Monitoring Exhaled Propofol to Individualize General Anesthesia (EPIGA)

June 4, 2013 updated by: University of California, San Francisco

Pilot Study to Estimate Central Propofol Effect by Measuring Exhaled Propofol Concentrations

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94122
        • Department of Anesthesia and Perioperative Care, UCSF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Propofol
Volunteers will receive propofol anesthesia on the study day.
Drug: Propofol Anesthesia
Volunteers will undergo propofol anesthesia for 90 min.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

July 20, 2010

First Submitted That Met QC Criteria

August 26, 2010

First Posted (ESTIMATE)

August 30, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 5, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H54427-35579

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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