Retinoblastoma
Conditions
Keywords
Intra-arterial chemotherapy, Cardio-respiratory side effects, Nitroglycerin
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.
Interventions
DRUGNitroglycerin
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.
DRUGNormal saline
Intravenous normal saline is infused after the induction of general anesthesia and during intra-arterial chemotherapy as an active comparator.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Prior to the procedure, each patient will be randomized into either the saline-first arm or nitroglycerin-first arm. 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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 7 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of the cardio-respiratory side effects during ophthalmic artery selection and intra-arterial injection of chemotherapy agents. (percent) | 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%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of using vaso-active drugs (percent) | During and after the intra-arterial chemotherapy (up to 48 hour) | The incidence of using vaso-active drugs (e.g. vasopressor, inotropics)(percent) |
| The incidence of the side effect of nitroglycerin infusion (percent) | During the intra-arterial chemotherapy (up to 4 hour) | Hypotension (\< 80% of baseline) after 10 minutes from nitroglycerin infusion, or allergic reaction, etc. |
| The concentration of inhaled sevoflurane (vol%) | During the intra-arterial chemotherapy (up to 4 hour) | The concentration of inhaled sevoflurane |
| The depth of anesthesia | 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.) |
| The duration of the cardio-respiratory side effects during ophthalmic artery selection and intra-arterial injection of chemotherapy agents. (percent) | During and after the intra-arterial chemotherapy (up to 48 hour) | Duration between the onset and the recovery from cardio-respiratory side effects. |
| Total procedure time (min) | During the intra-arterial chemotherapy (up to 4 hour) | From ophthalmic artery selection to the end of intra-arterial injection. |
| The procedural satisfaction score of radiologist (1-3) | During the intra-arterial chemotherapy (up to 4 hour) | 3 grades (1:poor, 2:fair, 3:good) |
| Incidence of the newly developed focal ischemia or infarct in retina photography(yes or no) | 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 |
| Duration of anesthesia (min) | During the intra-arterial chemotherapy (up to 4 hour) | Duration of anesthesia |
Countries
South Korea
Contacts
Primary ContactYoung-Eun Jang, MD
Backup ContactJin-Tae Kim, MD, PhD
Outcome results
None listed