NCT Number: NCT07534215
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.
Interested in participating?
Request Info1 year–6 year
All sexes
Interventional
Not applicable
Ostrava, Moravian-Silesian Region, 708 52, Czechia
Location status: Recruiting
Eva Štěpánová, MD, Ph.D.
SUB_INVESTIGATOR
Jiří Hynčica
CONTACT
+42059737 ext. 2587
Michal Frelich, MD, Ph.D.
SUB_INVESTIGATOR
Tereza Otipková, MD
SUB_INVESTIGATOR
Vilém Novák, MD, Ph.D.
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
EEG monitoring will be performed during anaesthesia.
BIS monitoring will be performed during anaesthesia.
Time frame: 2 hours after surgery
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
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
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: During general anaesthesia, up to 2 hours
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
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
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
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
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).
Contact information is provided by the study sponsor or research team.
University Hospital Ostrava
Other
Comparison of the Effect of EEG and BIS-guided Anaesthesia on the Incidence of Emergent Delirium in Children: a Prospective Monocentric Study
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