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Monitoring Exhaled Propofol to Individualize General Anesthesia

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01191021
Acronym
EPIGA
Enrollment
20
Registered
2010-08-30
Start date
2010-08-31
Completion date
2010-10-31
Last updated
2013-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia

Keywords

breath, propofol, general anesthesia

Brief summary

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.

Interventions

Volunteers will undergo propofol anesthesia for 90 min.

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Exhaled propofol (parts per billion)Continuous measurement over 90 min
Processed electroencephalography (Bispectral Index (0-100)): Change from baseline during anesthesiacontinuous over 90 min

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026