Monitoring Exhaled Propofol to Individualize General Anesthesia
Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: General Anesthesia
Intervention: Propofol Anesthesia (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: University of California, San Francisco Official(s) and/or principal investigator(s): Christian C Apfel, MD, PhD, Principal Investigator, Affiliation: Perioperative Clinical Research Core, Department of Anesthesia, University of California San Francisco Cyrill Hornuss, MD, Principal Investigator, Affiliation: Perioperative Clinical Research Core, Department of Anesthesia, University of California San Francisco
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.
Clinical Details
Official title: Pilot Study to Estimate Central Propofol Effect by Measuring Exhaled Propofol Concentrations
Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)
Primary outcome: Exhaled propofol (parts per billion)Processed electroencephalography (Bispectral Index (0-100)): Change from baseline during anesthesia
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 18 years of age
- Written informed consent
- Ability and willingness to give written informed consent
- American Society of Anesthesiologists (ASA) risk score I
Exclusion Criteria:
- 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
Locations and Contacts
Department of Anesthesia and Perioperative Care, UCSF, San Francisco, California 94122, United States
Additional Information
Related publications: 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.
Starting date: August 2010
Last updated: June 4, 2013
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