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

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.

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).

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