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This study investigates whether general anesthesia using a Pharmacokinetic/Pharmacodynamic (PK/PD) -model-based index indicating the compound effect of different anesthetics leads to optimized outcome compared to manually controlled clinical anesthesia and computerized Electroencephalogram (EEG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SmartPilot® system | 50 patients scheduled for elective surgery (general/abdominal surgery; traumatological/orthopedic surgery, gynecology, urology) in general anesthesia using the SmartPilot® system | ||
| Standard arm | 50 patients scheduled for elective surgery (general/abdominal surgery; traumatological/orthopedic surgery, gynecology, urology) in general anesthesia according to the standard operating procedures of the department, i.e. manually controlled clinical anesthesia and EEG-derived parameters of anesthetic depth |
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| Measure | Description | Time Frame |
|---|---|---|
| Postoperative delirium | Nursing Delirium Csreening Scale (Nu-DESC), Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-R), International Classification of Diseases (ICD-10) | In the 8-day postoperative sample period |
| Postoperative cognitive deficit | Test Battery: Verbal Learning Test, Stroop Colour Word Test, Letter Digit Substitution Test, Concept Shifting Test | In the 8-day postoperative sample period |
| Measure | Description | Time Frame |
|---|---|---|
| Wake-up time | In the 8-day postoperative sample period | |
| Duration of treatment in the recovery room | In the 8-day postoperative sample period | |
| Correlation of EEG-based depth of anesthesia (BIS®) with PK/PD-based Noxious Stimulus Response Index (NSRI) of the SmartPilot® system. |
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Inclusion Criteria:
Exclusion Criteria:
Due to the underlying PKPD models of the SmartPilot® system, patient with the following characteristics cannot be anesthetized using SmartPilot®:
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Male/female patients scheduled for elective surgery (general/abdominal surgery; traumatological/orthopedic surgery, gynecology, urology) in general anesthesia at Charité - Universitaetsmedizin Berlin, Campus Mitte and Campus Virchow-Klinikum
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| Name | Affiliation | Role |
|---|---|---|
| Spies Claudia, MD, Prof. | Charite University, Berlin, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitätsmedizin | Berlin | 13353 | Germany |
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| In the 8-day postoperative sample period |
| Correlation of Bispectral index (BIS®)- and NSRI readings with Near infrared spectroscopy (NIRS) - readings as parameters of regional cerebral oxygen saturation. | In the 8-day postoperative sample period |