Nitroglycerin for Intra-arterial Chemotherapy in Pediatric Retinoblastoma.
- Registration Number
- NCT04564521
- Lead Sponsor
- Seoul National University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
- Retinoblastoma patients who need intra-arterial chemotherapy under general anesthesia
- Residual intra-arterial chemotherapy ≥ 2 times (cross-over design)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Nitroglycerin Nitroglycerin Intravenous nitroglycerin (0.5mcg/kg/min) is infused after the induction of general anesthesia and during intra-arterial chemotherapy. Normal saline Normal saline Normal saline is infused after the induction of general anesthesia and during intra-arterial chemotherapy.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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 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.)
Duration of anesthesia (min) During the intra-arterial chemotherapy (up to 4 hour) Duration of anesthesia
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.
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
Trial Locations
- Locations (1)
Jin-Tae Kim
🇰🇷Seoul, Korea, Republic of