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

NCT02481999 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 168

Last updated 2018-08-20

No results posted yet for this study

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.

Conditions

  • Anesthesia

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Claudia Spies, MD, Prof. · Charite University, Berlin, Germany

Eligibility

Min Age
6 Months
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-08
Primary Completion
2017-02-22
Completion
2017-05-24

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02481999 on ClinicalTrials.gov