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IBIS - Investigating Reliability of BIS and SEDLINE Monitoring in Children With Developmental and Epileptic Encephalopathies (DEE).
Sponsor: Telethon Kids Institute
Summary
When children have surgery, anaesthetists carefully monitor the depth of anaesthesia by using sensors on the forehead that measure brain activity, also known as processed electroencephalogram (pEEG). These monitors are routinely used in paediatric anaesthesia; however, investigators do not know if they work accurately in babies and young children with seizure disorders or on anti-seizure medications. Children with developmental and epileptic encephalopathies may need anaesthesia for tests or procedures. It is important that their treating doctors understand whether these monitors truly reflect how awake or asleep the children are. This study aims to compare a child's electrical brain activity using two commonly used devices in paediatric anaesthesia with the conventional 21-lead EEG patterns in children with seizure disorders. The results of this research may help improve the safety and perioperative care of children with seizure disorders who require general anaesthesia in the future.
Key Details
Gender
All
Age Range
0 Years - 15 Years
Study Type
OBSERVATIONAL
Enrollment
40
Start Date
2026-05-20
Completion Date
2029-06-20
Last Updated
2026-05-29
Healthy Volunteers
No
Conditions
Interventions
Monitoring of patients using electroencephalogram, a Bispectral Index (BIS) and Sedline monitors.
This is an observational study of children under 16 years of age, who will be fitted with a 21-lead EEG and then, in consecutive random order, a BIS or Sedline monitor with measurements taken for 30 minutes with each monitor, 60 min in total. This will allow pEEG data to be measured against a corresponding continuous EEG. The depth of anaesthesia monitors used are Bispectral Index (BIS, Medtronic, Minneapolis, Minnesota, USA) and Sedline (Masimo, Irvine, California, USA).
Locations (2)
Perth Children's Hospital
Perth, Western Australia, Australia
Hospital das Clinicas, São Paulo, Sao Paulo
São Paulo, Brazil