NCT04455776

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

July 3, 2020

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

August 26, 2020

Status Verified

August 1, 2020

Enrollment Period

27 days

First QC Date

June 25, 2020

Last Update Submit

August 25, 2020

Conditions

Multiparametric Magnetic Resonance ImagingPropofol Adverse ReactionSedation ComplicationAnesthesia; Adverse Effect

Outcome Measures

Primary Outcomes (3)

  • Hypoxemia

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

    90 minutes

  • Hypercapnia

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

    90 minutes

  • Movements

    Number of patient movements interfering with the MRI exam

    90 minutes

Interventions

PropofolDRUG

Sedation by propofol

Eligibility Criteria

AgeUp to 16 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients under 16 years undergoing magnetic resonance imaging under propofol sedation.

You may qualify if:

  • Pediatric patients scheduled for MRI under sedation by an anaesthesiologist
  • Age \< 16 years

You may not qualify if:

  • Age \> 16 years
  • Sedation performed by a non-anesthesiologist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Universitaire des Enfants Reine Fabiola

Brussels, 1020, Belgium

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Denis Schmartz, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesiology department

Study Record Dates

First Submitted

June 25, 2020

First Posted

July 2, 2020

Study Start

July 3, 2020

Primary Completion

July 30, 2020

Study Completion

July 30, 2020

Last Updated

August 26, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)