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

Completed

• Conditions: Postoperative Cognitive Disturbances

• Registration Number: NCT01694901
• Lead Sponsor: Claudia Spies

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-09-25
• Study First Posted: 2012-09-27
• Study Start: 2013-11-12
• Primary Completion: 2016-03-01
• Study Completion: 2017-07-14
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-27
• Last Update Posted: 2019-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative delirium	In the 8-day postoperative sample period	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)
Postoperative cognitive deficit	In the 8-day postoperative sample period	Test Battery: Verbal Learning Test, Stroop Colour Word Test, Letter Digit Substitution Test, Concept Shifting Test

Secondary Outcome Measures

Name	Time	Method
Wake-up time	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
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

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitätsmedizin; 🇩🇪 Berlin, Germany