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

Not Applicable

Completed

• Conditions: Encephalopathy; Developmental Delay and Behavioral Changes; Cord Tumor Compression or Instability; Cord Tethering or Malformation
• Interventions: Procedure: Intermittent Propofol Sedation; Procedure: Continuous Propofol Sedation

• Registration Number: NCT00515359
• Lead Sponsor: Spectrum Health Hospitals

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 Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-08-07
• Study First Submitted QC: 2007-08-10
• Study First Posted: 2007-08-13
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent Dosing	Intermittent Propofol Sedation	Intermittent Dosing
Continuous Dosing	Continuous Propofol Sedation	continuous dosing

Primary Outcome Measures

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

Trial Locations

Locations (1)

Spectrum Health; 🇺🇸 Grand Rapids, Michigan, United States