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 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT03637257
Eligibility Criteria:
Inclusion Criteria:
* Term born infants aged 4 to 24 months
* Physical status according classification I or II (American Society of Anaesthesiologists (ASA))
* Scheduled for elective diagnostic/therapeutic procedures or surgery under sedation/anaesthesia
* Informed Consent as documented by signature of the parents or legal caregiver
Exclusion Criteria:
* syndrome that affects the airway anatomy
* Physical status according classification III or IV (American Society of Anaesthesiologists (ASA))
* Upper respiratory tract infection at present or within the last two weeks before the study
* Previous enrolment into the current study
* Known hypersensitivity or allergic reactions to midazolam, nitrous oxide (N2O), Propofol or Sevoflurane.
* Positive Family History for malignant hyperthermia, Morbus Pompe or ophthalmic operations with gas injection or Sinus- or inner ear surgery.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Months
Maximum Age:
24 Months
Study:
NCT03637257
Study Brief:
Protocol Section:
NCT03637257