NCT04455776

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 99 (actual)
• Sponsor: Brugmann University Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• Multiparametric Magnetic Resonance Imaging
• Propofol Adverse Reaction
• Sedation Complication
• Anesthesia; Adverse Effect

Interventions

Type	Name	Description
DRUG	Propofol	Sedation by propofol

Timeline

• Start date: 2020-07-03
• Primary completion: 2020-07-30
• Completion: 2020-07-30
• First posted: 2020-07-02
• Last updated: 2020-08-26

Locations

1 site across 1 country: Belgium