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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 7, 2007

Last Updated Date

January 26, 2010

Start Date ^ICMJE

June 2007

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

to compare recovery time, complications and qulatiy of the MRI studies when continuous of propofol was used versus intermittent bolus dosing
to compare the dose of propofol used as a continuous infusion versus intermittent bolus dosing

Change History

Complete list of historical versions of study NCT00515359 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Encephalopathy
Developmental Delay and Behavioral Changes
Cord Tumor Compression or Instability
Cord Tethering or Malformation

Intervention ^ICMJE

Procedure: Intermittent Propofol Sedation
Intermittent versus continuous dosage
Procedure: Continuous Propofol Sedation
intermittent vs continuous dosage

Study Arm (s)

Active Comparator: Dose Comparison

continuous versus intermittent bolus dosing

Interventions:

Procedure: Intermittent Propofol Sedation
Procedure: Continuous Propofol Sedation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

500

Completion Date

February 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Month to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00515359

Other Study ID Numbers ^ICMJE

2007-140

Has Data Monitoring Committee

Responsible Party

Nabil Hassan, MD, Helen DeVos Children's Hospital

Study Sponsor ^ICMJE

Spectrum Health Hospitals

Collaborators ^ICMJE

Helen DeVos Children's Hospital

Investigators ^ICMJE

Principal Investigator:

Nabil Hassan, MD

Helen DeVos Children's Hospital

Information Provided By

Spectrum Health Hospitals

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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