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Monitoring Exhaled Propofol to Individualize General Anesthesia (EPIGA)

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01191021
First received: July 20, 2010
Last updated: February 15, 2011
Last verified: August 2010
History of Changes
  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
General Anesthesia
 Drug: Propofol Anesthesia

Study Type: Interventional
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

Resource links provided by NLM:

Drug Information available for: Propofol
U.S. FDA Resources

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 ] [ 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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: Christian C. Apfel, MD,PhD, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01191021     History of Changes
Other Study ID Numbers: H54427-35579
Study First Received: July 20, 2010
Last Updated: February 15, 2011
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 22, 2013