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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01694901
First received: September 25, 2012
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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).


Condition
Postoperative Cognitive Disturbances

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Postoperative delirium [ Time Frame: In the 8-day postoperative sample period ] [ Designated as safety issue: No ]
    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 [ Time Frame: In the 8-day postoperative sample period ] [ Designated as safety issue: No ]
    Test Battery: Verbal Learning Test, Stroop Colour Word Test, Letter Digit Substitution Test, Concept Shifting Test


Secondary Outcome Measures:
  • Wake-up time [ Time Frame: In the 8-day postoperative sample period ] [ Designated as safety issue: No ]
  • Duration of treatment in the recovery room [ Time Frame: In the 8-day postoperative sample period ] [ Designated as safety issue: No ]
  • Correlation of EEG-based depth of anesthesia (BIS®) with PK/PD-based Noxious Stimulus Response Index (NSRI) of the SmartPilot® system. [ Time Frame: In the 8-day postoperative sample period ] [ Designated as safety issue: No ]
  • Correlation of Bispectral index (BIS®)- and NSRI readings with Near infrared spectroscopy (NIRS) - readings as parameters of regional cerebral oxygen saturation. [ Time Frame: In the 8-day postoperative sample period ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694901

Contacts
Contact: Claudia Spies, MD Prof. +49 30 450 551001 claudia.spies@charite.de

Locations
Germany
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitätsmedizin Recruiting
Berlin, Germany, 13353
Contact: Claudia Spies, MD, Prof.    +49 30 450 551001    claudia.spies@charite.de   
Sub-Investigator: Daniel Hadzidiakos, MD         
Principal Investigator: Claudia Spies, MD, Prof.         
Sponsors and Collaborators
Claudia Spies
Investigators
Study Director: Spies Claudia, MD, Prof. Charité - Universitätsmedizin Berlin, Germany
  More Information

No publications provided

Responsible Party: Claudia Spies, Prof. Dr. C. Claudia, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01694901     History of Changes
Other Study ID Numbers: Smart-Outcome
Study First Received: September 25, 2012
Last Updated: August 11, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 11, 2014