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

NCT07585643 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-05-14

No results posted yet for this study

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, we 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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • Child and Adolescent Health Service - Perth

    collaborator OTHER_GOV

  • Feculdade de Medicina da Universidade de Sao Paulo - Brasil

    collaborator OTHER

  • Hospital das Clínicas de São Paulo - SP

    collaborator UNKNOWN

  • Telethon Kids Institute

    lead OTHER

Eligibility

Min Age
0 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-20
Primary Completion
2029-05-20
Completion
2029-06-20

Countries

  • Australia
  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07585643 on ClinicalTrials.gov