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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01694901

Enrollment

150

Registered

2012-09-27

Start date

2013-11-12

Completion date

2017-07-14

Last updated

2019-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Cognitive Disturbances

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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

Countries

Germany

Outcome results