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Monitoring Exhaled Propofol to Individualize General Anesthesia (EPIGA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01191021
First Posted: August 30, 2010
Last Update Posted: June 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose
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.

Condition Intervention Phase
General Anesthesia Drug: Propofol Anesthesia Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Participant)
Official Title: Pilot Study to Estimate Central Propofol Effect by Measuring Exhaled Propofol Concentrations

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Exhaled propofol (parts per billion) [ Time Frame: Continuous measurement over 90 min ]
  • Processed electroencephalography (Bispectral Index (0-100)): Change from baseline during anesthesia [ Time Frame: continuous over 90 min ]

Enrollment: 20
Study Start Date: August 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Propofol
Volunteers will receive propofol anesthesia on the study day.
Drug: Propofol Anesthesia
Volunteers will undergo propofol anesthesia for 90 min.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191021


Locations
United States, California
Department of Anesthesia and Perioperative Care, UCSF
San Francisco, California, United States, 94122
Sponsors and Collaborators
University of California, San Francisco
Investigators
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
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01191021     History of Changes
Other Study ID Numbers: H54427-35579
First Submitted: July 20, 2010
First Posted: August 30, 2010
Last Update Posted: June 5, 2013
Last Verified: June 2013

Keywords provided by University of California, San Francisco:
breath
propofol
general anesthesia

Additional relevant MeSH terms:
Anesthetics
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General