NCT04564521

Nitroglycerin for Intra-arterial Chemotherapy in Pediatric Retinoblastoma.

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Retinoblastoma

Interventions

Type	Name	Description
DRUG	Nitroglycerin	Intravenous nitroglycerin (0.5mcg/kg/min) is infused after the induction of general anesthesia and during intra-arterial chemotherapy to reduce the cardio-respiratory side effects.
DRUG	Normal saline	Intravenous normal saline is infused after the induction of general anesthesia and during intra-arterial chemotherapy as an active comparator.

Timeline

• Start date: 2020-09-28
• Primary completion: 2024-06-30
• Completion: 2024-12-30
• First posted: 2020-09-25
• Last updated: 2023-11-22

Locations

1 site across 1 country: South Korea