Anesthesia Clinical Trial
Official title:
Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
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.
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.
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