Comparison of the Effect of EEG and BIS-guided Anaesthesia on the Incidence of Emergent Delirium in Children: a Prospective Monocentric Study

NCT07534215 | Recruiting

• 2 other identifiers: BisEEg study17/RVO-FNOs/2026
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare two modalities of measuring the depth of general anaesthesia on the incidence of emergent delirium in children.

Conditions

Emergence Delirium, Anesthesia

Keywords

Emergence Delirium; EEG; Bispectral Index; General anaesthesia

Outcome Measures

Primary Outcomes (3)

• Presence of ED (in EEG and BIS groups) - PAED scale

  The presence of emergence delirium in the EEG and BIS groups will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale at the recovery room. The Pediatric Anesthesia Emergence Delirium (PAED) Scale is a 5-item, validated observational tool used to measure the severity of delirium in children during anesthesia recovery, with scores \>10-12 indicating significant emergence delirium (ED).

  2 hours after surgery

• Presence of ED (in EEG and BIS groups) - Watcha scale

  The presence of emergence delirium in the EEG and BIS groups will be assessed using the Watcha scale at the recovery room. The Watcha scale is a simple 4-point observational tool used to assess pediatric emergence delirium (ED) (agitation or confusion) as children wake up from general anesthesia. It measures the severity of agitation, with scores \>2 generally indicating significant agitation or delirium.

  2 hours after surgery

• Presence of ED (in EEG and BIS groups) - FLACC scale

  The presence of emergence delirium in the EEG and BIS groups will be assessed using the FLACC scale at the recovery room. The FLACC scale (Face, Legs, Activity, Cry, Consolability) is a behavioral tool designed to measure pain in infants, young children (2 months to 7 years), and non-verbal patients. It evaluates five behaviors, scoring each from 0-2, for a total score of 0-10, where higher scores indicate greater pain.

  2 hours after surgery

Secondary Outcomes (5)

• Safety of EEG and BIS monitoring in relation to ED - heart rate

  During general anaesthesia, up to 2 hours

• Safety of EEG and BIS monitoring in relation to ED - blood pressure

  During general anaesthesia, up to 2 hours

• Safety of EEG and BIS monitoring in relation to ED - patient movement

  During general anaesthesia, up to 2 hours

• Safety of EEG and BIS monitoring in relation to ED - patient sweating

  During general anaesthesia, up to 2 hours

• Safety of EEG and BIS monitoring in relation to ED - patient lacrimation

  During general anaesthesia, up to 2 hours

Study Arms (2)

EEG monitoring

EXPERIMENTAL

Study subjects randomised into this arm will undergo EEG monitoring during anaesthesia.

Diagnostic Test: EEG monitoring

BIS monitoring

EXPERIMENTAL

Study subjects randomised into this arm will undergo BIS monitoring during anaesthesia.

Diagnostic Test: BIS monitoring

Interventions

EEG monitoring DIAGNOSTIC_TEST

EEG monitoring will be performed during anaesthesia.

EEG monitoring

BIS monitoring DIAGNOSTIC_TEST

BIS monitoring will be performed during anaesthesia.

BIS monitoring

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Neurological disease, severe hearing and vision impairment
• Health status corresponding to ASA (American Society of Anesthesiologists) III and above

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Vilém Novák, MD, Ph.D.

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

+42059737; jiri.hyncica@fno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be used in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study subjects will be randomised into two study groups.

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)