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:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT05619627
Eligibility Criteria:
Inclusion Criteria:
1. Participants 3-6 years old, male and female, all races and ethnicities
2. Requiring a clinically indicated MRI with general anesthesia
Exclusion Criteria:
1. Refusal to take oral dexmedetomidine
2. Known allergy to dexmedetomidine
3. Inability to take dexmedetomidine at least 90 minutes prior to start of the MRI
4. Medical contraindications to administration of dexmedetomidine including:
1. Unstable cardiac status including life threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction
2. Current use of digoxin
3. Moya Moya disease
4. New onset stroke
5. American Society of Anesthesiologists (ASA) physical status classification \> II
6. Contraindications to administering sedation including:
1. Active and uncontrolled gastroesophageal reflux
2. Active and uncontrolled vomiting
3. Current or recent history of apnea
4. Active respiratory disease including pneumonia, bronchitis, respiratory syncytial virus infection, asthma exacerbation
5. Craniofacial anomalies
7. Inability to have MRI scans
8. Non-English speaking volunteers
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
6 Years
Study:
NCT05619627
Study Brief:
Protocol Section:
NCT05619627