CompletedNot Applicable

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

United States276 participantsStarted 2007-06

Plain-language summary

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

Who can participate

Age range

1 Month – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

to compare recovery time, complications and quality of the MRI studies when continuous infusion of propofol was used versus intermittent bolus dosing

Timeframe: study completion

Trial details

NCT IDNCT00515359

SponsorCorewell Health West

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-02

View on ClinicalTrials.gov More Encephalopathy trials

Who can participate

Age range

1 Month – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.