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OpenTrials
Completed

NCT Number: NCT04455776

Safety Evaluation of Propofol Sedation for Magnetic Resonance Imaging in Pediatric Patients

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.

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Key information

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Universitaire des Enfants Reine Fabiola

Brussels, 1020, Belgium

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Propofol

Drug

Sedation by propofol

Primary outcomes

  1. Hypoxemia

    Time frame: 90 minutes

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

  2. Hypercapnia

    Time frame: 90 minutes

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

  3. Movements

    Time frame: 90 minutes

    Number of patient movements interfering with the MRI exam

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 2, 2020
Registry last updated
Aug 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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