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Completed

NCT Number: NCT01694901

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

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Key information

Conditions

Postoperative Cognitive Disturbances

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Postoperative delirium

    Time frame: 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)

  2. Postoperative cognitive deficit

    Time frame: In the 8-day postoperative sample period

    Test Battery: Verbal Learning Test, Stroop Colour Word Test, Letter Digit Substitution Test, Concept Shifting Test

Secondary outcomes

  1. Wake-up time

    Time frame: In the 8-day postoperative sample period

  2. Duration of treatment in the recovery room

    Time frame: In the 8-day postoperative sample period

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Claudia Spies

Other

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Sep 27, 2012
Registry last updated
Jun 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.