Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
- Conditions
- Anesthesia
- Registration Number
- NCT02481999
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 168
- male or female children 0,5 to 8 years
- planned elective surgery
- informed consent by both parents, if both parents have joint custody
- indication for isolation of patients with multi-resistant bacteria
- known neurological or psychiatric precondition (disease)
- inability of the parents to speak and or read German
- lacking willingness to save and hand out pseudonomized data within the clinical study
- contact allergy to silver or silver chloride
- participation in another prospective interventional clinical study during this study
Control Group:
Inclusion Criteria:
- male or female healthy children 0,5 to 8 years (siblings of study group and children from kindergarten)
- no planned operation in the next three month
- no operation in the last half year before study inclusion
- informed consent by both parents, if both parents have joint custody
Exclusion Criteria:
- Neurological or psychiatric precondition (disease), which limits the conduction of the neurocognitive testing
- Anacusis or Hypoacusis, which limits the conduction of the neurocognitive testing
- Taking psychotropic drugs (including sleep-inducing drug and benzodiazepine) on a regular basis and substances, which limit the conduction of the neurocognitive testing
- Inability of the parents to speak and or read the used language
- Lacking willingness to save and hand out pseudonomized data within the clinical study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of emergence delirium and postoperative delirium Until discharge of the child from the recovery room, an expected average of 1 hour The Delirium is measured by the Pediatric Anesthesia Emergence Delirium Scores (PAED Score) (Sikich et al. 2004; Locatelli et al. 2013)
- Secondary Outcome Measures
Name Time Method Body temperature During the operation This Monitoring of body temperature will be measured at the defined EEG measurement timepoints from STARTAnesth to EXE.
Depth of anesthesia During the operation 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
Duration of emergence Delirium Until discharge of the child from the recovery room, an expected average of 1 hour The Delirium is measured by Pediatric Anesthesia Emergence Delirium Scores (PAED Score)" \[Sikich et al. 2004; Locatelli et al. 2013\]
Type of surgery During the operation Incidence of behavioral problem Up to 5 postoperative days The behavioral problem is measured by a modified Version of the Posthospital Behavior Questionnaire" (PHBQ) (Buehrer et al. 2014)
Severity of emergence Delirium Until discharge of the child from the recovery room, an expected average of 1 hour The Delirium is measured by Pediatric Anesthesia Emergence Delirium Scores (PAED Score) (Sikich et al. 2004; Locatelli et al. 2013)
Stress reducing agents Up to the end of stay in the recovery room, an expected average of 1 hour Psychoactive drugs/Benzodiazepines From 1h before surgery start up to the end of stay in the operation (an expected average of 2 hours) Fluid and transfusion therapy From one day before surgery start up to the end of stay in the recovery room (an expected average of 2 hours The fluid and transfusion therapy is measured by preoperative sobriety times by intraoperative fluid and volume administration and balance.
Carbon dioxide (CO2) and oxygen (O2) monitoring During the operation Compliance of the children At the beginning of the operation Measured by Induction compliance checklist
Clinical routine anesthesia parameters Up to the end of stay in the recovery room, an expected average of 1 hour 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.
Blood gas analysis Up to the end of stay in the recovery room, an expected average of 1 hour Specific field of surgery During the operation Lactate Up to 5 postoperative days Laboratory parameter
Soluble Interleukin - 6 Up to the end of the operation Laboratory parameter
Hypnotics Begin of Anesthesia up to the end of stay in the recovery room, an expected average of 1 hour Burst suppression ratio During the operation Measured by Narcotrend monitor
Duration of surgery During the operation Time schedule for intraoperative EEG recording During the operation 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)
C-reactive protein Up to 5 postoperative days Positive endexpiratory pressure During the operation Tidal volume breathing frequency During the operation Analgesia Up to the end of stay in the recovery room, an expected average of 1 hour Postoperative cognitive deficit (POCD) in children 6 to 42 months Up to 365 postoperative days 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).
Postoperative cognitive deficit (POCD) in children 43 to 96 months Up to 365 postoperative days 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)).
Duration of anesthesia During the operation Measured by Narcotrend monitor
Pain in children ≥ 4 years Up to the end of stay in the recovery room, an expected average of 1 hour Pain is measured by the Faces Pain Scale - revised
Stress Up to 365 postoperative days Stress is measured of of parents and of children. Parenting stress index (PSI) (German version: Eltern-Belastungsinventar (EBI))
Pain in children < 4 years Up to the end of stay in the recovery room, an expected average of 1 hour Pain is measured by the KUSS-Score
Inspiratory pressure During the operation Anxiety of the parents Up to 365 postoperative days Baseline (STAI) after 3 months (STAI)
Intensive care unit length of stay Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day Hospital length of stay Participants will be followed for the duration of hospital stay, an expected average of 7 days Behavioral changes of the children Up to 5 postoperative days Post Hospitalization Behavior Questionnaire (PHBQ)
Anxiety of the children Up to 365 postoperative days Observation of anxiety during psychological assessment on a 4-point-Likert-scale
Postoperative organ complications Participants will be followed for the duration of hospital stay, an expected average of 7 days Anxiety of children At the beginning of the operation mYale-SF (2-8 years)
Blood pressure During the operation This Monitoring of the blood pressure will be measured at the defined EEG measurement timepoints from STARTAnesth to EXE.
Incidence of Delirium Up to the end of stay in the recovery room, an expected average of 1 hour Incidence of Delirium is measured with the CAPD-Score \[Dill et al. 2016\]
Heart rate During the operation This Monitoring of heart rate will be measured at the defined EEG measurement timepoints from STARTAnesth to EXE.
Hemoglobin Up to 5 postoperative days Laboratory parameter
Glucose Up to 5 postoperative days Minute volume During the operation
Trial Locations
- Locations (1)
Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - University Medicine Berlin
🇩🇪Berlin, Germany