Nitroglycerin for Intra-arterial Chemotherapy in Pediatric Retinoblastoma.
Status:
Recruiting
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
Summary
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.