Multi-center Isoelectric EEG Study in Children Under General Anesthesia

An International Multicenter Study of Isoelectric EEG Events in Infants and Young Children During Anesthesia for Surgery

Multi-center, prospective, observational study investigating the incidence of isoelectric electroencephalography (EEG) events and the associated peri-operative factors in infants 0-3yo undergoing general anesthesia.

Study will consist of placing a forehead EEG on the subject prior to induction of general anesthesia. EEG recording will continue until the end of anesthesia care. The anesthesiologist will be blinded to the EEG results during the study. Peri-operative factors such as demographics, vital signs, medications, etc... will also be recoded. Each site is expected to enroll up to 75 patients to provide at least 50 evaluable subjects. EEG files will be reviewed after recordings.

After informed consent has been obtained, the subject will receive standard anesthetic care as administered by the anesthesia provider, who will be blinded to the EEG display and data. EEG recording will continue until the end of anesthesia care.

After the recording, the EEG file will be reviewed and the number and duration of isoelectric events will be analyzed. Additional data that will be recorded include: patient demographic and perioperative factors (surgical procedure, anesthetic medications, end tidal anesthetic levels, induction and recovery room behavior, physiologic data, and time-stamps for intraoperative event. Post-operative questionnaire may also be sent to parents.

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