Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years

Anesthesia Clinical Trial

Official title:

Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02481999
• Other study ID #: Narco-Kids
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Anesthesia

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