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Topical Anesthesia to Decrease the Trigeminal-Cardiac Reflex During Intra-arterial Injection of Chemotherapy for Retinoblastoma in Children. (TOPIAC)
The objective of this study is to use local topical anesthesia to numb the sensory input, captured by branches of the Trigeminal nerve found on the skin in and around the eye, to decrease a hemodynamic reflex seen during placement of a catheter for intra-arterial chemotherapy (IAC) for eye tumors in children. This Trigeminal-cardiac reflex brings about hemodynamic instability during general anesthesia. Normally, one could block this sensorial input with ophthalmic peribulbar placement of local anesthetics, but these eyes have malignant growth and invasive procedures may cause more harm. The investigators are aiming to numb the sensory branches of the trigeminal nerve non-invasively and observe for any decrease in these events.
Details
| Lead sponsor | University of Miami |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | WITHDRAWN |
| Start date | 2018-03 |
| Completion | 2020-12 |
Conditions
- Hemodynamic Instability
Interventions
- Tetracaine 0.5%
- Lidocaine hydrochloride ophthalmic gel 3.5%
Primary outcomes
- Decrease in systolic Blood Pressure — 5 seconds
Interventionalist will communicate to the investigator of the catheter placement and our outcome measure will be recorded soon after. - Drop in end-tidal C02 — 5 seconds
Interventionalist will communicate to the investigator of the catheter placement and our outcome measure will be recorded soon after. - Decrease in lung compliance — 5 seconds
Interventionalist will communicate to the investigator of the catheter placement and our outcome measure will be recorded soon after. - Decrease in oxygen saturation — 5 seconds
Interventionalist will communicate to the investigator of the catheter placement and our outcome measure will be recorded soon after. - Cardiac arrythmia — 5 seconds
Interventionalist will communicate to the investigator of the catheter placement and our outcome measure will be recorded soon after.