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 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT04273035
Eligibility Criteria:
Inclusion criteria
* Age ≥ 1 year and \<8 years old
* ASA class 1 or 2 (American Society of Anesthesiologists Physical Status Classification System)
* Elective circumcision, tonsillectomy or adenoidectomy, dental care procedure in day-care
* Written informed consent by the legal parents or caretaker
Exclusion criteria
* Parents of the patient wish not to participate with the study
* Parents are not able to give informed consent (language barrier, legally incapable)
* A contraindication for the use of premedication with midazolam
* A known allergy to midazolam
* A contraindication for premedication in general
* A contraindication for the use of a gas-induction/gas-anesthesia
* A contraindication for the use of sevoflurane
* A known mental retardation of the child
* Preoperative behavioral disturbances and psychiatric disorders
* Any use of psychoactive medication
* A known photosensitive epilepsy
* A previous operation within 3 months of the time of scheduled operation
* Any other contraindication for the use of the study medication
* Previous history of multiple surgery (\>3)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
8 Years
Study:
NCT04273035
Study Brief:
Protocol Section:
NCT04273035