Postoperative Cognitive Disturbances Clinical Trial
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.
| Verified date | June 2019 |
| Source | Charite University, Berlin, Germany |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | July 14, 2017 |
| Est. primary completion date | March 1, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitätsmedizin | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| Claudia Spies |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | Wake-up time | In the 8-day postoperative sample period | ||
| Secondary | Duration of treatment in the recovery room | In the 8-day postoperative sample period | ||
| Secondary | 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 | ||
| Secondary | 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 |