Clinical Trial

IBIS - Investigating Reliability of BIS and SEDLINE Monitoring in Children With Developmental and Epileptic Encephalopathies (DEE).

Study acronym: IBIS
Not Yet Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2029-05-20 -> 2029-09-03 2026-07-19
minor Completion pushed: 2029-06-20 -> 2029-09-04 2026-07-19
Trial Details
NCT Number NCT07585643
Lead Sponsor Telethon Kids Institute
Collaborators: Child and Adolescent Health Service - Perth, Feculdade de Medicina da Universidade de Sao Paulo - Brasil, University of Sao Paulo General Hospital
Conditions Epileptic Encephalopathy, Early Infantile Epileptic Encephalopathy, Infantile Spasm, Developmental and Epileptic Encephalopathies
Enrollment 40 participants
Start Date 2026-09-03
Primary Completion 2029-09-03 (estimated)
Study Completion 2029-09-04 (estimated)
Updated on ClinicalTrials.gov 2026-07-17