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

NCT01694901 | Completed

• 1 other identifier: Smart-Outcome
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Postoperative Cognitive Disturbances

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Claudia Spies: lead

Study Sites (1)

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

Berlin, 13353, Germany

Location

Study Officials

• Spies Claudia, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. C. Claudia

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: September 27, 2012
• Study Start: November 12, 2013
• Primary Completion: March 1, 2016
• Study Completion: July 14, 2017
• Last Updated: June 28, 2019

Record last verified: 2019-06

Locations

DE (1)