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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04455776
Enrollment
99
Registered
2020-07-02
Start date
2020-07-03
Completion date
2020-07-30
Last updated
2020-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGPropofol

Sedation by propofol

Sponsors

Brugmann University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 16 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Hypoxemia90 minutesArterial desaturation defined as number of episodes with an SpO2≤94%
Hypercapnia90 minutesHypercapnia, defined as number of episodes with an ETCO2 \> 45 mm HG
Movements90 minutesNumber of patient movements interfering with the MRI exam

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026