EEG versus BIS monitoring to reduce emergence delirium in young children under general anaesthesia
Official title: Comparison of the Effect of EEG and BIS-guided Anaesthesia on the Incidence of Emergent Delirium in Children: a Prospective Monocentric Study
Run by University Hospital Ostrava · NCT07534215 · Data updated 2026-11-12
This study will test whether using EEG or BIS monitoring during general anaesthesia helps reduce emergence delirium in children aged 1–6 having surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Year to 6 Years |
| Sex | All |
| Enrollment | 540 (estimated) |
| Sponsor | University Hospital Ostrava Academic / other |
| Locations | 1 site (Ostrava, Moravian-Silesian Region) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | October 2028 |
| Study ends | December 2028 |
| Registry record updated | April 21, 2026 |
| Trial ID | NCT07534215 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 1–6 years scheduled for elective procedures such as hernioplasty or orchidopexy with ASA physical status I–II and parental or guardian consent.
✕Probably not a fit
Children older than 6, those with ASA III or higher, neurological disease, severe hearing or vision impairment, or whose parents do not consent are not eligible and would not benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Children aged 1–6 undergoing elective procedures receive a standardized anaesthesia protocol including oral midazolam premedication and measures of preoperative anxiety (PSAS and m‑YPAS). During anaesthesia they are managed either with EEG-guided titration of sevoflurane interpreted by an EEG specialist or with BIS monitoring targeting BIS values of 40–60. Airway management (laryngeal mask or intubation) and intraoperative analgesia are provided per protocol, and the time to initiation of depth monitoring is recorded. The primary outcome is the incidence of emergence delirium in the immediate postoperative period.
Why it matters
Potential benefit: If successful, the monitoring approach could reduce how often and how severely children experience emergence delirium, making recovery smoother and less distressing for patients and families.
How similar studies have gone: BIS- and EEG-guided anaesthesia have shown reductions in delirium or excessive anaesthetic depth in adult studies, but pediatric evidence—especially in very young children—is limited and mixed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged 1-6 years indicated for surgery (hernioplasty, orchidopexy) * Consent of parents/legal guardians * Health status corresponding to ASA (American Society of Anesthesiologists) I and II Exclusion Criteria: * Disagreement of parents/legal guardians with inclusion in the study * Neurological disease, severe hearing and vision impairment * Health status corresponding to ASA (American Society of Anesthesiologists) III and above
Where it's running
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University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia Recruiting
Study contacts
- Principal investigator: Vilém Novák, MD, Ph.D. — University Hospital Ostrava
- Study coordinator: Jiří Hynčica
- Email: jiri.hyncica@fno.cz
- Phone: +42059737
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.