Skip to main content
OpenTrials
Completed

NCT Number: NCT03432351

Multi-center Isoelectric EEG Study in Children Under General Anesthesia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Electroencephalography General Anesthesia Pediatric Anesthesia

Age range

Up to 36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital at Westmead, Westmead, New South Wales, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of isoelectric EEG events in young children.

    Time frame: Up to 6 months after EEG recording

    Isoelectric EEG event is defined as low amplitude EEG for ≥ 2 seconds simultaneously across all 4 EEG channels.

Secondary outcomes

  1. Discontinuity of isoelectric EEG events among age groups

    Time frame: Up to 12 months after EEG recording.

    Patient age associated with isoelectric EEG events will be analyzed using a Pearson Chi square test to compare discontinuity of isoelectric EEG events among the age groups

  2. Association of isoelectric EEG events between gender groups

    Time frame: Up to 12 months after EEG recording

    Sample t-test or Wilcoxon rank-sum test, as appropriate will be used to analyze patient gender associated with isoelectric EEG events

  3. Patient Weight associated with isoelectric EEG events

    Time frame: Up to 12 months after EEG recording

    Weight (kg)

  4. Changes in patient's physical status associated with isoelectric EEG events

    Time frame: Up to 12 months after EEG recording

    Sample t-test or Wilcoxon rank-sum test, as appropriate, will be used to determine any association between the patient's physical status outcome associated with isoelectric EEG events.

  5. Patient Gestational Age associated with isoelectric EEG events

    Time frame: Up to 12 months after EEG recording

    Gestational Age (weeks)

  6. Procedure length associated with isoelectric EEG events

    Time frame: Up to 12 months after EEG recording.

    Procedure length (min)

  7. Incidence of anesthetic type

    Time frame: Up to 12 months after EEG recording.

    Sample t-test or Wilcoxon rank-sum test, as appropriate, will be used to determine incidence of anesthetic type (gas vs. TIVA) associated with isoelectric EEG events.

  8. Anesthesia dose

    Time frame: Up to 12 months after EEG recording.

    Sample t-test or Wilcoxon rank-sum test, as appropriate, will be used to determine variation in anesthesia dose associated with isoelectric EEG events.

  9. Heart rate associated with isoelectric EEG events

    Time frame: Up to 12 months after EEG recording.

    Sample t-test or Wilcoxon rank-sum test, as appropriate, will be used to determine variation in heart rate (beats per minute) associated with isoelectric EEG events.

  10. Blood pressure associated with isoelectric EEG events

    Time frame: Up to 12 months after EEG recording.

    Sample t-test or Wilcoxon rank-sum test, as appropriate, will be used to determine variation in blood pressure (mmHg) associated with isoelectric EEG events.

  11. End tidal carbon dioxide (CO2) associated with isoelectric EEG events.

    Time frame: Up to 12 months after EEG recording.

    Sample t-test or Wilcoxon rank-sum test, as appropriate, will be used to determine variation in end tidal CO2 (mmHg) associated with isoelectric EEG events.

  12. Anesthesia Recovery time associated with isoelectric EEG events.

    Time frame: Up to 12 months after EEG recording.

    Recovery time (min)

  13. Changes in quality of life

    Time frame: Up to 2 months after EEG recording

    The patient's parent or guardian will complete the PedsQL questionnaire, which measures pediatric quality of life. It consist of up to 45 questions for a total score ranging from 0 to 180. The lower the total score, the better the outcome.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Beijing Children's Hospital
  • Children's Hospital Medical Center, Cincinnati
  • Erasmus Medical Center
  • Guangzhou Women and Children's Medical Center
  • Princess Margaret Hospital for Children
  • Royal Children's Hospital
  • Shanghai Children's Medical Center
  • Shengjing Hospital
  • Sichuan Provincial People's Hospital
  • Sydney Children's Hospitals Network
  • University of Geneva, Switzerland
  • University of Texas Southwestern Medical Center
  • West China Hospital
  • Yuying Children's Hospital of Wenzhou Medical University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 14, 2018
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.