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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-08

Study Completion Date

2017-05-24

Brief Summary

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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.

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Detailed Description

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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

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Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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

* 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

* 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:

* 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

Minimum Eligible Age

6 Months

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No