search
Back to results

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

Primary Purpose

Encephalopathy, Developmental Delay and Behavioral Changes, Cord Tumor Compression or Instability

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intermittent Propofol Sedation
Continuous Propofol Sedation
Sponsored by
Spectrum Health Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Encephalopathy focused on measuring 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

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Spectrum Health

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Dose Comparison

Arm Description

continuous versus intermittent bolus dosing

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
August 7, 2007
Last Updated
January 26, 2010
Sponsor
Spectrum Health Hospitals
Collaborators
Helen DeVos Children's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00515359
Brief Title
RCT for Intermittent Versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies
Official Title
RCT for Intermittent Versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Spectrum Health Hospitals
Collaborators
Helen DeVos Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, continuous propofol administration, Intermittent propofol dosing, intermittent propofol administration, Sedative agent, propofol continuous infusions, Recovery time, Complications of sedation, bolus dosing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Comparison
Arm Type
Active Comparator
Arm Description
continuous versus intermittent bolus dosing
Intervention Type
Procedure
Intervention Name(s)
Intermittent Propofol Sedation
Intervention Description
Intermittent versus continuous dosage
Intervention Type
Procedure
Intervention Name(s)
Continuous Propofol Sedation
Intervention Description
intermittent vs continuous dosage
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nabil Hassan, MD
Organizational Affiliation
Helen DeVos Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs