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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT03432351
Eligibility Criteria:
Inclusion Criteria:
* Age 0 to 36 (inclusive) months
* Greater than 36 weeks post-menstrual age (PMA) on the day of study
* Undergo general anesthesia for surgery that is expected to last more than 30 minutes (combined anesthesia and surgical time).
* Anesthetic maintenance with Sevoflurane if using volatile anesthetic or Propofol infusion if using total intravenous anesthetic.
* Expected airway management with a Laryngeal Mask Airway (LMA) or tracheal tube.
* Parental/legal guardian permission (informed consent) obtained
Exclusion Criteria:
* American Society of Anesthesiology (ASA) (physical status) greater than 3
* Structural/anatomical frontal brain malformations or other circumstances that make it difficult to apply the sensor to the forehead.
* History of abnormal EEG or severe neurological abnormalities.
* Scheduled for surgery above the neck, cardiac, brain, or emergency surgery.
* Known allergy or adverse reaction to ECG adhesives.
* On a sedative infusion (eg, propofol, morphine, fentanyl, midazolam, dexmedetomidine, ketamine) or recently on a sedative infusion (discontinued \<24 hours ago)
* Received ketamine within 8 hours prior to the induction of general anesthesia
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
36 Months
Study:
NCT03432351
Study Brief:
Protocol Section:
NCT03432351