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


N/A
1 Month
18 Years
Not Enrolling
Both
Encephalopathy, Developmental Delay and Behavioral Changes, Cord Tumor Compression or Instability, Cord Tethering or Malformation

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

study completion

Safety Issue:

No

Principal Investigator

Nabil Hassan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Helen DeVos Children's Hospital

Authority:

United States: Institutional Review Board

Study ID:

2007-140

NCT ID:

NCT00515359

Start Date:

June 2007

Completion Date:

February 2009

Related Keywords:

  • Encephalopathy
  • Developmental Delay and Behavioral Changes
  • Cord Tumor Compression or Instability
  • Cord Tethering or Malformation
  • 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
  • Congenital Abnormalities
  • Brain Damage, Chronic
  • Delirium
  • Encephalitis
  • Hepatic Encephalopathy
  • Neurotoxicity Syndromes

Name

Location

Spectrum HealthGrand Rapids, Michigan  49503