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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02764398
Other study ID # NI_2016_1
Secondary ID
Status Completed
Phase N/A
First received May 1, 2016
Last updated May 9, 2016
Start date December 2013

Study information

Verified date May 2016
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority France: Ethics Committee
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 15 Years
Eligibility Inclusion Criteria:

- superselective ophthalmic artery chemotherapy for retinoblastoma required

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Outcome

Type Measure Description Time frame Safety issue
Primary 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. No
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