EncephalopathyNCT00515359
RCT for Intermittent Versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies
A study testing Intermittent Propofol Sedation and Continuous Propofol Sedation in people with Encephalopathy and Developmental Delay and Behavioral Changes, run by Corewell Health West at 1 site in United States.
Trial summary
RCT for Intermittent versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Encephalopathy, Developmental Delay and Behavioral Changes, Cord Tumor Compression or Instability
- What is being tested?
- Intermittent Propofol Sedation and Continuous Propofol Sedation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Feb 2009
- Phase
- Interventional
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 1 month to 18 years
- Receiving a brain or spine MRI with propofol sedation
- Deemed safe to undergo sedation with propofol based on a pre-sedation examination
- Patient judged not to require any pre-medication with any other medication except nasal decongestants or anticholinergic medications
Who cannot join
- Patient below or above set age limits.
- Patient requires MRI studies on other body areas.
- Patient requires pre-medication with a sedative or tranquilizer
- Patient requires additional medications during sedation to complete the procedure.
- Propofol is being used as a rescue sedative to complete the procedure.
- Propofol is being used as a rescue sedative to complete a procedure that was initiated by another sedative.
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- Patients who develop complications that require termination of the imaging procedure will not be included in the dose or recovery time calculations, but the complication will be counted as such in their respective group and study will be reported as non-diagnostic.
- Insulin dependent diabetes
- Thyroid disease
Trial locations and contacts
1 site in 1 country.
About this study
RCT for Intermittent versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies
Read the detailed description
A study comparing the dose of propofol used as a continuous infusion versus intermittent bolus dosing looking at recovery time complications, and quality of the MRI studies in Pediatric Sedation Services for patients age 1 month to 18 years receiving an brain or spine MRI.
- Conditions
- Encephalopathy, Developmental Delay and Behavioral Changes, Cord Tumor Compression or Instability, Cord Tethering or Malformation
- Being tested
- Intermittent Propofol Sedation, Continuous Propofol Sedation
- Keywords
- Sedation, MRI, pediatric, propofol, brain, spine, quality of MRI, Continuous propofol dosing, continuous propofol administration, Intermittent propofol dosing, intermittent propofol administration, Sedative agent, propofol continuous infusions, Recovery time, Complications of sedation, bolus dosing
- Medical subject headings
- Brain Diseases, Learning Disabilities, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Propofol SedationProcedure or surgery
Intermittent versus continuous dosage
Continuous Propofol SedationProcedure or surgery
intermittent vs continuous dosage
| Study group | Role | What they receive |
|---|---|---|
| Continuous Dosing | Active comparator | continuous dosing Receives: Procedure: Continuous Propofol Sedation |
| Intermittent Dosing | Active comparator | Intermittent Dosing Receives: Procedure: Intermittent Propofol Sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare recovery time, complications and quality of the MRI studies when continuous infusion of propofol was used versus intermittent bolus dosing
Measured: study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2007 (estimated)
- Study startJun 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EncephalopathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Collaborators
- Helen DeVos Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Nabil Hassan, MD, Principal investigator, Helen DeVos Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515359
- Sponsor's protocol ID
- 2007-140
- Status last verified
- Jan 2024
- First submitted
- 7 Aug 2007
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT for Intermittent Versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies
- ClinicalTrials.gov ID
- NCT00515359
- Acronym / sponsor ID
- 2007-140
- Conditions
- Encephalopathy, Developmental Delay and Behavioral Changes, Cord Tumor Compression or Instability, Cord Tethering or Malformation
- Keywords
- Sedation, MRI, pediatric, propofol, brain, spine, quality of MRI, Continuous propofol dosing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Collaborators
- Helen DeVos Children's Hospital
- Study start
- Jun 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 13 Aug 2007 (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.
RCT for Intermittent versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies
Detailed description
A study comparing the dose of propofol used as a continuous infusion versus intermittent bolus dosing looking at recovery time complications, and quality of the MRI studies in Pediatric Sedation Services for patients age 1 month to 18 years receiving an brain or spine MRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Dosing | Active comparator | Procedure: Continuous Propofol Sedationcontinuous dosing |
| Intermittent Dosing | Active comparator | Procedure: Intermittent Propofol SedationIntermittent Dosing |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 1 month to 18 years
- Receiving a brain or spine MRI with propofol sedation
- Deemed safe to undergo sedation with propofol based on a pre-sedation examination
- Patient judged not to require any pre-medication with any other medication except nasal decongestants or anticholinergic medications
Key exclusion criteria (9 listed)
- Patient below or above set age limits.
- Patient requires MRI studies on other body areas.
- Patient requires pre-medication with a sedative or tranquilizer
- Patient requires additional medications during sedation to complete the procedure.
- Propofol is being used as a rescue sedative to complete the procedure.
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 |
|---|---|---|
| Intermittent Propofol SedationIntermittent versus continuous dosage | Procedure or surgery | Intermittent Dosing |
| Continuous Propofol Sedationintermittent vs continuous dosage | Procedure or surgery | Continuous Dosing |
Primary outcome
to compare recovery time, complications and quality of the MRI studies when continuous infusion of propofol was used versus intermittent bolus dosing
Time frame: study completion
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 19 Jan 2024.
- Spectrum HealthLink provided by the sponsor.
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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.
Nabil Hassan, MD principal investigator
Helen DeVos Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Propofol Sedation and Continuous Propofol Sedation in people with Encephalopathy and Developmental Delay and Behavioral Changes, run by Corewell Health West at 1 site in United States.
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 4 inclusion and 9 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 19 Jan 2024. 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 United States. 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?
to compare recovery time, complications and quality of the MRI studies when continuous infusion of propofol was used versus intermittent bolus dosing (time frame: study completion). 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 19 Jan 2024.