Topical Anesthesia and Intra-arterial Chemotherapy for Retinoblastoma
Nyckelord
Abstrakt
Beskrivning
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.
Datum
| Senast verifierad: | 03/31/2018 |
| Först skickat: | 11/01/2016 |
| Beräknad anmälan inlämnad: | 11/02/2016 |
| Först publicerad: | 11/03/2016 |
| Senaste uppdatering skickad: | 04/17/2018 |
| Senaste uppdatering publicerad: | 04/19/2018 |
| Faktiskt startdatum för studien: | 02/28/2018 |
| Uppskattat primärt slutdatum: | 05/31/2020 |
| Beräknat slutfört datum: | 11/30/2020 |
Tillstånd eller sjukdom
Intervention / behandling
Drug: Treatment session 1a
Drug: Treatment session 1a
Fas
Armgrupper
| Ärm | Intervention / behandling |
|---|---|
| Experimental: Treatment session 1a 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: Treatment session 1a 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. |
Urvalskriterier
| Åldrar berättigade till studier | 8 Weeks Till 8 Weeks |
| Kön som är berättigade till studier | All |
| Accepterar friska volontärer | Ja |
| Kriterier | 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 |
Resultat
Primära resultatåtgärder
1. Decrease in systolic Blood Pressure [5 seconds]
2. Drop in end-tidal C02 [5 seconds]
3. Decrease in lung compliance [5 seconds]
4. Decrease in oxygen saturation [5 seconds]
5. Cardiac arrythmia [5 seconds]
Sekundära resultatåtgärder
1. Recovery from Trigeminal-cardiac event [2 minutes]
