Evaluation of mechanisms and factors of anaesthesia on postoperative delirium and emergence agitation as well as on postoperative cognitive function in children aged 0,5-8 years scheduled for elective surgery. The depth of anesthesia in children for elective surgery aged 0,5-6 years is monitored with intraoperative "Narcotrend-Compact-M-Monitoring". Postoperatively the "Pediatric Anesthesia Emergence Delirium Scores (PAED Score)" \[Sikich et al. 2004;Locatelli et al. 2013\] is used to screen for the frequency of postoperative delirium in the post anesthesia care unit discharge of the child after surgery. Cognitive testings are performed in children of the study group (n= 470) and a control group (n= 80) with the parents support to evaluate deficits in children in their cognitive areas (POCD (Postoperative cognitive deficit)) at three different time points up to three months.
According to recent studies in children aged from 0,5 to 8 years "Narcotrend Monitor" (from EEG derived monitoring of the frontal brain waves) can reliably measure the depth of anesthesia \[Münte et al. 2009; Weber et al. 2005\]. Depth of anesthesia in adults is significantly correlated with the incidence of postoperative delirium and longer lasting cognitive deficits \[Radtke et al. 2013; Chan et al. 2013; Whitlock et al. 2014\]. We know from animal experimental studies that anesthetics have a potential toxic effect in the developing brain. \[Sinner et al 2014\]. After two years (approximately 1/3 - 1/2 of the total sample) an interim analysis with recalculation of the case numbers is carried out, if the initial effect sizes differ strongly.
Study Type
OBSERVATIONAL
Enrollment
168
Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - University Medicine Berlin
Berlin, Germany
Incidence of emergence delirium and postoperative delirium
The Delirium is measured by the Pediatric Anesthesia Emergence Delirium Scores (PAED Score) (Sikich et al. 2004; Locatelli et al. 2013)
Time frame: Until discharge of the child from the recovery room, an expected average of 1 hour
Depth of anesthesia
Depth of anesthesia assessed by band-power of the 4 frequency bands (alpha, beta, theta, delta) and activity in percentages of total spectral power ( F50% / F95%) assessed with Narcotrend Monitor
Time frame: During the operation
Incidence of behavioral problem
The behavioral problem is measured by a modified Version of the Posthospital Behavior Questionnaire" (PHBQ) (Buehrer et al. 2014)
Time frame: Up to 5 postoperative days
Severity of emergence Delirium
The Delirium is measured by Pediatric Anesthesia Emergence Delirium Scores (PAED Score) (Sikich et al. 2004; Locatelli et al. 2013)
Time frame: Until discharge of the child from the recovery room, an expected average of 1 hour
Duration of emergence Delirium
The Delirium is measured by Pediatric Anesthesia Emergence Delirium Scores (PAED Score)" \[Sikich et al. 2004; Locatelli et al. 2013\]
Time frame: Until discharge of the child from the recovery room, an expected average of 1 hour
Lactate
Laboratory parameter
Time frame: Up to 5 postoperative days
Hemoglobin
Laboratory parameter
Time frame: Up to 5 postoperative days
Soluble Interleukin - 6
Laboratory parameter
Time frame: Up to the end of the operation
Analgesia
Time frame: Up to the end of stay in the recovery room, an expected average of 1 hour
Hypnotics
Time frame: Begin of Anesthesia up to the end of stay in the recovery room, an expected average of 1 hour
Stress reducing agents
Time frame: Up to the end of stay in the recovery room, an expected average of 1 hour
Psychoactive drugs/Benzodiazepines
Time frame: From 1h before surgery start up to the end of stay in the operation (an expected average of 2 hours)
Fluid and transfusion therapy
The fluid and transfusion therapy is measured by preoperative sobriety times by intraoperative fluid and volume administration and balance.
Time frame: From one day before surgery start up to the end of stay in the recovery room (an expected average of 2 hours
Postoperative cognitive deficit (POCD) in children 6 to 42 months
POCD is measured by parent questionnaires (BRIEF-P) and in children by the Bayley III Scales of Infant and Toddler Development (cognitive, language, motor function and processing speed, social emotional scale) and NEPSY II (Statue, word generation, Visuomotor precision from 3 years).
