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

Spectrum Health Hospitals

Status: Completed

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

Treatments: Procedure: Intermittent Propofol Sedation; Procedure: Continuous Propofol Sedation

Study type: Interventional

Funder types: Other

Identifiers

NCT00515359

2007-140

Details and patient eligibility

About

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

Full 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.

Enrollment: 276 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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276 participants in 2 patient groups

Continuous Dosing

Active Comparator group

Description:

continuous dosing

Treatment:

Procedure: Continuous Propofol Sedation

Intermittent Dosing

Active Comparator group

Description:

Intermittent Dosing

Treatment:

Procedure: Intermittent Propofol Sedation