Clinical Trial: Topical Anesthesia and Intra-arterial Chemotherapy for Retinoblastoma

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Topical Anesthesia to Decrease the Trigeminal-Cardiac Reflex During Intra-arterial Injection of Chemotherapy for Retinoblastoma in Children.

Brief Summary:

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.

Detailed Summary:

Retinoblastoma is a rare tumor of the eye and accounts for 6% of malignancies in children less than 5 years of age. Pediatric anesthesiologists have observed a series of hemodynamic instability following the insertion of a catheter into the cavernous segment of the internal carotid artery or during manipulation of a micro-catheter into the ophthalmic artery for intra-arterial chemotherapy (IAC) of retinoblastoma cases by neuroradiologists. This reaction has been recently published in case reports and observational studies as the treatment of these tumors have moved into the interventional imaging suites. This reaction closely resembles the "diving reflex" seen when a person is submerged in cold water; known as the trigeminal-cardiac reflex. It manifests as a sudden hemodynamic disturbance in arterial blood pressure, heart rate, arrhythmia and changes in pulmonary compliance.Rescue from a trigeminal-cardiac reflex entails increasing intravascular volume, administrating mild to resuscitative doses of epinephrine and ventilatory support.

Catheter manipulation around the ophthalmic artery can stimulate the afferent pathway of the trigeminal nerve, branches V1 and V2, originating around the eye to be treated.The ethmoidal nerve, from the nasal passage on the same side, is also stimulated. This in turn triggers a response by the vagus nerve with hemodynamic instability.

Method: Participants are placed under general endotracheal anesthesia for this scheduled procedure. One drop of ocular antiseptic (betadine 5%) will be placed in the eye to be treated followed by a drop of topical FDA approved local anesthetic, Tetracaine 0.5%, to the nasolacrimal duct ( inner corner of the eye) on the eye to be treated. This will numb the ethmoidal nerve in the nasal passage. This is followed by 1 ml of 3.5% Lidocaine gel to the surfac
Sponsor: University of Miami

Current Primary Outcome:

• Decrease in systolic Blood Pressure [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 5 seconds ]
  Interventionalist will communicate to the investigator of the catheter placement and our outcome measure will be recorded soon after.
• Cardiac arrythmia [ Time Frame: 5 seconds ]
  Interventionalist will communicate to the investigator of the catheter placement and our outcome measure will be recorded soon after.

Original Primary Outcome:

• Decrease in systolic Blood Pressure [ Time Frame: 5 seconds ]
  Interventionalist will communicate to the anesthesia team provider of the catheter placement and our outcome measure will be recorded soon after.
• Drop in end-tidal C02 [ Time Frame: 5 seconds ]
  Interventionalist will communicate to the anesthesia team provider of the catheter placement and our outcome measure will be recorded soon after.
• Decrease in lung compliance [ Time Frame: 5 seconds ]
  Interventionalist will communicate to the anesthesia team provider of the catheter placement and our outcome measure will be recorded soon after.
• Decrease in oxygen saturation [ Time Frame: 5 seconds ]
  Interventionalist will communicate to the anesthesia team provider of the catheter placement and our outcome measure will be recorded soon after.
• Cardiac arrythmia [ Time Frame: 5 seconds ]
  Interventionalist will communicate to the anesthesia team provider of the catheter placement and our outcome measure will be recorded soon after.

Current Secondary Outcome: Recovery from Trigeminal-cardiac event [ Time Frame: 2 minutes ]

Original Secondary Outcome: Recovery from Trigeminal-cardiac event [ Time Frame: 2 minutes ]

Information By: University of Miami

Dates:
Date Received: November 2, 2016
Date Started: December 2016
Date Completion: December 2017
Last Updated: November 3, 2016
Last Verified: November 2016