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NCT01191021 Clinical Trial

Monitoring Exhaled Propofol to Individualize General Anesthesia

General Anesthesia Clinical Trial

— EPIGA  

Official title:
Pilot Study to Estimate Central Propofol Effect by Measuring Exhaled Propofol Concentrations

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01191021
Other study ID # H54427-35579
Secondary ID
Status Completed
Phase Phase 1
First received July 20, 2010
Last updated June 4, 2013
Start date August 2010
Est. completion date October 2010

Study information
Verified date June 2013
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

Intervention

Drug:
• Propofol Anesthesia
Volunteers will undergo propofol anesthesia for 90 min.

Locations
Country Name City State
United States Department of Anesthesia and Perioperative Care, UCSF San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Exhaled propofol (parts per billion) Continuous measurement over 90 min Yes
Primary Processed electroencephalography (Bispectral Index (0-100)): Change from baseline during anesthesia continuous over 90 min Yes
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