Multiparametric Magnetic Resonance ImagingNCT04455776
Safety Evaluation of Propofol Sedation for Magnetic Resonance Imaging in Pediatric Patients
An observational study of Multiparametric Magnetic Resonance Imaging and Propofol Adverse Reaction, run by Brugmann University Hospital at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Multiparametric Magnetic Resonance Imaging, Propofol Adverse Reaction, Sedation Complication
- What is being tested?
- Propofol
- How many people
- 99 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Jul 2020to 30 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- Child
Study population: Pediatric patients under 16 years undergoing magnetic resonance imaging under propofol sedation.
Who may be able to join
- Pediatric patients scheduled for MRI under sedation by an anaesthesiologist
- Age < 16 years
Who cannot join
- Age > 16 years
- Sedation performed by a non-anesthesiologist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Adverse Events During Propofol Sedation for Magnetic Resonance Imaging in Pediatric Patients
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Sedation by propofol
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxemia
Arterial desaturation defined as number of episodes with an SpO2≤94%
Measured: 90 minutes
Hypercapnia
Hypercapnia, defined as number of episodes with an ETCO2 > 45 mm HG
Measured: 90 minutes
Movements
Number of patient movements interfering with the MRI exam
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start3 Jul 2020
- Primary completion30 Jul 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiparametric Magnetic Resonance ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis SCHMARTZ, Brugmann University Hospital
- Investigators
- Denis Schmartz, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455776
- Sponsor's protocol ID
- CHUB_PEDIRM
- Status last verified
- Aug 2020
- First submitted
- 25 Jun 2020
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Adverse Events During Propofol Sedation for Magnetic Resonance Imaging in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04455776
- Acronym / sponsor ID
- CHUB_PEDIRM
- Conditions
- Multiparametric Magnetic Resonance Imaging, Propofol Adverse Reaction, Sedation Complication, Anesthesia; Adverse Effect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- Pediatric patients under 16 years undergoing magnetic resonance imaging under propofol sedation.
Key inclusion criteria (2 listed)
- Pediatric patients scheduled for MRI under sedation by an anaesthesiologist
- Age < 16 years
Key exclusion criteria (2 listed)
- Age > 16 years
- Sedation performed by a non-anesthesiologist
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolSedation by propofol | Drug | – |
Primary outcome
Hypoxemia
Time frame: 90 minutes
Arterial desaturation defined as number of episodes with an SpO2≤94%
Hypercapnia
Time frame: 90 minutes
Hypercapnia, defined as number of episodes with an ETCO2 > 45 mm HG
Movements
Time frame: 90 minutes
Number of patient movements interfering with the MRI exam
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Schmartz, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiparametric Magnetic Resonance Imaging and Propofol Adverse Reaction, run by Brugmann University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxemia (time frame: 90 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2020.