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Completed

NCT Number: NCT01191021

Monitoring Exhaled Propofol to Individualize General Anesthesia

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.

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Key information

Conditions

General Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Anesthesia and Perioperative Care, UCSF

San Francisco, California, 94122, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

propofol anesthesia

Drug

Volunteers will undergo propofol anesthesia for 90 min.

Primary outcomes

  1. Exhaled propofol (parts per billion)

    Time frame: Continuous measurement over 90 min

  2. Processed electroencephalography (Bispectral Index (0-100)): Change from baseline during anesthesia

    Time frame: continuous over 90 min

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Acronym: EPIGA

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 30, 2010
Registry last updated
Jun 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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