RCT for Intermittent Versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014