AnesthesiaNCT02481999
Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
An observational study of Anesthesia, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 6 months to 8 years
- Conditions the study is for
- Anesthesia
- How many people
- 168 participants
- Where
- 1 siteGermany
- Study dates
- 8 Sep 2015to 24 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Children for elective surgery aged from 0, 5 to 8 years
Who may be able to join
- male or female children 0,5 to 8 years
- planned elective surgery
- informed consent by both parents, if both parents have joint custody
- 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
Who cannot join
- 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
Show all 12Show fewer
- Control Group:
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - University Medicine Berlin
Berlin, 13353
About this study
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.
Read the 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.
- Conditions
- Anesthesia
- Keywords
- Depth of anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group: Patients | 470 children for elective surgery 0,5 to 8 years Analysis of EEG data will divided in four age-related groups because of the different baseline EEG activity: * 0.5 - 12 month: 5-7 Hz activity / blocked by eye opening * 12 - 36 month: 7-8 Hz activity / Variability 5 - 10 Hz * 3 - 6 years: 8 Hz activity / amplitude 100µV * 6 - 8 years 10Hz activity / amplitude 100 µV | |
| Control group: Healthy children for POCD assessment | 80 healthy children (siblings of study group children and children from Kindergarten) 0,5 to 8 years with no operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Until discharge of the child from the recovery room, an expected average of 1 hour
Secondary outcomes (45)
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
Measured: 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)
Measured: 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)
Measured: 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]
Measured: Until discharge of the child from the recovery room, an expected average of 1 hour
Lactate
Laboratory parameter
Measured: Up to 5 postoperative days
Hemoglobin
Laboratory parameter
Measured: Up to 5 postoperative days
Soluble Interleukin - 6
Laboratory parameter
Measured: Up to the end of the operation
Analgesia
Measured: Up to the end of stay in the recovery room, an expected average of 1 hour
Hypnotics
Measured: Begin of Anesthesia up to the end of stay in the recovery room, an expected average of 1 hour
Stress reducing agents
Measured: Up to the end of stay in the recovery room, an expected average of 1 hour
Psychoactive drugs/Benzodiazepines
Measured: 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.
Measured: 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).
Measured: 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)).
Measured: Up to 365 postoperative days
Duration of anesthesia
Measured by Narcotrend monitor
Measured: During the operation
Burst suppression ratio
Measured by Narcotrend monitor
Measured: During the operation
Duration of surgery
Measured: 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)
Measured: During the operation
Pain in children < 4 years
Pain is measured by the FLACC- Scale
Measured: 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
Measured: 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
Measured: Up to the end of stay in the recovery room, an expected average of 1 hour
C-reactive protein
Measured: Up to 5 postoperative days
Carbon dioxide (CO2) and oxygen (O2) monitoring
Measured: During the operation
Positive endexpiratory pressure
Measured: During the operation
Inspiratory pressure
Measured: During the operation
Tidal volume breathing frequency
Measured: During the operation
Minute volume
Measured: During the operation
Anxiety of the children
Observation of anxiety during psychological assessment on a 4-point-Likert-scale
Measured: Up to 365 postoperative days
Anxiety of the parents
Baseline (STAI) after 3 months (STAI)
Measured: Up to 365 postoperative days
Compliance of the children
Measured by Induction compliance checklist
Measured: 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))
Measured: Up to 365 postoperative days
Glucose
Measured: Up to 5 postoperative days
Intensive care unit length of stay
Measured: Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day
Hospital length of stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Postoperative organ complications
Measured: 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)
Measured: Up to 5 postoperative days
Anxiety of children
mYale-SF (2-8 years)
Measured: 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.
Measured: During the operation
Body temperature
This Monitoring of body temperature will be measured at the defined EEG measurement timepoints from STARTAnesth to EXE.
Measured: During the operation
Heart rate
This Monitoring of heart rate will be measured at the defined EEG measurement timepoints from STARTAnesth to EXE.
Measured: 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.
Measured: Up to the end of stay in the recovery room, an expected average of 1 hour
Blood gas analysis
Measured: 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]
Measured: Up to the end of stay in the recovery room, an expected average of 1 hour
Type of surgery
Measured: During the operation
Specific field of surgery
Measured: During the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study start8 Sep 2015
- Primary completion22 Feb 2017
- Study completion24 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481999
- Sponsor's protocol ID
- Narco-Kids
- Status last verified
- Aug 2018
- First submitted
- 23 Jun 2015
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Markus M, Panagiotou F, Spies C, Koch S. EEG Dynamics in Children Before, During and After General Anesthesia. Paediatr Anaesth. 2026 Jun;36(6):641-649. doi: 10.1002/pan.70156. Epub 2026 Mar 5.
PubMed 41787671Koch S, Stegherr AM, Rupp L, Kruppa J, Prager C, Kramer S, Fahlenkamp A, Spies C. Emergence delirium in children is not related to intraoperative burst suppression - prospective, observational electrography study. BMC Anesthesiol. 2019 Aug 8;19(1):146. doi: 10.1186/s12871-019-0819-2.
