General AnesthesiaNCT00532402
Continuous and Discontinuous Determination of Propofol Concentration in Breathing Gas
An observational study of General Anesthesia, run by University of Luebeck at 2 sites in Germany.
Trial summary
This study should compare the propofol concentration in breathing gas and in plasma (before and) after lung passage. Propofol concentrations in breathing gas are continuously measured by a sensor. For comparison a discontinuous method is used. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- General Anesthesia
- How many people
- 16 participants
- Where
- 2 sitesGermany
- Study dates
- Sep 2007to Dec 2010
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having general anesthesia for cardiac and non-cardiac operation
Who may be able to join
- Patient destined for general anesthesia
Who cannot join
- Heart insufficiency NYHA IV
- Allergy to propofol
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Dept. of Anesthesiology , UK-SH, Campus Luebeck
Lübeck, Schleswig-Holstein, D-23538
Dept. of Anesthesiology, UK-SH, Campus Luebeck
Lübeck, Schleswig-Holstein, D-23538
About this study
Official title: Continuous and Discontinuous Determination of Propofol Concentration in Breathing Gas - Compared With Propofol Concentration in Plasma (Before and) After Lung Passage and Neurophysiological Parameters
This study should compare the propofol concentration in breathing gas and in plasma (before and) after lung passage. Propofol concentrations in breathing gas are continuously measured by a sensor. For comparison a discontinuous method is used. Neurophysiologic parameters for determination of depth of anesthesia are compared to the continuous measured propofol concentration in breathing gas.
Study hypothesis: continuous measured propofol concentration in breathing gas correlates to propofol concentration in plasma and depth of anaesthesia.
- Conditions
- General Anesthesia
- Keywords
- Monitoring, Breathing Gas, Propofol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2007 (estimated)
- Study startSep 2007
- Study completionDec 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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Grossherr, University of Luebeck
- Investigators
- Hartmut Gehring, MD, PhD, Study director, Dept of Anesthesiology, UK-SH, Campus Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532402
- Sponsor's protocol ID
- P-A-S-1
- Status last verified
- Oct 2012
- First submitted
- 18 Sep 2007
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Grossherr M, Hengstenberg A, Meier T, Dibbelt L, Gerlach K, Gehring H. Discontinuous monitoring of propofol concentrations in expired alveolar gas and in arterial and venous plasma during artificial ventilation. Anesthesiology. 2006 Apr;104(4):786-90. doi: 10.1097/00000542-200604000-00024.
PubMed 16571975
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous and Discontinuous Determination of Propofol Concentration in Breathing Gas - Compared With Propofol Concentration in Plasma (Before and) After Lung Passage and Neurophysiological Parameters
- ClinicalTrials.gov ID
- NCT00532402
- Acronym / sponsor ID
- P-A-S-1
- Conditions
- General Anesthesia
- Keywords
- Monitoring, Breathing Gas, Propofol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Sep 2007
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Sep 2007 (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 study should compare the propofol concentration in breathing gas and in plasma (before and) after lung passage. Propofol concentrations in breathing gas are continuously measured by a sensor. For comparison a discontinuous method is used. Neurophysiologic parameters for determination of depth of anesthesia are compared to the continuous measured propofol concentration in breathing gas.
Study hypothesis: continuous measured propofol concentration in breathing gas correlates to propofol concentration in plasma and depth of anaesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having general anesthesia for cardiac and non-cardiac operation
Key inclusion criteria (1 listed)
- Patient destined for general anesthesia
Key exclusion criteria (2 listed)
- Heart insufficiency NYHA IV
- Allergy to propofol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 30 Oct 2012.
- Results publication: PubMed 16571975Grossherr M, Hengstenberg A, Meier T, Dibbelt L, Gerlach K, Gehring H. Discontinuous monitoring of propofol concentrations in expired alveolar gas and in arterial and venous plasma during artificial ventilation. Anesthesiology. 2006 Apr;104(4):786-90. doi: 10.1097/00000542-200604000-00024.
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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.
Hartmut Gehring, MD, PhD study director
Dept of Anesthesiology, UK-SH, Campus Luebeck
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthesia, run by University of Luebeck at 2 sites in Germany.
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 1 inclusion and 2 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 30 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00532402, 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 30 Oct 2012.