EEG versus BIS monitoring to reduce emergence delirium in young children under general anaesthesia
Comparison of the Effect of EEG and BIS-guided Anaesthesia on the Incidence of Emergent Delirium in Children: a Prospective Monocentric Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 540 (estimated) |
| Ages | 1 Year to 6 Years |
| Sex | All |
| Sponsor | University Hospital Ostrava Academic / other |
| Locations | 1 site (Ostrava, Moravian-Silesian Region) |
| Trial ID | NCT07534215 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Ostrava, Moravian-Silesian Region
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.