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临床试验/NCT04455776
NCT04455776已完成不适用

Incidence of Adverse Events During Propofol Sedation for Magnetic Resonance Imaging in Pediatric Patients

Brugmann University Hospital1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2020年7月3日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
99
试验地点
1
主要终点
Hypoxemia

研究概览

简要总结

Propofol is often used for sedation in children undergoing magnetic resonance imaging. The investigators will perform a chart review of 4 month of activity (about 100 cases) and review the incidence and severity of adverse events of this sedation technique.

详细描述

Magnetic resonance imaging in children, especially under 6 years of age, is often performed under sedation. Propofol is a common drug used in this settings. In our institution, sedation is most often done by a propofol bolus of 2-5 mg/kg in order to reach a deep level of sedation as defined by Coté et al. If judged necessary by the attending anaesthesiologist, a additional propofol bolus of 0.5-1 mg/kg may be given. For longer lasting exams, the attending anaesthesiologist can chose to use a continuous infusion of propofol. The investigators will review the charts of 4 month of magnetic resonance imaging, which will give us a cohort of about 100 patients. Baseline characteristics, detailed sedation technique used will be recorded. Adverse events defined as:

  • Oxygen desaturation measured by transcutaneous oximetry SpO2≤94%
  • hypercapnia measure by end-tidal CO2 >45 mm Hg
  • movement of the patient

Assuming a non-normal distribution (tested by a Kolmogorov-Smirnov test), variables will be reported as median and interquartile range. Statistical tests will be done by non-parametric tests, Mann Whitney U. Non continuous variables will be analyzed by a Chi-square test.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients scheduled for MRI under sedation by an anaesthesiologist
  • Age < 16 years

排除标准

  • Age > 16 years
  • Sedation performed by a non-anesthesiologist

结局指标

主要结局

Hypoxemia

时间窗: 90 minutes

Arterial desaturation defined as number of episodes with an SpO2≤94%

Hypercapnia

时间窗: 90 minutes

Hypercapnia, defined as number of episodes with an ETCO2 \> 45 mm HG

Movements

时间窗: 90 minutes

Number of patient movements interfering with the MRI exam

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Denis SCHMARTZ

Head of Anesthesiology department

Brugmann University Hospital

研究点 (1)

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