The Effect of EEG and BIS-guided Anaesthesia on the Incidence of Emergent Delirium in Children

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

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.

Study Overview

• Status: Recruiting
• Conditions: Emergence Delirium, Anesthesia
• Intervention / Treatment: Diagnostic test: EEG monitoring; Diagnostic test: BIS monitoring

Detailed Description

Preoperative preparation and the method of administering general anaesthesia will be conducted based on a standardised protocol. Each patient included in the study will be administered sedative premedication Midazolam at a dose of 0.5mg/kg per os 45-60 minutes before the operation. During transfer to the operating room, Parental Separation Anxiety Scale (PSAS) and Modified Yale Preoperative Anxiety Scale (m-YPAS) will be evaluated to assess the level of preoperative anxiety as a risk factor for emergent delirium (ED). Inhalation induction of general anaesthesia with a flow rate of 4l/min O2:air with Fio2 0.5 to achieve sufficient depth of general anaesthesia, followed by provision of peripheral venous catheter, administration of Sufentanil at a dose of 0.2uq/kg and Paracetamol 15mg/kg. Airways will be secured preferentially by a laryngeal mask, in case of leakage or the nature of the procedure by orotracheal intubation. After ensuring the airways, the gas flow is reduced to 2.5%. Immediately in the electroencephalography (EEG) group, a trained nurse connects the EEG and initiates monitoring with titration of Sevoflurane to achieve a sufficient depth of unconsciousness, which will be assessed by an EEG specialist.

In the Bispectral Index (BIS) group, the child will be equipped with a BIS electrode and the depth of general anaesthesia will be controlled with the aim of BIS values of 40-60.

The time from the start of the connection to the start of the measurement of the depth of anaesthesia, the total duration of the operation and anaesthesia will also be recorded.

During anaesthesia, in addition to vital functions, the concentration of the anaesthetic and its consumption, signs of insufficient depth of general anaesthesia will be recorded In the recovery room, scales to determine the presence of emergent delirium will be assessed - Paediatric Anesthesia Emergence Delirium scale (PAED) and Watcha scale, as well as Face, Legs, Activity, Cry, Consolability scale (FLACC) and other parameters.

• Study Type: Interventional
• Enrollment (Estimated): 540
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiří Hynčica; Phone Number: 2587 +42059737; Email: jiri.hyncica@fno.cz

Study Locations

• Czechia
  • Moravian-Silesian Region
    • Ostrava, Moravian-Silesian Region, Czechia, 708 52
      • Recruiting
      • University Hospital Ostrava
      • Contact: Jiří Hynčica; Phone Number: 2587 +42059737; Email: jiri.hyncica@fno.cz
      • Principal Investigator: Vilém Novák, MD, Ph.D.
      • Sub-Investigator: Michal Frelich, MD, Ph.D.
      • Sub-Investigator: Eva Štěpánová, MD, Ph.D.
      • Sub-Investigator: Tereza Otipková, MD

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EEG monitoring; Study subjects randomised into this arm will undergo EEG monitoring during anaesthesia.	Diagnostic test: EEG monitoring; EEG monitoring will be performed during anaesthesia.
Experimental: BIS monitoring; Study subjects randomised into this arm will undergo BIS monitoring during anaesthesia.	Diagnostic test: BIS monitoring; BIS monitoring will be performed during anaesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of EEG and BIS monitoring in relation to ED - heart rate	The safety of EEG and BIS monitoring in relation to ED will be assessed using the monitoring of heart rate during anaesthesia and measured in beats per minute.	During general anaesthesia, up to 2 hours
Safety of EEG and BIS monitoring in relation to ED - blood pressure	The safety of EEG and BIS monitoring in relation to ED will be assessed using the monitoring of blood pressure during anaesthesia and measured in millimetres of mercury (mmHg).	During general anaesthesia, up to 2 hours
Safety of EEG and BIS monitoring in relation to ED - patient movement	The safety of EEG and BIS monitoring in relation to ED will be assessed using the monitoring of presence of patient movement during anaesthesia (Yes/No).	During general anaesthesia, up to 2 hours
Safety of EEG and BIS monitoring in relation to ED - patient sweating	The safety of EEG and BIS monitoring in relation to ED will be assessed using the monitoring of presence of patient sweating during anaesthesia (Yes/No).	During general anaesthesia, up to 2 hours
Safety of EEG and BIS monitoring in relation to ED - patient lacrimation	The safety of EEG and BIS monitoring in relation to ED will be assessed using the monitoring of presence of patient lacrimation during anaesthesia (Yes/No).	During general anaesthesia, up to 2 hours

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Investigators: Principal Investigator: Vilém Novák, MD, Ph.D., University Hospital Ostrava

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: EEG; General anaesthesia; Emergence Delirium; Bispectral Index
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium
• Other Study ID Numbers: BisEEg study; 17/RVO-FNOs/2026 (Other Grant/Funding Number: University Hospital Ostrava)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data with other researchers. The data may be provided upon reasonable request.

Drug and device information, study documents

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