MedTrace Logo

Topical Anesthesia and Intra-arterial Chemotherapy for Retinoblastoma

NCT02955524 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2018-04-20

No results posted yet for this study

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.

Conditions

  • Hemodynamic Instability

Interventions

DRUG

Tetracaine 0.5%

One drop of 0.5% Proparacaine to nasolacrimal Duct to numb the ethmoidal nerve in the nasal passage on the side of the eye to be treated.

DRUG

Lidocaine hydrochloride ophthalmic gel 3.5%

1ml of lidocaine gel is placed over the conjunctivae of the eye to be treated after the patient is under general anesthesia and before the procedure

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Jacqueline Tutiven, MD · Director Pediatric Anesthesia Fellowship/Assistant Professor

  • Norman Halliday, MD · Chief, Pediatric Anesthesiology

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-31
Primary Completion
2020-06-30
Completion
2020-12-31
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02955524 on ClinicalTrials.gov