Anesthesia
Conditions
Keywords
Depth of anesthesia
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.
Interventions
None listed
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 8 Years
Healthy volunteers
No
Inclusion criteria
Study Group. Inclusion Criteria: * male or female children 0,5 to 8 years * planned elective surgery * informed consent by both parents, if both parents have joint custody
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | During the operation | This Monitoring of heart rate will be measured at the defined EEG measurement timepoints from STARTAnesth to EXE. |
| Blood pressure | During the operation | This Monitoring of the blood pressure will be measured at the defined EEG measurement timepoints from STARTAnesth to EXE. |
| Body temperature | During the operation | This Monitoring of body temperature will be measured at the defined EEG measurement timepoints from STARTAnesth to EXE. |
| 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 | — |
| 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 \[Dill et al. 2016\] |
| Type of surgery | During the operation | — |
| Specific field of surgery | During the operation | — |
| Duration of surgery | During the operation | — |
| 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 |
| 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) |
| 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) \[Sikich et al. 2004; Locatelli et al. 2013\] |
| Lactate | Up to 5 postoperative days | Laboratory parameter |
| Hemoglobin | Up to 5 postoperative days | Laboratory parameter |
| Soluble Interleukin - 6 | Up to the end of the operation | Laboratory parameter |
| Analgesia | Up to the end of stay in the recovery room, an expected average of 1 hour | — |
| Hypnotics | Begin of Anesthesia up to the end of stay in the recovery room, an expected average of 1 hour | — |
| 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. |
| 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 |
| Burst suppression ratio | During the operation | Measured by Narcotrend monitor |
| 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) |
| 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 FLACC- Scale |
| 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 |
| C-reactive protein | Up to 5 postoperative days | — |
| Carbon dioxide (CO2) and oxygen (O2) monitoring | During the operation | — |
| Positive endexpiratory pressure | During the operation | — |
| Inspiratory pressure | During the operation | — |
| Tidal volume breathing frequency | During the operation | — |
| Minute volume | During the operation | — |
| Anxiety of the children | Up to 365 postoperative days | Observation of anxiety during psychological assessment on a 4-point-Likert-scale |
| Anxiety of the parents | Up to 365 postoperative days | Baseline (STAI) after 3 months (STAI) |
| Compliance of the children | At the beginning of the operation | Measured by Induction compliance checklist |
| Stress | Up to 365 postoperative days | Stress is measured of of parents and of children. Parenting stress index (PSI) (German version: Eltern-Belastungsinventar (EBI)) |
| Glucose | Up to 5 postoperative days | — |
| 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 | — |
| Postoperative organ complications | 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 children | At the beginning of the operation | mYale-SF (2-8 years) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Medical history | At the beginning of the investigation | — |
| Previous number of surgeries | At the beginning of the investigation | — |
| Previous medication | At the beginning of the investigation | — |
| Main diagnosis | At the beginning of the investigation | he diagnosis that is responsible for occasioning the performance of inpatient treatment. |
| Demographic and background data | At the beginning of the investigation | Demographic and background data are collected by gender, ethnicity, education of the parents, language, number of siblings, family Situation) |
| Age | At the beginning of the investigation | Age will be measured in months and in years |
| ASA classification | At the beginning of the investigation | — |
Countries
Germany
Outcome results
None listed