General AnesthesiaPhase 1EPIGANCT01191021
Monitoring Exhaled Propofol to Individualize General Anesthesia
A Phase 1 study testing Propofol Anesthesia in people with General Anesthesia, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Propofol Anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Oct 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age
- Written informed consent
- Ability and willingness to give written informed consent
- American Society of Anesthesiologists (ASA) risk score I
Who cannot join
- 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
Show all 9Show fewer
- Anesthesia within 6 months
- Known drug allergies
- History of adverse events during general anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Anesthesia and Perioperative Care, UCSF
San Francisco, California, 94122
About this study
Official title: 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.
- Conditions
- General Anesthesia
- Being tested
- Propofol Anesthesia
- Keywords
- breath, propofol, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol AnesthesiaDrug
Volunteers will undergo propofol anesthesia for 90 min.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Other | Volunteers will receive propofol anesthesia on the study day. Receives: Drug: Propofol Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled propofol (parts per billion)
Measured: Continuous measurement over 90 min
Processed electroencephalography (Bispectral Index (0-100)): Change from baseline during anesthesia
Measured: continuous over 90 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian C Apfel, MD, PhD, Principal investigator, Perioperative Clinical Research Core, Department of Anesthesia, University of California San FranciscoCyrill Hornuss, MD, Principal investigator, Perioperative Clinical Research Core, Department of Anesthesia, University of California San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191021
- Sponsor's protocol ID
- H54427-35579
- Acronym
- EPIGA
- Status last verified
- Jun 2013
- First submitted
- 20 Jul 2010
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Hornuss C, Praun S, Villinger J, Dornauer A, Moehnle P, Dolch M, Weninger E, Chouker A, Feil C, Briegel J, Thiel M, Schelling G. Real-time monitoring of propofol in expired air in humans undergoing total intravenous anesthesia. Anesthesiology. 2007 Apr;106(4):665-74. doi: 10.1097/01.anes.0000264746.01393.e0.
PubMed 17413903
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Estimate Central Propofol Effect by Measuring Exhaled Propofol Concentrations
- ClinicalTrials.gov ID
- NCT01191021
- Acronym / sponsor ID
- EPIGA / H54427-35579
- Conditions
- General Anesthesia
- Keywords
- breath, propofol, general anesthesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 30 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propofol | Other | Drug: Propofol AnesthesiaVolunteers will receive propofol anesthesia on the study day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol AnesthesiaVolunteers will undergo propofol anesthesia for 90 min. | Drug | Propofol |
Primary outcome
Exhaled propofol (parts per billion)
Time frame: Continuous measurement over 90 min
Processed electroencephalography (Bispectral Index (0-100)): Change from baseline during anesthesia
Time frame: continuous over 90 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
- Background: PubMed 17413903Hornuss C, Praun S, Villinger J, Dornauer A, Moehnle P, Dolch M, Weninger E, Chouker A, Feil C, Briegel J, Thiel M, Schelling G. Real-time monitoring of propofol in expired air in humans undergoing total intravenous anesthesia. Anesthesiology. 2007 Apr;106(4):665-74. doi: 10.1097/01.anes.0000264746.01393.e0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian C Apfel, MD, PhD principal investigator
Perioperative Clinical Research Core, Department of Anesthesia, University of California San Francisco
Cyrill Hornuss, MD principal investigator
Perioperative Clinical Research Core, Department of Anesthesia, University of California San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Propofol Anesthesia in people with General Anesthesia, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exhaled propofol (parts per billion) (time frame: Continuous measurement over 90 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01191021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2013; AzTrials last refreshed its copy on 8 Nov 2026.