under the skin of the injured site in order to reduce blood loss during skin grafting. This solution of epinephrine has been shown to have effects on the body outside the donor site. Some people have increases in heart rate and blood pressure. We will study the effect of a phenylephrine solution in place of an epinephrine solution to control blood loss. We think that phenylephrine will help decrease blood loss and not change blood pressure or heart rate.
The injured area will be injected under the skin and a skin graft will be taken in the same way as we usually do. The only change will be the use of phenylephrine in the solution instead of epinephrine.
Our goal is to find whether or not phenylephrine or epinephrine solution results in a reduction of blood loss without affecting the rest of the body.
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
- All
- 接受健康志愿者
- 否
入选标准
- •a) Burn injury requiring debridement and grafting between 5-30% TBSA
排除标准
- •Head and neck, hand, foot, or genital burns
- •On anticoagulants (except NSAIDs)
- •On monoamine oxidase inhibitor or tricyclic antidepressant
- •Coronary or peripheral vascular disease
- •History of arrhythmias
- •On a Beta-blocker
- •History of vascular abnormality
- •Hypertension
研究组 & 干预措施
Epinephrine
1:1000000
干预措施: Phenylephrine (Drug)
Phenylephrine
20 ug/cc
干预措施: Phenylephrine (Drug)
结局指标
主要结局
Mean arterial blood pressure (MAP)
时间窗: during first 30 minutes
Mean arterial blood pressure
次要结局
- Heart Rate(q15 min)
- Blood Pressure(q15 min)