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Completed

NCT Number: NCT00515359

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

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

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Key information

Conditions

Encephalopathy Brain Diseases Central Nervous System Diseases Communication Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cord Tethering or Malformation Cord Tumor Compression or Instability Developmental Delay and Behavioral Changes Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent Propofol Sedation

Procedure

Intermittent versus continuous dosage

Continuous Propofol Sedation

Procedure

intermittent vs continuous dosage

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Corewell Health West

Other

Collaborators

  • Helen DeVos Children's Hospital

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 13, 2007
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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