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

Completed

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

• Registration Number: NCT04455776
• Lead Sponsor: Brugmann University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2020-06-25
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-02
• Study Start: 2020-07-03
• Primary Completion: 2020-07-30
• Study Completion: 2020-07-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-25
• Last Update Posted: 2020-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hypoxemia	90 minutes	Arterial desaturation defined as number of episodes with an SpO2≤94%
Hypercapnia	90 minutes	Hypercapnia, defined as number of episodes with an ETCO2 \> 45 mm HG
Movements	90 minutes	Number of patient movements interfering with the MRI exam

Trial Locations

Locations (1)

Hôpital Universitaire des Enfants Reine Fabiola; 🇧🇪 Brussels, Belgium