The Effect of Subcutaneous Nitroglycerin on the Success Rate of Arterial Catheterization in Pediatric Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- First attempt success rate
研究概览
简要总结
The primary objective of the study is to evaluate the vasodilative effect of subcutaneous nitroglycerin during ultrasound-guided radial artery cannulation in pediatric patients. The hypothesis of this study is that the subcutaneous nitroglycerin will increase the radial artery size and improve the first-attempt success rate of radial artery cannulation. This is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of subcutaneous nitroglycerin and saline on radial artery cannulation in pediatric patients undergoing general anesthesia. Prior to the procedure, each patient will be randomized into either the control arm, saline, or study arm, nitroglycerin.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General anesthesia
- •Arterial cannulation for hemodynamic monitoring, multiple blood sample
排除标准
- •Hypersensitivity or contraindication to nitroglycerine
- •Unstable vital sign, significant arrhythmia or hypotension, Shock
- •High risk of peripheral ischemia
- •Skin disease, infection, hematoma, recent cannulation at radial artery.
- •Increased intracranial pressure, Intracranial hemorrhage
- •Recent use of PDE5 inhibitors (<24 hours after sildenafil or vardenafil; <48 hours after tadalafil)
研究组 & 干预措施
Control
Normal saline (0.5cc) is subcutaneously injected before radial artery cannulation.
干预措施: Normal saline (Drug)
Nitroglycerin
Nitroglycerin 5mcg/kg (0.5cc) is subcutaneously injected before radial artery cannulation.
干预措施: Nitroglycerin (Drug)
结局指标
主要结局
First attempt success rate
时间窗: During radial artery cannulation (up to 1 hour)
Success at the first skin puncture
次要结局
- Overall success rate(During radial artery cannulation (up to 1 hour))
- Overall Procedure time(During radial artery cannulation (up to 1 hour))
- Size of radial artery(Before and after subcutaneous injection of drugs (up to 1 hour))
- Overall attempt(During radial artery cannulation (up to 1 hour))
- depth of radial artery(Before and after subcutaneous injection of drugs (up to 1 hour))
- Malfunction of radial artery catheter(After radial artery cannulation assessed during anesthesia (up to 24 hour))
- Complication rate(After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 48 hour))
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital