Status:
COMPLETED
Multi-center Isoelectric EEG Study in Children Under General Anesthesia
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Sydney Children's Hospitals Network
Royal Children's Hospital
Conditions:
Electroencephalography
General Anesthesia
Eligibility:
All Genders
Up to 36 years
Brief Summary
Multi-center, prospective, observational study investigating the incidence of isoelectric electroencephalography (EEG) events and the associated peri-operative factors in infants 0-3yo undergoing gene...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 21 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 27 2020
Estimated Enrollment :
687 Patients enrolled
Trial Details
Trial ID
NCT03432351
Start Date
June 21 2018
End Date
February 27 2020
Last Update
February 28 2020
Active Locations (15)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
2
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
3
Children's Medical Center Dallas
Dallas, Texas, United States, 75235
4
Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145