Clinical trial NCT02481999: Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Official title: Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anesthesia
Keywords: Depth of anesthesia
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 168
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children for elective surgery aged from 0, 5 to 8 years

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.

Eligibility 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

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

Primary outcomes:
measure: Incidence of emergence delirium and postoperative delirium
timeFrame: Until discharge of the child from the recovery room, an expected average of 1 hour
Secondary outcomes:
measure: Depth of anesthesia
timeFrame: During the operation
measure: Incidence of behavioral problem
timeFrame: Up to 5 postoperative days
measure: Severity of emergence Delirium
timeFrame: Until discharge of the child from the recovery room, an expected average of 1 hour
measure: Duration of emergence Delirium
timeFrame: Until discharge of the child from the recovery room, an expected average of 1 hour
measure: Lactate
timeFrame: Up to 5 postoperative days
measure: Hemoglobin
timeFrame: Up to 5 postoperative days
measure: Soluble Interleukin - 6
timeFrame: Up to the end of the operation
measure: Analgesia
timeFrame: Up to the end of stay in the recovery room, an expected average of 1 hour
measure: Hypnotics
timeFrame: Begin of Anesthesia up to the end of stay in the recovery room, an expected average of 1 hour
measure: Stress reducing agents
timeFrame: Up to the end of stay in the recovery room, an expected average of 1 hour
measure: Psychoactive drugs/Benzodiazepines
timeFrame: From 1h before surgery start up to the end of stay in the operation (an expected average of 2 hours)
measure: Fluid and transfusion therapy
timeFrame: From one day before surgery start up to the end of stay in the recovery room (an expected average of 2 hours
measure: Postoperative cognitive deficit (POCD) in children 6 to 42 months
timeFrame: Up to 365 postoperative days
measure: Postoperative cognitive deficit (POCD) in children 43 to 96 months
timeFrame: Up to 365 postoperative days
measure: Duration of anesthesia
timeFrame: During the operation
measure: Burst suppression ratio
timeFrame: During the operation
measure: Duration of surgery
timeFrame: During the operation
measure: Time schedule for intraoperative EEG recording
timeFrame: During the operation
measure: Pain in children < 4 years
timeFrame: Up to the end of stay in the recovery room, an expected average of 1 hour
measure: Pain in children < 4 years
timeFrame: Up to the end of stay in the recovery room, an expected average of 1 hour
measure: Pain in children ≥ 4 years
timeFrame: Up to the end of stay in the recovery room, an expected average of 1 hour
measure: C-reactive protein
timeFrame: Up to 5 postoperative days
measure: Carbon dioxide (CO2) and oxygen (O2) monitoring
timeFrame: During the operation
measure: Positive endexpiratory pressure
timeFrame: During the operation
measure: Inspiratory pressure
timeFrame: During the operation
measure: Tidal volume breathing frequency
timeFrame: During the operation
measure: Minute volume
timeFrame: During the operation
measure: Anxiety of the children
timeFrame: Up to 365 postoperative days
measure: Anxiety of the parents
timeFrame: Up to 365 postoperative days
measure: Compliance of the children
timeFrame: At the beginning of the operation
measure: Stress
timeFrame: Up to 365 postoperative days
measure: Glucose
timeFrame: Up to 5 postoperative days
measure: Intensive care unit length of stay
timeFrame: Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day
measure: Hospital length of stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Postoperative organ complications
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Behavioral changes of the children
timeFrame: Up to 5 postoperative days
measure: Anxiety of children
timeFrame: At the beginning of the operation
measure: Blood pressure
timeFrame: During the operation
measure: Body temperature
timeFrame: During the operation
measure: Heart rate
timeFrame: During the operation
measure: Clinical routine anesthesia parameters
timeFrame: Up to the end of stay in the recovery room, an expected average of 1 hour
measure: Blood gas analysis
timeFrame: Up to the end of stay in the recovery room, an expected average of 1 hour
measure: Incidence of Delirium
timeFrame: Up to the end of stay in the recovery room, an expected average of 1 hour
measure: Type of surgery
timeFrame: During the operation
measure: Specific field of surgery
timeFrame: During the operation
Other outcomes:
measure: Age
timeFrame: At the beginning of the investigation
measure: ASA classification
timeFrame: At the beginning of the investigation
measure: Medical history
timeFrame: At the beginning of the investigation
measure: Previous number of surgeries
timeFrame: At the beginning of the investigation
measure: Previous medication
timeFrame: At the beginning of the investigation
measure: Main diagnosis
timeFrame: At the beginning of the investigation
measure: Demographic and background data
timeFrame: At the beginning of the investigation
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - University Medicine Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References:
citation: Koch 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.
citation: Koch 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.
citation: Koch 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.