Effects of Norepinephrine vs. Phenylephrine on the Graft Blood Flow Measured by Transit Time Flowmetry in Breast Reconstruction With Free Flap Transfer Surgery: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Graft mean blood flow measured using transit time flowmetry
研究概览
简要总结
The purpose of this pilot study is to investigate whether two major vasopressors (norepinephrine vs. phenylephrine) used for treatment of hypotension during breast reconstruction with free flap transfer surgery have different effects on blood flow of the flap vessel measured by transit time flowmetry. Since there are few prior studies that compared the effects of these two vasopressors on the blood flow of the flap, this study will be conducted in the form of a pilot study in order to establish the evidence for the future randomized controlled trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA Physical Status Classification Grade 1-3
- •Patients with an ECOG score of 0 or 1 when selecting a subject for the study
- •Patients who can provide written consent to participate in clinical trials
- •Patients requiring the use of vasopressor because the mean arterial pressure is not maintained more than 65 mmHg during surgery
排除标准
- •Patients with peripheral arterial diseases
- •Patients with allergic history to study drugs
- •If surgery on other areas is scheduled at the same time or is an emergency operation
- •Patients with history of previous abdominal surgery involving the flap donor site
- •If there are other major medical or psychiatric disorders that may affect treatment response
- •Left ventricular ejection fraction < 30% or with a history of arrhythmia that is not controlled by medication
- •Refuse to participate
研究组 & 干预措施
Norepinephrine
Norepinephrine Bitartrate Hydrate : 4 mg/4 mL
干预措施: Norepinephrine (Drug)
Phenylephrine
Phenylephrine hydrochloride : 10 mg/1 mL
干预措施: Phenylephrine (Drug)
结局指标
主要结局
Graft mean blood flow measured using transit time flowmetry
时间窗: Intraoperative period
Mean blood flow (in mL/min) of the graft vessel that was measured using transit time flowmetry
Pulsatility of graft vessel measured using transit time flowmetry
时间窗: Intraoperative period
Pulsatility of graft vessel, which is presented as pulsatility index in unitless, that was measured using transit time flowmetry
Diastolic filling of the graft vessel measured using transit time flowmetry
时间窗: Intraoperative period
Diastolic filling (in percentage) of the graft vessel that was measured using transit time flowmetry
次要结局
- Total amount of remifentanil infused during surgery in patients received each vasopressor(intraoperative period)
- Serum lactate levels in patients received each vasopressor(Within seven days after surgery)
- Total amount of inotropic agents or vasopressor during surgery in patients received each vasopressor(intraoperative period)
- Stroke volume during surgery in patients received each vasopressor(intraoperative period)
- Cardiac index during surgery in patients received each vasopressor(intraoperative period)
- Capillary filling time in patients received each vasopressor during surgery(Within seven days after surgery)
- Skin necrosis rate in patients received each vasopressor during surgery(Within seven days after surgery)
- Rate of wound infection or any wound problem in patients received each vasopressor during surgery(Within seven days after surgery)
- Amount of transfusion in patients received each vasopressor during surgery(Within seven days after surgery)
- Graft failure rate in patients received each vasopressor during surgery(Within seven days after surgery)
- Rate of vascular thrombosis in patients received each vasopressor during surgery(Within seven days after surgery)
- Stroke volume variation during surgery in patients received each vasopressor(intraoperative period)
- Wound exploration rate in patients received each vasopressor during surgery(Until discharge)
- Reoperation rate in patients received each vasopressor during surgery(Until discharge)
研究者
Youn Joung Cho, MD, PhD
Seoul National University Hospital
Seoul National University Hospital