Monitoring Exhaled Propofol to Individualize General Anesthesia (EPIGA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01191021
First received: July 20, 2010
Last updated: June 4, 2013
Last verified: June 2013
  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: 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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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: June 4, 2013
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
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014