Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-24 @ 2:42 PM
NCT ID:
NCT00515359
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
18 Years
Study:
NCT00515359
Study Brief:
Protocol Section:
NCT00515359