NCT00515359

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

1.7 years

First QC Date

August 7, 2007

Last Update Submit

January 17, 2024

Conditions

EncephalopathyDevelopmental Delay and Behavioral ChangesCord Tumor Compression or InstabilityCord Tethering or Malformation

Keywords

SedationMRIpediatricpropofolbrainspinequality of MRIContinuous propofol dosingcontinuous propofol administrationIntermittent propofol dosingintermittent propofol administrationSedative agentpropofol continuous infusionsRecovery timeComplications of sedationbolus dosing

Outcome Measures

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

    study completion

Study Arms (2)

Continuous Dosing

ACTIVE COMPARATOR

continuous dosing

Procedure: Continuous Propofol Sedation

Intermittent Dosing

ACTIVE COMPARATOR

Intermittent Dosing

Procedure: Intermittent Propofol Sedation

Interventions

Intermittent Propofol SedationPROCEDURE

Intermittent versus continuous dosage

Intermittent Dosing
Continuous Propofol SedationPROCEDURE

intermittent vs continuous dosage

Continuous Dosing

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Related Links

MeSH Terms

Conditions

Brain DiseasesLearning DisabilitiesCongenital Abnormalities

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Nabil Hassan, MD

    Helen DeVos Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2007

First Posted

August 13, 2007

Study Start

June 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

January 19, 2024

Record last verified: 2024-01

Locations

US(1)