Clinical trial NCT01694901: Optimization of the Anesthetic Regimen Using the SmartPilot® System and Influence on Different Outcome Parameters - a Pilot Study.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Cognitive Disturbances
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2012-09-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).


Eligibility 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

Primary outcomes:
measure: Postoperative delirium
timeFrame: In the 8-day postoperative sample period
measure: Postoperative cognitive deficit
timeFrame: In the 8-day postoperative sample period
Secondary outcomes:
measure: Wake-up time
timeFrame: In the 8-day postoperative sample period
measure: Duration of treatment in the recovery room
timeFrame: In the 8-day postoperative sample period
measure: Correlation of EEG-based depth of anesthesia (BIS®) with PK/PD-based Noxious Stimulus Response Index (NSRI) of the SmartPilot® system.
timeFrame: In the 8-day postoperative sample period
measure: Correlation of Bispectral index (BIS®)- and NSRI readings with Near infrared spectroscopy (NIRS) - readings as parameters of regional cerebral oxygen saturation.
timeFrame: In the 8-day postoperative sample period
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitätsmedizin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Spies Claudia, MD, Prof.
role: STUDY_DIRECTOR
References: