NCT07534215

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: University Hospital Ostrava · Academic / Other
• Sex: All
• Age: 1 Year – 6 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Emergence Delirium, Anesthesia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	EEG monitoring	EEG monitoring will be performed during anaesthesia.
DIAGNOSTIC_TEST	BIS monitoring	BIS monitoring will be performed during anaesthesia.

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-10-01
• Completion: 2028-12-01
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: Czechia