Children Requiring Sedation for MRI/CTNCT01855555
The Incidence and Nature of Adverse Events During Pediatric Sedation for MRI/CT in One Korean University Hospital: Prospective Study
An observational study of Children Requiring Sedation for MRI/CT, run by Yonsei University at 1 site in South Korea.
Trial summary
Sedation and anesthesia for which to perform diagnostic imaging represents a rapidly growing field of practice, especially in children. Propofol is the most common sedative drug administered for MRI/CT. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Children Requiring Sedation for MRI/CT
- What is being tested?
- sedation with propofol
- How many people
- 2,948 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to Nov 2014
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children requiring sedation for MRI/CT
Who may be able to join
- Requiring sedation for MRI/CT, aged 0- 18 years
Who cannot join
- Parent refusal of participation
Trial locations and contacts
1 site in 1 country.
About this study
Sedation and anesthesia for which to perform diagnostic imaging represents a rapidly growing field of practice, especially in children. Propofol is the most common sedative drug administered for MRI/CT. However, this drug is associated with adverse events, including pulmonary complications, and there has been no report on these complications in Korea. In this prospective observation study, the investigators will report the nature and frequency of adverse events associated with propofol-based sedation for MRI/CT.
- Conditions
- Children Requiring Sedation for MRI/CT
- Being tested
- sedation with propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sedation with propofolDrug
When a patient is admitted to the Pediatric Sedation Center, a presedation assessment is performed by hospitalists. Then Pediatric sedation is performed by protocol in the sedation unit.
Data on demographics, primary illness, ASA, snoring history, URI symptom, medications used, procedure and recovery times, medication doses, outcomes of anesthesia, airway interventions and adverse events will be reported.
| Study group | Role | What they receive |
|---|---|---|
| sedation group | Children requiring sedation for MRI/CT Receives: Drug: sedation with propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events
The investigators will record all adverse events that are associated with pediatric sedation for MRI/CT
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Children Requiring Sedation for MRI/CTStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 2,948 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855555
- Sponsor's protocol ID
- 4-2012-0688
- Status last verified
- Jan 2015
- First submitted
- 9 May 2013
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cravero JP, Beach ML, Blike GT, Gallagher SM, Hertzog JH; Pediatric Sedation Research Consortium. The incidence and nature of adverse events during pediatric sedation/anesthesia with propofol for procedures outside the operating room: a report from the Pediatric Sedation Research Consortium. Anesth Analg. 2009 Mar;108(3):795-804. doi: 10.1213/ane.0b013e31818fc334.
PubMed 19224786
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence and Nature of Adverse Events During Pediatric Sedation for MRI/CT in One Korean University Hospital: Prospective Study
- ClinicalTrials.gov ID
- NCT01855555
- Acronym / sponsor ID
- 4-2012-0688
- Conditions
- Children Requiring Sedation for MRI/CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,948 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 16 May 2013 (estimated)
- 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.
Sedation and anesthesia for which to perform diagnostic imaging represents a rapidly growing field of practice, especially in children. Propofol is the most common sedative drug administered for MRI/CT. However, this drug is associated with adverse events, including pulmonary complications, and there has been no report on these complications in Korea. In this prospective observation study, the investigators will report the nature and frequency of adverse events associated with propofol-based sedation for MRI/CT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sedation group | – | Drug: sedation with propofolChildren requiring sedation for MRI/CT |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children requiring sedation for MRI/CT
Key inclusion criteria (1 listed)
- Requiring sedation for MRI/CT, aged 0- 18 years
Key exclusion criteria (1 listed)
- Parent refusal of participation
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 |
|---|---|---|
| sedation with propofolWhen a patient is admitted to the Pediatric Sedation Center, a presedation assessment is performed by hospitalists. Then Pediatric sedation is performed by protocol in the sedation unit. Data on demographics, primary illness, ASA, snoring history, URI symptom, medications used, procedure and recovery times, medication doses, outcomes of anesthesia, airway interventions and adverse events will be reported. | Drug | sedation group |
Primary outcome
Frequency of Adverse Events
Time frame: 24 hours
The investigators will record all adverse events that are associated with pediatric sedation for MRI/CT
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 21 Jan 2015.
- Background: PubMed 19224786Cravero JP, Beach ML, Blike GT, Gallagher SM, Hertzog JH; Pediatric Sedation Research Consortium. The incidence and nature of adverse events during pediatric sedation/anesthesia with propofol for procedures outside the operating room: a report from the Pediatric Sedation Research Consortium. Anesth Analg. 2009 Mar;108(3):795-804. doi: 10.1213/ane.0b013e31818fc334.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Children Requiring Sedation for MRI/CT, run by Yonsei University at 1 site in South Korea.
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 1 inclusion and 1 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 21 Jan 2015. 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 South Korea. 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?
Frequency of Adverse Events (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01855555, which also lists 1 linked publication.
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 21 Jan 2015.