Nitroglycerin for Intra-arterial Chemotherapy in Pediatric Retinoblastoma.

Seoul National University

Status: Enrolling

Conditions: Retinoblastoma

Treatments: Drug: Normal saline; Drug: Nitroglycerin

Study type: Interventional

Funder types: Other

Identifiers

NCT04564521

2006-108-1134

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: Under 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Retinoblastoma patients who need intra-arterial chemotherapy under general anesthesia
• Residual intra-arterial chemotherapy ≥ 2 times (cross-over design)

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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36 participants in 2 patient groups

Nitroglycerin

Experimental group

Description:

Intravenous nitroglycerin (0.5mcg/kg/min) is infused after the induction of general anesthesia and during intra-arterial chemotherapy.

Treatment:

Drug: Nitroglycerin

Normal saline

Active Comparator group

Description:

Normal saline is infused after the induction of general anesthesia and during intra-arterial chemotherapy.

Treatment:

Drug: Normal saline