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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Epileptic Encephalopathy; Infantile Spasm; Early Infantile Epileptic Encephalopathy; Developmental and Epileptic Encephalopathies
• Intervention / Treatment: Diagnostic test: Monitoring of patients using electroencephalogram, a Bispectral Index (BIS) and Sedline monitors.

Detailed Description

There is currently no available data on the reliability of processed electroencephalogram (pEEG) for adequately predicting depth of anaesthesia (DOA) with abnormal electroencephalogram (EEG) and those on anticonvulsant medication. Examples of epilepsy syndromes in which seizures and abnormal EEG (abnormal backgrounds: including excess discontinuity, excess slow, low amplitude, lack of sleep stages, and frequent epileptiform discharges) are predominant features are Early Infantile Developmental and Epileptic Encephalopathy (EIDEE), Epilepsy of infancy with Migrating Focal Seizures (EIMFS), Infantile Spasm Syndrome (IS) and other Epileptic encephalopathies (EE) and Developmental and Epileptic Encephalopathy (DEE). Considering the use of pEEG is common in paediatric anaesthesia and one of the strategies used to precent awareness and excessive anaesthesia provision, it would be pertinent to examine whether pEEG values truly reflect depth of sedation of these infants or if they are artificially low or high. To this end, investigators aim to concurrently measure EEG and pEEG patterns in infants with DEEs with onset in infancy and early childhood. Both pEEG patterns and their values will be measured with two commonly used monitors- the BiSpectral Index (BIS) and Sedline. Data from both pEEG monitors can then be directly compared with contemporaneous conventional EEG patterns on each patient.

This study will be conducted in collaboration with paediatric anaesthetists and neurologists in Perth Children's Hospital, Western Australia and the Hospital das Clínicas, Faculty of Medicine, University of São Paulo, Brazil. The target sample size is 40 participants- 20 from each centre. Participants will be invited to visit the hospital. Each awake participant will be fitted with a 16-lead EEG and additionally a BIS or Sedline monitor, applied consecutively in random order. The measurement period will be 30 minutes for each of the BIS and the Sedline with continuous EEG assessment throughout. This will allow the pEEG data to be measured against a corresponding continuous EEG.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Britta S von Ungern-Sternberg, MD, PhD; Phone Number: +61 8 6456 4806; Email: britta.regli-vonungern@health.wa.gov.au

Study Locations

• Australia
  • Western Australia
    • Perth, Western Australia, Australia, 6909
      • Perth Children's Hospital
      • Contact: Britta S von Ungern-Sternberg, MD, PhD; Phone Number: +61 8 6456 4806; Email: britta.regli-vonungern@health.wa.gov.au
      • Contact: Lliana Slevin, BSc; Phone Number: +61 426 952 977; Email: lliana.slevin@thekids.org.au
• Brazil
  • São Paulo, Brazil
    • Hospital das Clinicas, São Paulo, Sao Paulo
    • Contact: Vinícius Quintão, MD PHD; Phone Number: +55 11 2661 5795; Email: vinicius.quintao@hc.fm.usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

20 eligible patients identified by the neurology department at Perth Children's Hospital and 20 eligible patients identified by the neurology department at Hospital das Clinicas HCFMUSP, Faculdade de Medicina, will be approached for the study.

Description

Inclusion Criteria:

• Children (<16 years old) with a confirmed diagnosis of early onset EE or DEE due to any cause (prior to age 2 years).

Exclusion Criteria:

• Language barriers impeding data collection
• Department for Child Protection and Family Support is involved in the care of the child.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Children (<16 years) with confirmed diagnosis of early onset EE or DEE due to any cause; Children (<16 years old) with a confirmed diagnosis of early onset epileptic encephalopathy (EE) or Developmental and epileptic encephalopathy (DEE) due to any cause (prior to age 2 years).

Diagnostic test: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare pEEG values in awake patients with developmental and epileptic encephalopathies	pEEG will be measured using Sedline and BIS monitors alongside standard 21-lead EEG.	60 minutes of monitoring in total - Sedline and BIS monitors will be fitted for 30 minutes each, in consecutive random order.

Collaborators and Investigators

• Sponsor: Telethon Kids Institute
• Collaborators: Hospital das Clínicas de São Paulo - SP; Feculdade de Medicina da Universidade de Sao Paulo - Brasil; Child and Adolescent Health Service - Perth

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): May 20, 2029
• Study Completion (Estimated): June 20, 2029

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: anaesthesia; epileptic encepthalopathy; PILOT STUDY; MULTICENTRE
• Additional Relevant MeSH Terms: Epileptic Syndromes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy, Generalized; Epilepsy; Spasms, Infantile; Infantile Epileptic-Dyskinetic Encephalopathy
• Other Study ID Numbers: RGS0000008394

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No