Topical Anesthesia and Intra-arterial Chemotherapy for Retinoblastoma

Hemodynamic Instability Clinical Trial

— TOPIAC  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02955524
• Other study ID #: 20161001
• Status: Withdrawn
• Phase: Early Phase 1
• First received: November 2, 2016
• Last updated: April 18, 2018
• Start date: March 2018
• Est. completion date: December 2020

Study information

• Verified date: April 2018
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Weeks and older

Eligibility

Inclusion Criteria:

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

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

Related Conditions & MeSH terms

• Hemodynamic Instability
• Retinoblastoma

Intervention

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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

References & Publications (2)

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.PEDS127 — View Citation

Scharoun JH, Han JH, Gobin YP. Anesthesia for Ophthalmic Artery Chemosurgery. Anesthesiology. 2017 Jan;126(1):165-172. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Cardiac arrythmia	Interventionalist will communicate to the investigator of the catheter placement and our outcome measure will be recorded soon after.	5 seconds
Secondary	Recovery from Trigeminal-cardiac event	Investigator will communicate when the event is over or rescue drugs given.	2 minutes