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NCT00515359 Clinical Trial

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

Encephalopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00515359
Other study ID # 2007-140
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2007
Est. completion date February 2009

Study information
Verified date January 2024
Source Spectrum Health Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 276
Est. completion date February 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender All
Age group 1 Month to 18 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Spectrum Health Grand Rapids Michigan

Sponsors (2)
Lead Sponsor Collaborator
Spectrum Health Hospitals Helen DeVos Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary to compare recovery time, complications and quality of the MRI studies when continuous infusion of propofol was used versus intermittent bolus dosing study completion
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