Brief Title
Nitroglycerin for Intra-arterial Chemotherapy in Pediatric Retinoblastoma.
Official Title
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
Brief 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.
Study Type
Interventional
Primary Outcome
The incidence of the cardio-respiratory side effects during ophthalmic artery selection and intra-arterial injection of chemotherapy agents. (percent)
Secondary Outcome
The duration of the cardio-respiratory side effects during ophthalmic artery selection and intra-arterial injection of chemotherapy agents. (percent)
Condition
Retinoblastoma
Intervention
Nitroglycerin
Study Arms / Comparison Groups
Nitroglycerin
Description: Intravenous nitroglycerin (0.5mcg/kg/min) is infused after the induction of general anesthesia and during intra-arterial chemotherapy.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
36
Start Date
September 28, 2020
Completion Date
June 30, 2022
Primary Completion Date
June 30, 2022
Eligibility Criteria
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)
Gender
All
Ages
N/A - 7 Years
Accepts Healthy Volunteers
No
Contacts
, 82-2-2072-3664, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT04564521
Organization ID
2006-108-1134
Responsible Party
Principal Investigator
Study Sponsor
Seoul National University Hospital
Study Sponsor
, ,
Verification Date
October 2020