RCT for Intermittent Versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies
This study has been completed.
Sponsor:
Spectrum Health Hospitals
Collaborator:
Helen DeVos Children's Hospital
Information provided by:
Spectrum Health Hospitals
ClinicalTrials.gov Identifier:
NCT00515359
First received: August 7, 2007
Last updated: January 26, 2010
Last verified: December 2009
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Purpose
RCT for Intermittent versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies
| Condition | Intervention |
|---|---|
|
Encephalopathy Developmental Delay and Behavioral Changes Cord Tumor Compression or Instability Cord Tethering or Malformation |
Procedure: Intermittent Propofol Sedation Procedure: Continuous Propofol Sedation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | RCT for Intermittent Versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies |
Resource links provided by NLM:
Further study details as provided by Spectrum Health Hospitals:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | June 2007 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Dose Comparison
continuous versus intermittent bolus dosing
|
Procedure: Intermittent Propofol Sedation
Intermittent versus continuous dosage
Procedure: Continuous Propofol Sedation
intermittent vs continuous dosage
|
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.
Eligibility| Ages Eligible for Study: | 1 Month to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515359
Locations
| United States, Michigan | |
| Spectrum Health | |
| Grand Rapids, Michigan, United States, 49503 | |
Sponsors and Collaborators
Spectrum Health Hospitals
Helen DeVos Children's Hospital
Investigators
| Principal Investigator: | Nabil Hassan, MD | Helen DeVos Children's Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Nabil Hassan, MD, Helen DeVos Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT00515359 History of Changes |
| Other Study ID Numbers: | 2007-140 |
| Study First Received: | August 7, 2007 |
| Last Updated: | January 26, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Spectrum Health Hospitals:
|
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 |
Additional relevant MeSH terms:
|
Congenital Abnormalities Brain Damage, Chronic Delirium Encephalitis Hepatic Encephalopathy Neurotoxicity Syndromes Brain Diseases Central Nervous System Diseases Nervous System Diseases Confusion Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
Central Nervous System Viral Diseases Virus Diseases Central Nervous System Infections Liver Failure Hepatic Insufficiency Liver Diseases Digestive System Diseases Brain Diseases, Metabolic Metabolic Diseases Poisoning Substance-Related Disorders Propofol Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on May 19, 2013