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

Sedation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04455776
• Other study ID #: CHUB_PEDIRM
• Status: Completed
• Start date: July 3, 2020
• Est. completion date: July 30, 2020

Study information

• Verified date: August 2020
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2020
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Propofol
Sedation by propofol

Locations

Country	Name	City	State
Belgium	Hôpital Universitaire des Enfants Reine Fabiola	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoxemia	Arterial desaturation defined as number of episodes with an SpO2=94%	90 minutes
Primary	Hypercapnia	Hypercapnia, defined as number of episodes with an ETCO2 > 45 mm HG	90 minutes
Primary	Movements	Number of patient movements interfering with the MRI exam	90 minutes