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

NCT ID: NCT00515359

Last Updated: 2024-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Continuous Dosing

continuous dosing

Group Type ACTIVE_COMPARATOR

Continuous Propofol Sedation

Intervention Type PROCEDURE

intermittent vs continuous dosage

Intermittent Dosing

Intermittent Dosing

Group Type ACTIVE_COMPARATOR

Intermittent Propofol Sedation

Intervention Type PROCEDURE

Intermittent versus continuous dosage

Interventions

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Intermittent Propofol Sedation

Intermittent versus continuous dosage

Intervention Type PROCEDURE

Continuous Propofol Sedation

intermittent vs continuous dosage

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helen DeVos Children's Hospital

OTHER

Sponsor Role collaborator

Spectrum Health Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nabil Hassan, MD

Role: PRINCIPAL_INVESTIGATOR

Helen DeVos Children's Hospital

Locations

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Spectrum Health

Grand Rapids, Michigan, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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2007-140

Identifier Type: -

Identifier Source: org_study_id

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