Nitroglycerin for Intra-arterial Chemotherapy in Pediatric Retinoblastoma.

November 21, 2023 updated by: Jin-Tae Kim, Seoul National University Hospital

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 years (Child)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nitroglycerin
Intravenous nitroglycerin (0.5mcg/kg/min) is infused after the induction of general anesthesia and during intra-arterial chemotherapy.
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.
Other Names:
  • Intravenous nitroglycerin
Active Comparator: Normal saline
Normal saline is infused after the induction of general anesthesia and during intra-arterial chemotherapy.
Drug: Normal saline
Intravenous normal saline is infused after the induction of general anesthesia and during intra-arterial chemotherapy as an active comparator.
Other Names:
  • Intravenous normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of the cardio-respiratory side effects during ophthalmic artery selection and intra-arterial injection of chemotherapy agents. (percent)
Time Frame: During the intra-arterial chemotherapy (up to 4 hour)
Bradycardia (< 80% of Baseline), Hypotension (< 80% of Baseline), Decrease in the lung compliance, Abnormal end-tidal CO2 curve, or Desaturation (SpO2 <95%)
During the intra-arterial chemotherapy (up to 4 hour)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The duration of the cardio-respiratory side effects during ophthalmic artery selection and intra-arterial injection of chemotherapy agents. (percent)
Time Frame: During and after the intra-arterial chemotherapy (up to 48 hour)
Duration between the onset and the recovery from cardio-respiratory side effects.
During and after the intra-arterial chemotherapy (up to 48 hour)
The incidence of using vaso-active drugs (percent)
Time Frame: During and after the intra-arterial chemotherapy (up to 48 hour)
The incidence of using vaso-active drugs (e.g. vasopressor, inotropics)(percent)
During and after the intra-arterial chemotherapy (up to 48 hour)
The incidence of the side effect of nitroglycerin infusion (percent)
Time Frame: During the intra-arterial chemotherapy (up to 4 hour)
Hypotension (< 80% of baseline) after 10 minutes from nitroglycerin infusion, or allergic reaction, etc.
During the intra-arterial chemotherapy (up to 4 hour)
The concentration of inhaled sevoflurane (vol%)
Time Frame: During the intra-arterial chemotherapy (up to 4 hour)
The concentration of inhaled sevoflurane
During the intra-arterial chemotherapy (up to 4 hour)
The depth of anesthesia
Time Frame: During the intra-arterial chemotherapy (up to 4 hour)
The depth of anesthesia (bispectral index or patient sedation index, 0-100, 0 smaller score means deep anesthesia and larger score means awake state.)
During the intra-arterial chemotherapy (up to 4 hour)
Duration of anesthesia (min)
Time Frame: During the intra-arterial chemotherapy (up to 4 hour)
Duration of anesthesia
During the intra-arterial chemotherapy (up to 4 hour)
Total procedure time (min)
Time Frame: During the intra-arterial chemotherapy (up to 4 hour)
From ophthalmic artery selection to the end of intra-arterial injection.
During the intra-arterial chemotherapy (up to 4 hour)
The procedural satisfaction score of radiologist (1-3)
Time Frame: During the intra-arterial chemotherapy (up to 4 hour)
3 grades (1:poor, 2:fair, 3:good)
During the intra-arterial chemotherapy (up to 4 hour)
Incidence of the newly developed focal ischemia or infarct in retina photography(yes or no)
Time Frame: After the intra-arterial chemotherapy (up to 6 month)
Incidence of the newly developed focal ischemia or infarct in retina photography(yes or no) on ophthalmology outpatient clinic after the intra-arterial chemotherapy assessed by pediatric ophthalmologist
After the intra-arterial chemotherapy (up to 6 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2020

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

September 2, 2020

First Submitted That Met QC Criteria

September 21, 2020

First Posted (Actual)

September 25, 2020

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-108-1134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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