The Effect of Nitroglycerin on the Incidence of Cardiorespiratory Side Effect During the Intra-arterial Chemotherapy in Pediatric Patients With Retinoblastoma: a Randomized, Double-blind, Placebo-controlled, Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The incidence of the cardio-respiratory side effects during ophthalmic artery selection and intra-arterial injection of chemotherapy agents. (percent)
研究概览
简要总结
The primary objective of the study is to evaluate the effect of intravenously infused nitroglycerin on the incidence of the cardio-respiratory side effects during the intra-arterial chemotherapy for retinoblastoma in pediatric patients.
The intra-arterial chemotherapy at the ophthalmic artery is an important treatment option for retinoblastoma. However, the cardio-respiratory side effects (sudden onset of bradycardia, hypotension, a severe decrease in the compliance of lung, hypoxia) occasionally occurs during catheter manipulation in the ophthalmic artery. One of the purported mechanisms of cardio-respiratory side effects is vagal activation from the activation of trigeminal ganglion by afferent signals from the ophthalmic artery. Additionally, the chemotherapy agent can cause intra-arterial retinal precipitates. Therefore, it is expected that the dilation of the retinal artery may reduce the cardio-respiratory side effects and intra-arterial retinal precipitates.
The hypothesis of this study is that the intravenously infused nitroglycerin will increase the compliance of the ophthalmic and retinal artery and decrease vagal stimulation and cardio-respiratory side effects during catheter manipulation and chemotherapy agent infusion. This is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of intravenously infused nitroglycerin and saline on the incidence of the cardio-respiratory side effect in pediatric retinoblastoma patients undergoing intra-arterial chemotherapy. Prior to the procedure, each patient will be randomized into either the control-first arm, saline, or study-first arm, nitroglycerin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- — 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Retinoblastoma patients who need intra-arterial chemotherapy under general anesthesia
- •Residual intra-arterial chemotherapy ≥ 2 times (cross-over design)
排除标准
- •Respiratory disease causing a decrease in lung compliance
- •Unstable vital sign, significant arrhythmia or hypotension, Shock
- •Hypersensitivity or contraindication to nitroglycerin
- •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
Nitroglycerin
Intravenous nitroglycerin (0.5mcg/kg/min) is infused after the induction of general anesthesia and during intra-arterial chemotherapy.
干预措施: Nitroglycerin (Drug)
Normal saline
Normal saline is infused after the induction of general anesthesia and during intra-arterial chemotherapy.
干预措施: Normal saline (Drug)
结局指标
主要结局
The incidence of the cardio-respiratory side effects during ophthalmic artery selection and intra-arterial injection of chemotherapy agents. (percent)
时间窗: During the intra-arterial chemotherapy (up to 4 hour)
Bradycardia (\< 80% of Baseline), Hypotension (\< 80% of Baseline), Decrease in the lung compliance, Abnormal end-tidal CO2 curve, or Desaturation (SpO2 \<95%)
次要结局
- The duration of the cardio-respiratory side effects during ophthalmic artery selection and intra-arterial injection of chemotherapy agents. (percent)(During and after the intra-arterial chemotherapy (up to 48 hour))
- The incidence of using vaso-active drugs (percent)(During and after the intra-arterial chemotherapy (up to 48 hour))
- The concentration of inhaled sevoflurane (vol%)(During the intra-arterial chemotherapy (up to 4 hour))
- The depth of anesthesia(During the intra-arterial chemotherapy (up to 4 hour))
- Duration of anesthesia (min)(During the intra-arterial chemotherapy (up to 4 hour))
- The incidence of the side effect of nitroglycerin infusion (percent)(During the intra-arterial chemotherapy (up to 4 hour))
- Total procedure time (min)(During the intra-arterial chemotherapy (up to 4 hour))
- The procedural satisfaction score of radiologist (1-3)(During the intra-arterial chemotherapy (up to 4 hour))
- Incidence of the newly developed focal ischemia or infarct in retina photography(yes or no)(After the intra-arterial chemotherapy (up to 6 month))
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital