Optimization of the Anesthetic Regimen Using the SmartPilot® System and Influence on Different Outcome Parameters - a Pilot Study.

Study Overview
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Brief Summary
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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).

Official Title
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Optimization of the Anesthetic Regimen Using the SmartPilot® System and Influence on Different Outcome Parameters - a Pilot Study. A Single- Center Prospective Randomized Controlled Pilot Study.

Conditions
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Postoperative Cognitive Disturbances

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Offered patient information and written informed consent Male/female patients with intended ratio of 1:1 patients aged greater than or equal to 60 years scheduled duration of surgery longer than or equal to 60 minutes elective surgery (general/abdominal surgery, traumatological/orthopedic surgery, gynecology, urology) in general anesthesia Exclusion Criteria: Persons without the capacity to consent Unability of German language use Lacking willingness to save and hand out data within the study Participation in another study according to the German Medicinal Products Act within 30 days before participation in the Smart-Outcome study Accommodation in an institution due to an official or judicial order (Unclear) history of alcohol or substances disabuse Member of staff of the Charité Neurological or psychiatric disease American Society of Anaesthesiologists (ASA) classification greater than or equal to class IV Moribund patients Due to the underlying PKPD models of the SmartPilot® system, patient with the following characteristics cannot be anesthetized using SmartPilot®: Height < 150 or > 200 cm, respectively Weight < 40 or > 140 kg, respectively Body Mass Index > 30 Age < 18 or > 90 years of age, respectively

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SmartPilot® system<br>50 patients scheduled for elective surgery (general/abdominal surgery; traumatological/orthopedic surgery, gynecology, urology) in general anesthesia using the SmartPilot® system | |
| Standard arm<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 |