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

Claudia Spies150 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Postoperative Cognitive Disturbances

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitätsmedizin

Berlin, Germany

Outcomes

Primary Outcomes

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)