Trials / Completed
CompletedNCT02764398
Cardio-respiratory Events During Ophthalmic Artery Chemotherapy for Retinoblastoma Under a Deep Anesthesia
Prospective Analysis of Serious Cardio-respiratory Events During Ophthalmic Artery Chemotherapy for Retinoblastoma Under a Deep and Standardized Anesthesia
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 32 (actual)
- Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild · Network
- Sex
- All
- Age
- 1 Month – 15 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2015-11-01
- First posted
- 2016-05-06
- Last updated
- 2016-05-11
Source: ClinicalTrials.gov record NCT02764398. Inclusion in this directory is not an endorsement.