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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorUniversity Hospital Ostrava

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • EEG monitoring

    Diagnostic test

    EEG monitoring will be performed during anaesthesia.

  • BIS monitoring

    Diagnostic test

    BIS monitoring will be performed during anaesthesia.

Treatment groups

540 Participants
are divided into 2 treatment groups
Group A: EEG monitoringExperimental treatment 1 intervention
Group B: BIS monitoringExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

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