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

January 17, 2024 updated by: Spectrum Health Hospitals
RCT for Intermittent versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

276

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continuous Dosing
continuous dosing
Procedure: Continuous Propofol Sedation
intermittent vs continuous dosage
Active Comparator: Intermittent Dosing
Procedure: Intermittent Propofol Sedation
Intermittent versus continuous dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectrum Health Hospitals

Collaborators

Helen DeVos Children's Hospital

Investigators

  • Principal Investigator: Nabil Hassan, MD, Helen DeVos Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

August 7, 2007

First Submitted That Met QC Criteria

August 10, 2007

First Posted (Estimated)

August 13, 2007

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-140

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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