Topical Anesthesia and Intra-arterial Chemotherapy for Retinoblastoma

NCT02955524 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: 20161001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemodynamic Instability

Outcome Measures

Primary Outcomes (5)

• Decrease in systolic Blood Pressure

  Interventionalist will communicate to the investigator of the catheter placement and our outcome measure will be recorded soon after.

  5 seconds

• Drop in end-tidal C02

  Interventionalist will communicate to the investigator of the catheter placement and our outcome measure will be recorded soon after.

  5 seconds

• Decrease in lung compliance

  Interventionalist will communicate to the investigator of the catheter placement and our outcome measure will be recorded soon after.

  5 seconds

• Decrease in oxygen saturation

  Interventionalist will communicate to the investigator of the catheter placement and our outcome measure will be recorded soon after.

  5 seconds

• Cardiac arrythmia

  Interventionalist will communicate to the investigator of the catheter placement and our outcome measure will be recorded soon after.

  5 seconds

Secondary Outcomes (1)

• Recovery from Trigeminal-cardiac event

  2 minutes

Study Arms (1)

Treatment session 1a

EXPERIMENTAL

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)

Drug: Tetracaine 0.5%; Drug: Lidocaine hydrochloride ophthalmic gel 3.5%

Interventions

Tetracaine 0.5% DRUG

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.

Treatment session 1a

Lidocaine hydrochloride ophthalmic gel 3.5% DRUG

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

Also known as: Akten

Treatment session 1a

Eligibility Criteria

• Age: 8 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Related Publications (2)

• Scharoun JH, Han JH, Gobin YP. Anesthesia for Ophthalmic Artery Chemosurgery. Anesthesiology. 2017 Jan;126(1):165-172. doi: 10.1097/ALN.0000000000001381. No abstract available.

  PMID: 27748655 RESULT

• Jabbour P, Chalouhi N, Tjoumakaris S, Gonzalez LF, Dumont AS, Chitale R, Rosenwasser R, Bianciotto CG, Shields C. Pearls and pitfalls of intraarterial chemotherapy for retinoblastoma. J Neurosurg Pediatr. 2012 Sep;10(3):175-81. doi: 10.3171/2012.5.PEDS1277. Epub 2012 Jul 13.

  PMID: 22793160 RESULT

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jacqueline Tutiven, MD

  Director Pediatric Anesthesia Fellowship/Assistant Professor

  PRINCIPAL INVESTIGATOR

• Norman Halliday, MD

  Chief, Pediatric Anesthesiology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Anesthesiology/Pediatric Anesthesia Dir.

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 4, 2016
• Study Start: March 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 20, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share