The Effect of EEG and BIS-guided Anaesthesia on the Incidence of Emergent Delirium in Children
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EEG monitoring, BIS monitoring.
- Who it may be relevant to
- Registry conditions: Emergence Delirium, Anesthesia. Basic parameters: 1 year — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of the Effect of EEG and BIS-guided Anaesthesia on the Incidence of Emergent Delirium in Children: a Prospective Monocentric Study
Overview
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.
Interventions
- Diagnostic test EEG monitoring
EEG monitoring will be performed during anaesthesia. - Diagnostic test BIS monitoring
BIS monitoring will be performed during anaesthesia.
Primary outcome measures
- Presence of ED (in EEG and BIS groups) - PAED scale [Time frame: 2 hours after surgery]
- Presence of ED (in EEG and BIS groups) - Watcha scale [Time frame: 2 hours after surgery]
- Presence of ED (in EEG and BIS groups) - FLACC scale [Time frame: 2 hours after surgery]
Secondary outcome measures (5)
- Safety of EEG and BIS monitoring in relation to ED - heart rate [Time frame: During general anaesthesia, up to 2 hours]
- Safety of EEG and BIS monitoring in relation to ED - blood pressure [Time frame: During general anaesthesia, up to 2 hours]
- Safety of EEG and BIS monitoring in relation to ED - patient movement [Time frame: During general anaesthesia, up to 2 hours]
- Safety of EEG and BIS monitoring in relation to ED - patient sweating [Time frame: During general anaesthesia, up to 2 hours]
- Safety of EEG and BIS monitoring in relation to ED - patient lacrimation [Time frame: During general anaesthesia, up to 2 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Czechia · 1 center
- University Hospital Ostrava — Ostrava
Identifiers
NCT: NCT07534215 · BisEEg study · 17/RVO-FNOs/2026