Monitoring Exhaled Propofol to Individualize General Anesthesia (EPIGA)
This trial investigates the relationship between concentrations of the anesthetic drug propofol in exhaled breath, blood and drug effect in volunteers undergoing general anesthesia. The main goal of this study is to develop a pharmacokinetic - and dynamic model for propofol in exhaled breath.
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
|Official Title:||Pilot Study to Estimate Central Propofol Effect by Measuring Exhaled Propofol Concentrations|
- Exhaled propofol (parts per billion) [ Time Frame: Continuous measurement over 90 min ] [ Designated as safety issue: Yes ]
- Processed electroencephalography (Bispectral Index (0-100)): Change from baseline during anesthesia [ Time Frame: continuous over 90 min ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2010|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Volunteers will receive propofol anesthesia on the study day.
Drug: Propofol Anesthesia
Volunteers will undergo propofol anesthesia for 90 min.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191021
|United States, California|
|Department of Anesthesia and Perioperative Care, UCSF|
|San Francisco, California, United States, 94122|
|Principal Investigator:||Christian C Apfel, MD, PhD||Perioperative Clinical Research Core, Department of Anesthesia, University of California San Francisco|
|Principal Investigator:||Cyrill Hornuss, MD||Perioperative Clinical Research Core, Department of Anesthesia, University of California San Francisco|