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 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT06303518
Eligibility Criteria:
Inclusion Criteria:
* Children aged 3 - 11 years undergoing non- or minimally-stimulating elective procedures, defined as anesthesia without skin incision or painful manipulation (e.g., non-invasive imaging, auditory brainstem response testing), middle ear surgery, surgery with effective local or regional anesthesia before surgical incision (e.g dental procedures with local anesthetic infiltration, urology with regional block).
* American Society of Anesthesiologists (ASA) physical status I and II
* TIVA technique appropriate throughout induction and maintenance of anesthesia
* Controlled ventilation via endotracheal tube
* Anticipated surgical time ≥ 90 minutes: to allow time for anesthetic induction and subsequent testing and washout periods at all three EtCO2 levels.
Exclusion Criteria:
* Need for inhalational induction of anesthesia
* Sedative premedication
* Use of ketamine intraoperatively
* Unable to place BIS electrodes due to surgical site or other contraindications (e.g., MRI)
* Allergy to study drugs (propofol, remifentanil, lidocaine)
* Depression of conscious level for any reason
* BMI \<5th or \>95th centile for age
* History of obstructive or central sleep apnea
* Known or suspected raised intracranial pressure
* Recent or historical traumatic brain injury
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
11 Years
Study:
NCT06303518
Study Brief:
Protocol Section:
NCT06303518