NCT02481999

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 168 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 6 Months – 8 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia

Timeline

• Start date: 2015-09-08
• Primary completion: 2017-02-22
• Completion: 2017-05-24
• First posted: 2015-06-25
• Last updated: 2018-08-20

Locations

1 site across 1 country: Germany