Clinical Trial: Cardio-respiratory Events During Ophthalmic Artery Chemotherapy for Retinoblastoma Under a Deep Anesthesia

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Prospective Analysis of Serious Cardio-respiratory Events During Ophthalmic Artery Chemotherapy for Retinoblastoma Under a Deep and Standardized Anesthesia

Brief Summary:

Background: Serious adverse cardio-respiratory events (SCRE) occur during super selective ophthalmic artery chemotherapy for retinoblastoma in children. SCRE mechanism remains unclear but may be attributed to an autonomic nervous reflex induced by catheterization of the ophthalmic artery. The investigators hypothesize that inadequacy between depth of anesthesia and catheter stimulation might be a support cause of these SCRE.

Methods: Children requiring super selective ophthalmic artery chemotherapy for retinoblastoma are prospectively included in this observational study. Endovascular procedures are performed under standardized and deep general anesthesia with sevoflurane, sufentanil and rocuronium. SCRE are strictly pre-defined and included arterial hypotension, bradycardia and bronchospasm. SCRE are recorded and the factors influencing their occurrence are investigated.

Detailed Summary:
Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Current Primary Outcome: Serious adverse cardio-respiratory events during ophthalmic artery chemotherapy for retinoblastoma. [ Time Frame: from the beginning of general anesthesia until the end of injection of chemotherapy in the ophthalmic artery, assessed up to 120 minutes. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Fondation Ophtalmologique Adolphe de Rothschild

Dates:
Date Received: May 1, 2016
Date Started: December 2013
Date Completion:
Last Updated: May 9, 2016
Last Verified: May 2016