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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
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.
Intravenous normal saline is infused after the induction of general anesthesia and during intra-arterial chemotherapy as an active comparator.
Jin-Tae Kim
Seoul, South Korea
RECRUITINGThe incidence of the cardio-respiratory side effects during ophthalmic artery selection and intra-arterial injection of chemotherapy agents. (percent)
Bradycardia (\< 80% of Baseline), Hypotension (\< 80% of Baseline), Decrease in the lung compliance, Abnormal end-tidal CO2 curve, or Desaturation (SpO2 \<95%)
Time frame: During the intra-arterial chemotherapy (up to 4 hour)
The duration of the cardio-respiratory side effects during ophthalmic artery selection and intra-arterial injection of chemotherapy agents. (percent)
Duration between the onset and the recovery from cardio-respiratory side effects.
Time frame: During and after the intra-arterial chemotherapy (up to 48 hour)
The incidence of using vaso-active drugs (percent)
The incidence of using vaso-active drugs (e.g. vasopressor, inotropics)(percent)
Time frame: During and after the intra-arterial chemotherapy (up to 48 hour)
The incidence of the side effect of nitroglycerin infusion (percent)
Hypotension (\< 80% of baseline) after 10 minutes from nitroglycerin infusion, or allergic reaction, etc.
Time frame: During the intra-arterial chemotherapy (up to 4 hour)
The concentration of inhaled sevoflurane (vol%)
The concentration of inhaled sevoflurane
Time frame: During the intra-arterial chemotherapy (up to 4 hour)
The depth of anesthesia
The depth of anesthesia (bispectral index or patient sedation index, 0-100, 0 smaller score means deep anesthesia and larger score means awake state.)
Time frame: During the intra-arterial chemotherapy (up to 4 hour)
Duration of anesthesia (min)
Duration of anesthesia
Time frame: During the intra-arterial chemotherapy (up to 4 hour)
Total procedure time (min)
From ophthalmic artery selection to the end of intra-arterial injection.
Time frame: During the intra-arterial chemotherapy (up to 4 hour)
The procedural satisfaction score of radiologist (1-3)
3 grades (1:poor, 2:fair, 3:good)
Time frame: During the intra-arterial chemotherapy (up to 4 hour)
Incidence of the newly developed focal ischemia or infarct in retina photography(yes or no)
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
Time frame: After the intra-arterial chemotherapy (up to 6 month)
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