About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
EEG monitoring
Diagnostic testEEG monitoring will be performed during anaesthesia.
BIS monitoring
Diagnostic testBIS monitoring will be performed during anaesthesia.
Treatment groups
Trial outcomes
Primary outcomes
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).
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.
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.
Secondary outcomes
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.
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).
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).
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).
Sponsors and contacts
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