Brief Title
Cardio-respiratory Events During Ophthalmic Artery Chemotherapy for Retinoblastoma Under a Deep Anesthesia
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.
Study Type
Observational
Primary Outcome
Serious adverse cardio-respiratory events during ophthalmic artery chemotherapy for retinoblastoma.
Condition
Retinoblastoma
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
32
Start Date
December 2013
Primary Completion Date
November 2015
Eligibility Criteria
Inclusion Criteria: - superselective ophthalmic artery chemotherapy for retinoblastoma required Exclusion Criteria: - no
Gender
All
Ages
1 Month - 15 Years
Accepts Healthy Volunteers
No
Contacts
, ,
Administrative Informations
NCT ID
NCT02764398
Organization ID
NI_2016_1
Responsible Party
Sponsor
Study Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Study Sponsor
, ,
Verification Date
May 2016