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 @ 2:43 PM
Ignite Modification Date:
2025-12-24 @ 2:43 PM
NCT ID:
NCT01344759
Eligibility Criteria:
Inclusion Criteria:
1. Patients with documented history of OSA by polysomnography who require anesthesia for MRI sleep study or MRI brain imaging study.
2. Subjects must be 12 months to 25 years of age (inclusive)
3. Either the subject (if subject's age is 18-25) or the subject's legally authorized representative has given written informed consent to participate in the study
Exclusion Criteria:
1. The subject has life-threatening medical conditions (American Society of Anesthesiologists Physical Status 4, 5 or 6). The American Society of Anesthesiologists (ASA) classification scale is a measure of physical status or how healthy the patient is. For our study, we will focus on children which are defined as ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease that is mild and well controlled (ASA II) or a child with systemic disease that is severe and controlled (ASA III).
2. The subject is allergic to or has a contraindication to propofol or dexmedetomidine.
3. The subject has a tracheostomy or other mechanical airway device
4. The subject is not scheduled to receive anesthesia-sedation care for the MRI
5. The subject has a history or a family (parent or sibling) history of malignant hyperthermia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
25 Years
Study:
NCT01344759
Study Brief:
Protocol Section:
NCT01344759