RCT for Intermittent Versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies
NCT ID: NCT00515359
Last Updated: 2024-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
276 participants
INTERVENTIONAL
2007-06-30
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Continuous Dosing
continuous dosing
Continuous Propofol Sedation
intermittent vs continuous dosage
Intermittent Dosing
Intermittent Dosing
Intermittent Propofol Sedation
Intermittent versus continuous dosage
Interventions
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Intermittent Propofol Sedation
Intermittent versus continuous dosage
Continuous Propofol Sedation
intermittent vs continuous dosage
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* 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
1 Month
18 Years
ALL
No
Sponsors
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Helen DeVos Children's Hospital
OTHER
Spectrum Health Hospitals
OTHER
Responsible Party
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Principal Investigators
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Nabil Hassan, MD
Role: PRINCIPAL_INVESTIGATOR
Helen DeVos Children's Hospital
Locations
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Spectrum Health
Grand Rapids, Michigan, United States
Countries
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Related Links
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Spectrum Health
Other Identifiers
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2007-140
Identifier Type: -
Identifier Source: org_study_id
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