Topical Anesthesia and Intra-arterial Chemotherapy for Retinoblastoma

Early Phase 1

Withdrawn

• Conditions: Hemodynamic Instability
• Interventions: Drug: Tetracaine 0.5%; Drug: Lidocaine hydrochloride ophthalmic gel 3.5%

• Registration Number: NCT02955524
• Lead Sponsor: University of Miami

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 Description

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 surface of the eye. This gel is placed on the surface of the eye and skin around the eye to numb V1 and V2 fibers of the trigeminal nerve. The study will observe if there is any decrease in the intensity of the reflex or incidence of the reflex during placement of the micro-catheter.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2016-11-02
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-04
• Study Start: 2018-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-18
• Last Update Posted: 2018-04-20
• Primary Completion: 2020-06
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Children with Retinoblastoma diagnosis scheduled for Intra-arterial chemotherapy under general anesthesia

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Exclusion Criteria

• any candidate with history of allergy to anesthetics or preservatives used in local anesthetics any candidate that has a history of allergic dermatitis any candidate that has an open wound in and around the eye to be treated

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment session 1a	Tetracaine 0.5%	Topical ophthalmic anesthesia to participants (#) on each session (letter) of intra-arterial chemotherapy. where #1 is the participant identifier and letter-a is the start session with study protocol (most candidates will receive more than 4 sessions in a 6 month period)
Treatment session 1a	Lidocaine hydrochloride ophthalmic gel 3.5%	Topical ophthalmic anesthesia to participants (#) on each session (letter) of intra-arterial chemotherapy. where #1 is the participant identifier and letter-a is the start session with study protocol (most candidates will receive more than 4 sessions in a 6 month period)

Primary Outcome Measures

Name	Time	Method
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.
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 oxygen saturation	5 seconds	Interventionalist will communicate to the investigator of the catheter placement and our outcome measure will be recorded soon after.
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.
Cardiac arrythmia	5 seconds	Interventionalist will communicate to the investigator of the catheter placement and our outcome measure will be recorded soon after.

Secondary Outcome Measures

Name	Time	Method
Recovery from Trigeminal-cardiac event	2 minutes	Investigator will communicate when the event is over or rescue drugs given.