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

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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