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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- The incidence of the cardio-respiratory side effects during ophthalmic artery selection and intra-arterial injection of chemotherapy agents. (percent)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- — to 7 Years (Child)
- Sex
- All
- Accepts 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)
Arms & Interventions
Nitroglycerin
Intravenous nitroglycerin (0.5mcg/kg/min) is infused after the induction of general anesthesia and during intra-arterial chemotherapy.
Intervention: Nitroglycerin (Drug)
Normal saline
Normal saline is infused after the induction of general anesthesia and during intra-arterial chemotherapy.
Intervention: Normal saline (Drug)
Outcomes
Primary Outcomes
The incidence of the cardio-respiratory side effects during ophthalmic artery selection and intra-arterial injection of chemotherapy agents. (percent)
Time Frame: 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 Outcomes
- 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))
- The incidence of using vaso-active drugs (percent)(During and after the intra-arterial chemotherapy (up to 48 hour))
- The concentration of inhaled sevoflurane (vol%)(During the intra-arterial chemotherapy (up to 4 hour))
- The depth of anesthesia(During the intra-arterial chemotherapy (up to 4 hour))
- Duration of anesthesia (min)(During the intra-arterial chemotherapy (up to 4 hour))
- The incidence of the side effect of nitroglycerin infusion (percent)(During the intra-arterial chemotherapy (up to 4 hour))
- Total procedure time (min)(During the intra-arterial chemotherapy (up to 4 hour))
- The procedural satisfaction score of radiologist (1-3)(During the intra-arterial chemotherapy (up to 4 hour))
- Incidence of the newly developed focal ischemia or infarct in retina photography(yes or no)(After the intra-arterial chemotherapy (up to 6 month))
Investigators
Jin-Tae Kim
Professor
Seoul National University Hospital