跳至主要内容
临床试验/NCT02764398
NCT02764398已完成不适用

Prospective Analysis of Serious Cardio-respiratory Events During Ophthalmic Artery Chemotherapy for Retinoblastoma Under a Deep and Standardized Anesthesia

Fondation Ophtalmologique Adolphe de Rothschild0 个研究点目标入组 32 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
主要终点
Serious adverse cardio-respiratory events during ophthalmic artery chemotherapy for retinoblastoma.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
1 Month 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • superselective ophthalmic artery chemotherapy for retinoblastoma required

排除标准

  • 未提供

结局指标

主要结局

Serious adverse cardio-respiratory events during ophthalmic artery chemotherapy for retinoblastoma.

时间窗: from the beginning of general anesthesia until the end of injection of chemotherapy in the ophthalmic artery, assessed up to 120 minutes.

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

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