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Recruiting Not applicable NCT07534215

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

No applicable phase (e.g. observational)
Conditions: Emergence Delirium, Anesthesia

Sponsor: University Hospital Ostrava

trial.available_in: БГ
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.
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.
Who can participate
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
Interventions
EEG monitoring
DIAGNOSTIC_TEST
BIS monitoring
DIAGNOSTIC_TEST
Locations 1
Czech Republic (1)
University Hospital Ostrava
Ostrava , Moravian-Silesian Region
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
1 Year
Maximum age
6 Years
Healthy volunteers
No
Start date
01.01.2026
Completion date
01.12.2028
Registry ID
NCT07534215
Source
clinicaltrials.gov
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