Time frame: Up to 365 postoperative days
Postoperative cognitive deficit (POCD) in children 43 to 96 months
POCD is measured by parent questionnaires (BRIEF-P, BRIEF) and in children by the Colored Progressive Matrices (CPM), the CANTAB test battery and NEPSY-II subtests (Visuomotor precision, word generation, statue (until 6 years); animal sorting (from 7 years)).
Time frame: Up to 365 postoperative days
Duration of anesthesia
Measured by Narcotrend monitor
Time frame: During the operation
Burst suppression ratio
Measured by Narcotrend monitor
Time frame: During the operation
Duration of surgery
Time frame: During the operation
Time schedule for intraoperative EEG recording
Predefined time points: Baseline, start of anesthetic administration (STARTAnesth), start of analgesic administration (STARTAnalg), Loss of consciousness (LOC), airway device insertion \[INT\], skin incision/ surgery start (SKIN), intraoperative steady state (OP), stop of anesthetic administration (ENDAnesth), stop of analgesic administration (ENDAnalg),airway device removal \[EXE\] regain of consciousness (ROC), awakening (AWK)
Time frame: During the operation
Pain in children < 4 years
Pain is measured by the FLACC- Scale
Time frame: Up to the end of stay in the recovery room, an expected average of 1 hour
Pain in children < 4 years
Pain is measured by the KUSS-Score
Time frame: Up to the end of stay in the recovery room, an expected average of 1 hour
Pain in children ≥ 4 years
Pain is measured by the Faces Pain Scale - revised
Time frame: Up to the end of stay in the recovery room, an expected average of 1 hour
C-reactive protein
Time frame: Up to 5 postoperative days
Carbon dioxide (CO2) and oxygen (O2) monitoring
Time frame: During the operation
Positive endexpiratory pressure
Time frame: During the operation
Inspiratory pressure
Time frame: During the operation
Tidal volume breathing frequency
Time frame: During the operation
Minute volume
Time frame: During the operation
Anxiety of the children
Observation of anxiety during psychological assessment on a 4-point-Likert-scale
Time frame: Up to 365 postoperative days
Anxiety of the parents
Baseline (STAI) after 3 months (STAI)
Time frame: Up to 365 postoperative days
Compliance of the children
Measured by Induction compliance checklist
Time frame: At the beginning of the operation
Stress
Stress is measured of of parents and of children. Parenting stress index (PSI) (German version: Eltern-Belastungsinventar (EBI))
Time frame: Up to 365 postoperative days
Glucose
Time frame: Up to 5 postoperative days
Intensive care unit length of stay
Time frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day
Hospital length of stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Postoperative organ complications
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Behavioral changes of the children
Post Hospitalization Behavior Questionnaire (PHBQ)
Time frame: Up to 5 postoperative days
Anxiety of children
mYale-SF (2-8 years)
Time frame: At the beginning of the operation
Blood pressure
This Monitoring of the blood pressure will be measured at the defined EEG measurement timepoints from STARTAnesth to EXE.
Time frame: During the operation
Body temperature
This Monitoring of body temperature will be measured at the defined EEG measurement timepoints from STARTAnesth to EXE.
Time frame: During the operation
Heart rate
This Monitoring of heart rate will be measured at the defined EEG measurement timepoints from STARTAnesth to EXE.
Time frame: During the operation
Clinical routine anesthesia parameters
Clinical routine anesthesia parameters are measured by primary induction technique, type of induction, type of maintenance of anesthesia, airway management, additional regional anesthesia, type of regional anesthesia, time of regional anesthesia, application during operation and blood gas analysis) during anesthesia until end of recovery room stay.
Time frame: Up to the end of stay in the recovery room, an expected average of 1 hour
Blood gas analysis
Time frame: Up to the end of stay in the recovery room, an expected average of 1 hour
Incidence of Delirium
Incidence of Delirium is measured with the CAPD-Score \[Dill et al. 2016\]
Time frame: Up to the end of stay in the recovery room, an expected average of 1 hour
Type of surgery
Time frame: During the operation
Specific field of surgery
Time frame: During the operation
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