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

• Sponsor: Brugmann University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04455776
• Collaborator: (none)
• Enrollment: 99
• Location: 1
• Actual Duration (Days): 27
• Patients Per Site Per Month: 111.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiparametric Magnetic Resonance Imaging; Propofol Adverse Reaction; Sedation Complication; Anesthesia; Adverse Effect	Drug: Propofol

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 Design

• Study Type: Observational
• Actual Enrollment: 99 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Incidence of Adverse Events During Propofol Sedation for Magnetic Resonance Imaging in Pediatric Patients
• Actual Study Start Date: Jul 3, 2020
• Actual Primary Completion Date: Jul 30, 2020
• Actual Study Completion Date: Jul 30, 2020

Outcome Measures

Primary Outcome Measures

1. Hypoxemia [90 minutes]

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

2. Hypercapnia [90 minutes]

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

3. Movements [90 minutes]

   Number of patient movements interfering with the MRI exam

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 16 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Universitaire des Enfants Reine Fabiola	Brussels		Belgium	1020

Sponsors and Collaborators

• Brugmann University Hospital

Investigators

• Principal Investigator: Denis Schmartz, MD, CHU Brugmann

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Denis SCHMARTZ, Head of Anesthesiology department, Brugmann University Hospital
• ClinicalTrials.gov Identifier: NCT04455776
• Other Study ID Numbers: CHUB_PEDIRM
• First Posted: Jul 2, 2020
• Last Update Posted: Aug 26, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Propofol

Study Results

No Results Posted as of Aug 26, 2020