Effect of Papaverine on Intraoperative Renal Artery Blood Flow Volume in Patients Undergoing Robot-assisted Partial Nephrectomy : a Randomized, Placebo-controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Renal artery blood flow
研究概览
简要总结
The purpose of this study is to evaluate the effect of papaverine on renal artery blood flow after declamping of renal artery.
详细描述
The purpose of this study is to evaluate the effect of papaverine on renal artery blood flow after declamping of renal artery in patients undergoing robot assisted partial nephrectomy.
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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with kidney cancer.
- •Patients undergoing robot assisted partial nephrectomy under general anesthesia
- •20 years old ≤ age <80 years old
- •Patients who voluntarily agreed to this clinical study
- •eGFR ≥ 60 ml / min / 1.73 m2 (Chronic Kidney Disease Epidemiology Patients with Collaboration)
排除标准
- •The tumor ≥ 7 cm in size
- •Multiple renal mass
- •If the surgery plan is changed due to open
- •When surgery is performed together with other surgery
- •Multiple renal artery
- •Patients with hypersensitivity to papaverine
- •Patients with atrioventricular block
- •Pregnant and lactating women
- •Patients using levodopa
- •Refusal of patient
研究组 & 干预措施
Papaverine group
Immediately after the renal artery declamping, papaverine 30 mg (1 ample, 1 ml) is mixed with 5 ml of normal saline (total 6 ml) and sprinkled around the renal artery.
干预措施: Papaverine (Drug)
Normal saline group
Immediately after the renal artery declamping, normal saline 6 ml is sprinkled around the renal artery.
干预措施: Normal saline (Drug)
结局指标
主要结局
Renal artery blood flow
时间窗: at 2 minutes after papaverine administration
Renal artery blood flow 2 minutes after papaverine administration by doppler sonography
次要结局
- glomerular filtration rate using renal scan(at postoperative month 3)
- estimated glomerular filtration rate(at postoperative month 3)
研究者
Young-Kug Kim, MD
Principal Investigator
Asan Medical Center