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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT02395094
Eligibility Criteria:
Inclusion Criteria:
* Undergoing elective day surgery under general anesthesia, expected to last ≤ 2 hours
* ASA I to III
* Ages 3 - 10y
* Written parental/guardian informed consent and subject informed assent when required (subject age ≥ 7 years)
Exclusion Criteria:
* Previous surgery
* Severe anxiety (according to the staff anesthesiologist) in the preoperative period, requiring sedative pre-medication
* Severe anxiety in the preoperative period, deemed to require intervention by Child Life
* Anticipated mask induction of anesthesia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
10 Years
Study:
NCT02395094
Study Brief:
Protocol Section:
NCT02395094