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 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT00909935
Eligibility Criteria:
Inclusion Criteria:
* Age 3 - 11.9 years
* 2 age groups: 3.0 - 5.9 years, 6.0 - 11.9 years
* Patients will be equally distributed within each age group
* Meets criteria to receive dexmedetomidine sedation for MRI:
* Active, uncontrolled gastroesophageal reflux - an aspiration risk
* Active, uncontrolled vomiting - an aspiration risk
* Current (or within past 3 months) history of apnea requiring an apnea monitor
* Active, current respiratory issues that are different from the baseline status (pneumonia,exacerbation of asthma, bronchiolitis, respiratory syncytial virus)
* Unstable cardiac status (life threatening arrhythmias, abnormal cardiac anatomy,significant cardiac dysfunction)
* Craniofacial anomaly, which could make it difficult to effectively establish a mask airway for positive pressure ventilation if needed
* Current use of digoxin
* Moya Moya Disease
* New-onset stroke
* Provide written consent to take part in the research study
Exclusion Criteria:
* Do not meet established sedation criteria
* History of allergy, intolerance, or reaction to dexmedetomidine or hypersensitivity
* Previous diagnosis of hepatic insufficiency/failure or a serum glutamate pyruvate transaminase level \> 2 times the normal limit determined by Children's Hospital Boston (TCH)
* Current diagnosis of renal insufficiency/failure or a current serum creatinine level \> 1.5 times the normal limit determined by TCH
* Have received digoxin in the past (no time limit)
* Received phenobarbital, clonidine or valproic acid within 30 days
* Current, repaired or risk of Moya-Moya disease
* Recent stroke (cerebrovascular accident) within past 6 months
* Uncontrolled hypertension
* Concomitant use of beta antagonist, or calcium channel blocker
* Participated in a clinical investigation within the past three months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
12 Years
Study:
NCT00909935
Study Brief:
Protocol Section:
NCT00909935