Nitroglycerin for Intra-arterial Chemotherapy in Pediatric Retinoblastoma.
NCT ID: NCT04564521
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36 participants
INTERVENTIONAL
2020-09-28
2024-12-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
At the first intra-arterial chemotherapy after enrollment, saline or nitroglycerin is used according to the group allocation.
At the second intra-arterial chemotherapy after enrollment, nitroglycerin is used for the saline-first arm, and saline is used for the nitroglycerin-first arm.
TREATMENT
DOUBLE
Study Groups
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Nitroglycerin
Intravenous nitroglycerin (0.5mcg/kg/min) is infused after the induction of general anesthesia and during intra-arterial chemotherapy.
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.
Normal saline
Normal saline is infused after the induction of general anesthesia and during intra-arterial chemotherapy.
Normal saline
Intravenous normal saline is infused after the induction of general anesthesia and during intra-arterial chemotherapy as an active comparator.
Interventions
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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.
Normal saline
Intravenous normal saline is infused after the induction of general anesthesia and during intra-arterial chemotherapy as an active comparator.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Residual intra-arterial chemotherapy ≥ 2 times (cross-over design)
Exclusion Criteria
* 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)
7 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Jin-Tae Kim
Professor
Locations
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Jin-Tae Kim
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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FRAYSER R, HICKAM JB. EFFECT OF VASODILATOR DRUGS ON THE RETINAL BLOOD FLOW IN MAN. Arch Ophthalmol. 1965 May;73:640-2. doi: 10.1001/archopht.1965.00970030642008. No abstract available.
Yaster M, Simmons RS, Tolo VT, Pepple JM, Wetzel RC, Rogers MC. A comparison of nitroglycerin and nitroprusside for inducing hypotension in children: a double-blind study. Anesthesiology. 1986 Aug;65(2):175-9. doi: 10.1097/00000542-198608000-00008.
Dorner GT, Garhofer G, Kiss B, Polska E, Polak K, Riva CE, Schmetterer L. Nitric oxide regulates retinal vascular tone in humans. Am J Physiol Heart Circ Physiol. 2003 Aug;285(2):H631-6. doi: 10.1152/ajpheart.00111.2003. Epub 2003 May 15.
Munier FL, Beck-Popovic M, Balmer A, Gaillard MC, Bovey E, Binaghi S. Occurrence of sectoral choroidal occlusive vasculopathy and retinal arteriolar embolization after superselective ophthalmic artery chemotherapy for advanced intraocular retinoblastoma. Retina. 2011 Mar;31(3):566-73. doi: 10.1097/IAE.0b013e318203c101.
Shields CL, Bianciotto CG, Jabbour P, Ramasubramanian A, Lally SE, Griffin GC, Rosenwasser R, Shields JA. Intra-arterial chemotherapy for retinoblastoma: report No. 1, control of retinal tumors, subretinal seeds, and vitreous seeds. Arch Ophthalmol. 2011 Nov;129(11):1399-406. doi: 10.1001/archophthalmol.2011.150. Epub 2011 Jun 13.
Shields CL, Bianciotto CG, Jabbour P, Griffin GC, Ramasubramanian A, Rosenwasser R, Shields JA. Intra-arterial chemotherapy for retinoblastoma: report No. 2, treatment complications. Arch Ophthalmol. 2011 Nov;129(11):1407-15. doi: 10.1001/archophthalmol.2011.151. Epub 2011 Jun 13.
Fallaha N, Dubois J, Carret AS, Callejo SA, Hamel P, Superstein R. Real-time ophthalmoscopic findings of intraophthalmic artery chemotherapy in retinoblastoma. Arch Ophthalmol. 2012 Aug;130(8):1075-7. doi: 10.1001/archophthalmol.2012.180. No abstract available.
Cugati S, Varma DD, Chen CS, Lee AW. Treatment options for central retinal artery occlusion. Curr Treat Options Neurol. 2013 Feb;15(1):63-77. doi: 10.1007/s11940-012-0202-9.
Phillips TJ, McGuirk SP, Chahal HK, Kingston J, Robertson F, Brew S, Roebuck D, Hungerford JL, Herod J. Autonomic cardio-respiratory reflex reactions and superselective ophthalmic arterial chemotherapy for retinoblastoma. Paediatr Anaesth. 2013 Oct;23(10):940-5. doi: 10.1111/pan.12162. Epub 2013 May 13.
Kato MA, Green N, O'Connell K, Till SD, Kramer DJ, Al-Khelaifi M, Han JH, Pryor KO, Gobin YP, Proekt A. A retrospective analysis of severe intraoperative respiratory compliance changes during ophthalmic arterial chemosurgery for retinoblastoma. Paediatr Anaesth. 2015 Jun;25(6):595-602. doi: 10.1111/pan.12603. Epub 2015 Jan 7.
Scharoun JH, Han JH, Gobin YP. Anesthesia for Ophthalmic Artery Chemosurgery. Anesthesiology. 2017 Jan;126(1):165-172. doi: 10.1097/ALN.0000000000001381. No abstract available.
Other Identifiers
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2006-108-1134
Identifier Type: -
Identifier Source: org_study_id