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: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 7
Healthy Volunteers: f
View:

• Retinoblastoma patients who need intra-arterial chemotherapy under general anesthesia

• Residual intra-arterial chemotherapy ≥ 2 times (cross-over design)

Locations
Other Locations
Republic of Korea
Jin-Tae Kim
RECRUITING
Seoul
Contact Information
Primary
Young-Eun Jang, MD
na0ag2@hotmail.com
82-2-2072-3664
Backup
Jin-Tae Kim, MD, PhD
jintae73@gmail.com
82-2-2072-3664
Time Frame
Start Date: 2020-09-28
Estimated Completion Date: 2024-12-30
Participants
Target number of participants: 36
Treatments
Experimental: Nitroglycerin
Intravenous nitroglycerin (0.5mcg/kg/min) is infused after the induction of general anesthesia and during intra-arterial chemotherapy.
Active_comparator: Normal saline
Normal saline is infused after the induction of general anesthesia and during intra-arterial chemotherapy.
Sponsors
Leads: Seoul National University Hospital

This content was sourced from clinicaltrials.gov