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
1 other identifier
observational
32
0 countries
N/A
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.
Trial Health
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participants targeted
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 1, 2016
CompletedFirst Posted
Study publicly available on registry
May 6, 2016
CompletedMay 11, 2016
May 1, 2016
1.9 years
May 1, 2016
May 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Serious adverse cardio-respiratory events during ophthalmic artery chemotherapy for retinoblastoma.
from the beginning of general anesthesia until the end of injection of chemotherapy in the ophthalmic artery, assessed up to 120 minutes.
Eligibility Criteria
Children requiring superselective ophthalmic artery chemotherapy for retinoblastoma
You may qualify if:
- superselective ophthalmic artery chemotherapy for retinoblastoma required
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2016
First Posted
May 6, 2016
Study Start
December 1, 2013
Primary Completion
November 1, 2015
Last Updated
May 11, 2016
Record last verified: 2016-05