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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02481999
Other study ID # Narco-Kids
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 8, 2015
Est. completion date May 24, 2017

Study information

Verified date August 2018
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Terminated
Enrollment 168
Est. completion date May 24, 2017
Est. primary completion date February 22, 2017
Accepts healthy volunteers No
Gender All
Age group 6 Months to 8 Years
Eligibility 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

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


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - University Medicine Berlin Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Age Age will be measured in months and in years At the beginning of the investigation
Other ASA classification At the beginning of the investigation
Other Medical history At the beginning of the investigation
Other Previous number of surgeries At the beginning of the investigation
Other Previous medication At the beginning of the investigation
Other Main diagnosis he diagnosis that is responsible for occasioning the performance of inpatient treatment. At the beginning of the investigation
Other Demographic and background data Demographic and background data are collected by gender, ethnicity, education of the parents, language, number of siblings, family Situation) At the beginning of the investigation
Primary 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) Until discharge of the child from the recovery room, an expected average of 1 hour
Secondary 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 During the operation
Secondary Incidence of behavioral problem The behavioral problem is measured by a modified Version of the Posthospital Behavior Questionnaire" (PHBQ) (Buehrer et al. 2014) Up to 5 postoperative days
Secondary Severity of emergence Delirium The Delirium is measured by Pediatric Anesthesia Emergence Delirium Scores (PAED Score) (Sikich et al. 2004; Locatelli et al. 2013) Until discharge of the child from the recovery room, an expected average of 1 hour
Secondary Duration of emergence Delirium The Delirium is measured by Pediatric Anesthesia Emergence Delirium Scores (PAED Score)" [Sikich et al. 2004; Locatelli et al. 2013] Until discharge of the child from the recovery room, an expected average of 1 hour
Secondary Lactate Laboratory parameter Up to 5 postoperative days
Secondary Hemoglobin Laboratory parameter Up to 5 postoperative days
Secondary Soluble Interleukin - 6 Laboratory parameter Up to the end of the operation
Secondary Analgesia Up to the end of stay in the recovery room, an expected average of 1 hour
Secondary Hypnotics Begin of Anesthesia up to the end of stay in the recovery room, an expected average of 1 hour
Secondary Stress reducing agents Up to the end of stay in the recovery room, an expected average of 1 hour
Secondary Psychoactive drugs/Benzodiazepines From 1h before surgery start up to the end of stay in the operation (an expected average of 2 hours)
Secondary Fluid and transfusion therapy The fluid and transfusion therapy is measured by preoperative sobriety times by intraoperative fluid and volume administration and balance. From one day before surgery start up to the end of stay in the recovery room (an expected average of 2 hours
Secondary 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). Up to 365 postoperative days
Secondary 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)). Up to 365 postoperative days
Secondary Duration of anesthesia Measured by Narcotrend monitor During the operation
Secondary Burst suppression ratio Measured by Narcotrend monitor During the operation
Secondary Duration of surgery During the operation
Secondary 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) During the operation
Secondary Pain in children < 4 years Pain is measured by the FLACC- Scale Up to the end of stay in the recovery room, an expected average of 1 hour
Secondary Pain in children < 4 years Pain is measured by the KUSS-Score Up to the end of stay in the recovery room, an expected average of 1 hour
Secondary Pain in children = 4 years Pain is measured by the Faces Pain Scale - revised Up to the end of stay in the recovery room, an expected average of 1 hour
Secondary C-reactive protein Up to 5 postoperative days
Secondary Carbon dioxide (CO2) and oxygen (O2) monitoring During the operation
Secondary Positive endexpiratory pressure During the operation
Secondary Inspiratory pressure During the operation
Secondary Tidal volume breathing frequency During the operation
Secondary Minute volume During the operation
Secondary Anxiety of the children Observation of anxiety during psychological assessment on a 4-point-Likert-scale Up to 365 postoperative days
Secondary Anxiety of the parents Baseline (STAI) after 3 months (STAI) Up to 365 postoperative days
Secondary Compliance of the children Measured by Induction compliance checklist At the beginning of the operation
Secondary Stress Stress is measured of of parents and of children. Parenting stress index (PSI) (German version: Eltern-Belastungsinventar (EBI)) Up to 365 postoperative days
Secondary Glucose Up to 5 postoperative days
Secondary Intensive care unit length of stay Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day
Secondary Hospital length of stay Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary Postoperative organ complications Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary Behavioral changes of the children Post Hospitalization Behavior Questionnaire (PHBQ) Up to 5 postoperative days
Secondary Anxiety of children mYale-SF (2-8 years) At the beginning of the operation
Secondary Blood pressure This Monitoring of the blood pressure will be measured at the defined EEG measurement timepoints from STARTAnesth to EXE. During the operation
Secondary Body temperature This Monitoring of body temperature will be measured at the defined EEG measurement timepoints from STARTAnesth to EXE. During the operation
Secondary Heart rate This Monitoring of heart rate will be measured at the defined EEG measurement timepoints from STARTAnesth to EXE. During the operation
Secondary 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. Up to the end of stay in the recovery room, an expected average of 1 hour
Secondary Blood gas analysis Up to the end of stay in the recovery room, an expected average of 1 hour
Secondary Incidence of Delirium Incidence of Delirium is measured with the CAPD-Score [Dill et al. 2016] Up to the end of stay in the recovery room, an expected average of 1 hour
Secondary Type of surgery During the operation
Secondary Specific field of surgery During the operation
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