Multi-center Isoelectric EEG Study in Children Under General Anesthesia

Completed

Conditions studied: Electroencephalography, General Anesthesia, Pediatric Anesthesia

In brief

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.

Key facts

Study ID

NCT03432351

Run by

Children's Hospital of Philadelphia

People needed

687

Starts

2018-06-21

Expected to finish

2020-02-27

Last updated by the study team

2020-02-28

Who can join

Age: any, up to 3. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Medical Center Dallas — Dallas, Texas, United States
• Children's Hospital at Westmead — Westmead, New South Wales, Australia
• Royal Children's Hospital (RCH, Melbourne, Australia) — Parkville, Victoria, Australia
• Princess Margaret Hospital for Children (PMH, Perth, Australia) — Subiaco, Western Australia, Australia
• Beijing Children's Hospital/Capital Medical University — Beijing, Beijing Municipality, China
• Guangzhou Women and Children's Medical Center — Guangzhou, Guangdong, China
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China
• Shanghai Jiao Tong university school of medicine / Shanghai Children's Medical Center — Shanghai, Shanghai Municipality, China
• West China Hospital, Sichuan University, China — Chengdu, Sichuan, China
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China
• The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China
• Erasmus MC Sophia Children's Hospital — Rotterdam, Netherlands
• University of Geneva — Geneva, Switzerland

Full record on ClinicalTrials.gov

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