Nitroglycerin for Intra-arterial Chemotherapy in Pediatric Retinoblastoma.

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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