An interventional study of EEG monitoring and BIS monitoring in Emergence Delirium, Anesthesia, sponsored by University Hospital Ostrava. Recruiting at 1 site in Czechia. Open to participants aged 1 Year to 6 Years. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by University Hospital Ostrava · Not applicable, Interventional, and Treatment
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.
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.
751 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.
This study's planned enrollment of 540 is above the median of 120 across 464 interventional studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →University Hospital Ostrava is the lead sponsor of 148 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study subjects randomised into this arm will undergo EEG monitoring during anaesthesia.
Diagnostic Test: EEG monitoring
Study subjects randomised into this arm will undergo BIS monitoring during anaesthesia.
Diagnostic Test: BIS monitoring
EEG monitoring will be performed during anaesthesia.
BIS monitoring will be performed during anaesthesia.
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).
Time frame: 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.
Time frame: 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.
Time frame: 2 hours after surgery
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: During general anaesthesia, up to 2 hours
Plan to share: No — There is no plan to share individual participant data with other researchers. The data may be provided upon reasonable request.
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