Monitoring Exhaled Propofol to Individualize General Anesthesia
EPIGA
Pilot Study to Estimate Central Propofol Effect by Measuring Exhaled Propofol Concentrations
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedFirst Posted
Study publicly available on registry
August 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedJune 5, 2013
June 1, 2013
2 months
July 20, 2010
June 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Exhaled propofol (parts per billion)
Continuous measurement over 90 min
Processed electroencephalography (Bispectral Index (0-100)): Change from baseline during anesthesia
continuous over 90 min
Study Arms (1)
Propofol
OTHERVolunteers will receive propofol anesthesia on the study day.
Interventions
Eligibility Criteria
You may qualify if:
- years of age
- Written informed consent
- Ability and willingness to give written informed consent
- American Society of Anesthesiologists (ASA) risk score I
You may not qualify if:
- Volunteers ASA physical status II - III
- Pregnancy
- Volunteers with history of neurological disease or stroke
- Volunteers with a history of recreational drug abuse
- Volunteers with a history of alcohol abuse
- Smokers
- Anesthesia within 6 months
- Known drug allergies
- History of adverse events during general anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesia and Perioperative Care, UCSF
San Francisco, California, 94122, United States
Related Publications (1)
Hornuss C, Praun S, Villinger J, Dornauer A, Moehnle P, Dolch M, Weninger E, Chouker A, Feil C, Briegel J, Thiel M, Schelling G. Real-time monitoring of propofol in expired air in humans undergoing total intravenous anesthesia. Anesthesiology. 2007 Apr;106(4):665-74. doi: 10.1097/01.anes.0000264746.01393.e0.
PMID: 17413903BACKGROUND
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2010
First Posted
August 30, 2010
Study Start
August 1, 2010
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
June 5, 2013
Record last verified: 2013-06