PubMed 31395011Koch S, Rupp L, Prager C, Wernecke KD, Kramer S, Fahlenkamp A, Spies CD. Emergence delirium in children is related to epileptiform discharges during anaesthesia induction: An observational study. Eur J Anaesthesiol. 2018 Dec;35(12):929-936. doi: 10.1097/EJA.0000000000000867.
PubMed 30113351Koch S, Rupp L, Prager C, Morgeli R, Kramer S, Wernecke KD, Fahlenkamp A, Spies C. Incidence of epileptiform discharges in children during induction of anaesthesia using Propofol versus Sevoflurane. Clin Neurophysiol. 2018 Aug;129(8):1642-1648. doi: 10.1016/j.clinph.2018.05.013. Epub 2018 Jun 8.
PubMed 29913339
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
- ClinicalTrials.gov ID
- NCT02481999
- Acronym / sponsor ID
- Narco-Kids
- Conditions
- Anesthesia
- Keywords
- Depth of anesthesia
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 8 Sep 2015 (actual)
- Primary completion
- 22 Feb 2017 (actual)
- Study completion
- 24 May 2017 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group: Patients | – | –470 children for elective surgery 0,5 to 8 years Analysis of EEG data will divided in four age-related groups because of the different baseline EEG activity: * 0.5 - 12 month: 5-7 Hz activity / blocked by eye opening * 12 - 36 month: 7-8 Hz activity / Variability 5 - 10 Hz * 3 - 6 years: 8 Hz activity / amplitude 100µV * 6 - 8 years 10Hz activity / amplitude 100 µV |
| Control group: Healthy children for POCD assessment | – | –80 healthy children (siblings of study group children and children from Kindergarten) 0,5 to 8 years with no operation |
Who may qualify
- Ages
- 6 months to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children for elective surgery aged from 0, 5 to 8 years
Key inclusion criteria (7 listed)
- male or female children 0,5 to 8 years
- planned elective surgery
- informed consent by both parents, if both parents have joint custody
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of emergence delirium and postoperative delirium
Time frame: 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)
45 secondary outcomes
Depth of anesthesia
Time frame: During the operation
Incidence of behavioral problem
Time frame: Up to 5 postoperative days
Severity of emergence Delirium
Time frame: Until discharge of the child from the recovery room, an expected average of 1 hour
Duration of emergence Delirium
Time frame: Until discharge of the child from the recovery room, an expected average of 1 hour
Lactate
Time frame: Up to 5 postoperative days
Hemoglobin
Time frame: Up to 5 postoperative days
Soluble Interleukin - 6
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
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
Time frame: Up to 365 postoperative days
Postoperative cognitive deficit (POCD) in children 43 to 96 months
Time frame: Up to 365 postoperative days
Duration of anesthesia
Time frame: During the operation
Burst suppression ratio
Time frame: During the operation
Duration of surgery
Time frame: During the operation
Time schedule for intraoperative EEG recording
Time frame: During the operation
Pain in children < 4 years
Time frame: Up to the end of stay in the recovery room, an expected average of 1 hour
Pain in children < 4 years
Time frame: Up to the end of stay in the recovery room, an expected average of 1 hour
Pain in children ≥ 4 years
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
Time frame: Up to 365 postoperative days
Anxiety of the parents
Time frame: Up to 365 postoperative days
Compliance of the children
Time frame: At the beginning of the operation
Stress
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
Time frame: Up to 5 postoperative days
Anxiety of children
Time frame: At the beginning of the operation
Blood pressure
Time frame: During the operation
Body temperature
Time frame: During the operation
Heart rate
Time frame: During the operation
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Derived from this study: PubMed 41787671Markus M, Panagiotou F, Spies C, Koch S. EEG Dynamics in Children Before, During and After General Anesthesia. Paediatr Anaesth. 2026 Jun;36(6):641-649. doi: 10.1002/pan.70156. Epub 2026 Mar 5.
- Derived from this study: PubMed 31395011Koch S, Stegherr AM, Rupp L, Kruppa J, Prager C, Kramer S, Fahlenkamp A, Spies C. Emergence delirium in children is not related to intraoperative burst suppression - prospective, observational electrography study. BMC Anesthesiol. 2019 Aug 8;19(1):146. doi: 10.1186/s12871-019-0819-2.
- Derived from this study: PubMed 30113351Koch S, Rupp L, Prager C, Wernecke KD, Kramer S, Fahlenkamp A, Spies CD. Emergence delirium in children is related to epileptiform discharges during anaesthesia induction: An observational study. Eur J Anaesthesiol. 2018 Dec;35(12):929-936. doi: 10.1097/EJA.0000000000000867.
- Derived from this study: PubMed 29913339Koch S, Rupp L, Prager C, Morgeli R, Kramer S, Wernecke KD, Fahlenkamp A, Spies C. Incidence of epileptiform discharges in children during induction of anaesthesia using Propofol versus Sevoflurane. Clin Neurophysiol. 2018 Aug;129(8):1642-1648. doi: 10.1016/j.clinph.2018.05.013. Epub 2018 Jun 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of emergence delirium and postoperative delirium (time frame: Until discharge of the child from the recovery room, an expected average of 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02481999, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.