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 @ 3:40 PM
Ignite Modification Date:
2025-12-24 @ 3:40 PM
NCT ID:
NCT04237792
Eligibility Criteria:
Key Inclusion Criteria:
1. Male or female subject ≥1 month and \<17 years of age.
2. American Society of Anesthesiologists (ASA) Physical Status I, II or III.
3. Requires non-intubated, spontaneous breathing, moderate to deep sedation (NI MDS) for a magnetic resonance imaging (MRI) study with an intensivist, anesthesiologist or other proceduralist in attendance.
4. Duration of the MRI scan is expected to take at least 20 minutes but no more than 3 hours to complete
Key Exclusion Criteria:
1. Pregnant female subjects (including those with an indeterminate or positive pregnancy test); breastfeeding female subjects.
2. Weight on Day 1 before randomization is less than the 10th percentile of weight for age and sex in the US and Japan or is greater than the 95th percentile of weight for age and sex in the US or greater than the 97th percentile of weight for age and sex in Japan based on sponsor-provided growth charts.
3. Planned medical procedure during the MRI scan or post-MRI recovery period.
4. Requires endotracheal intubation or laryngeal mask airway (LMA).
5. Known allergy to eggs, egg products, soybeans or soybean products.
6. SpO2 \<93 % on room air -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
16 Years
Study:
NCT04237792
Study Brief:
Protocol Section:
NCT04237792