Retinoblastoma Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | December 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 7 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Jin-Tae Kim | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The 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%) | During the intra-arterial chemotherapy (up to 4 hour) | |
Secondary | 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. | During and after the intra-arterial chemotherapy (up to 48 hour) | |
Secondary | The incidence of using vaso-active drugs (percent) | The incidence of using vaso-active drugs (e.g. vasopressor, inotropics)(percent) | During and after the intra-arterial chemotherapy (up to 48 hour) | |
Secondary | The incidence of the side effect of nitroglycerin infusion (percent) | Hypotension (< 80% of baseline) after 10 minutes from nitroglycerin infusion, or allergic reaction, etc. | During the intra-arterial chemotherapy (up to 4 hour) | |
Secondary | The concentration of inhaled sevoflurane (vol%) | The concentration of inhaled sevoflurane | During the intra-arterial chemotherapy (up to 4 hour) | |
Secondary | 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.) | During the intra-arterial chemotherapy (up to 4 hour) | |
Secondary | Duration of anesthesia (min) | Duration of anesthesia | During the intra-arterial chemotherapy (up to 4 hour) | |
Secondary | Total procedure time (min) | From ophthalmic artery selection to the end of intra-arterial injection. | During the intra-arterial chemotherapy (up to 4 hour) | |
Secondary | The procedural satisfaction score of radiologist (1-3) | 3 grades (1:poor, 2:fair, 3:good) | During the intra-arterial chemotherapy (up to 4 hour) | |
Secondary | 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 | After the intra-arterial chemotherapy (up to 6 month) |
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