Urological DiseaseNCT01835340
Breath Gas Measurement of Propofol During Anesthesia in Patients With Endourological Procedures
A study testing Drug: Propofol Anesthesia Patients will undergo propofol anesthesia. in people with Urological Disease, run by University of Luebeck at 1 site in Germany.
Trial summary
Propofol can be measured continuously in breath gas during anesthesia. This study compares propofol concentration in plasma and breath gas and processed electroencephalographic monitoring (bispectral index) under clinical conditions with patients and total intravenous anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urological Disease
- What is being tested?
- Drug: Propofol Anesthesia Patients will undergo propofol anesthesia.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to 9 Dec 2017
- Phase
- Interventional
- 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-II
Who cannot join
- Denial of the patient
- Patients ASA physical status III- IV
- Pregnancy
- Volunteers with history of neurological disease or stroke
- Volunteers with a history of recreational drug abuse
- Volunteers with a history of alcohol abuse
Show all 9Show fewer
- Known drug allergies
- History of adverse events during general anesthesia
- Total intravenous anesthesia not practicable
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Anesthesiology and Intensive Care
Lübeck, Schleswig-Holstein, 23538
About this study
Official title: Study to Estimate Central Propofol Effect by Measuring Exhaled Propofol Concentrations in Patients
Propofol can be measured continuously in breath gas during anesthesia. This study compares propofol concentration in plasma and breath gas and processed electroencephalographic monitoring (bispectral index) under clinical conditions with patients and total intravenous anesthesia. Target controlled infusion technique is used to deliver adequate propofol concentration in plasma.
- Conditions
- Urological Disease
- Being tested
- Drug: Propofol Anesthesia Patients will undergo propofol anesthesia.
- Medical subject headings
- Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: Propofol Anesthesia Patients will undergo propofol anesthesia.Device
| Study group | Role | What they receive |
|---|---|---|
| propofol | Experimental | Propofol Patients will receive propofol anesthesia on the study day Receives: Device: Drug: Propofol Anesthesia Patients will undergo 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 40 min during the induction of anesthesia and 30 min during recovery of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startOct 2012
- Primary completion9 Dec 2017
- Study completion9 Dec 2017
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 Urological DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Collaborators
- Draeger
- Responsible party
- Principal investigator, Martin Grossherr, University of Luebeck
- Investigators
- Hartmut Gehring, Professor, Principal investigator, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835340
- Sponsor's protocol ID
- NCT01835340
- Status last verified
- Dec 2017
- First submitted
- 15 Apr 2013
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Grossherr M, Hengstenberg A, Meier T, Dibbelt L, Igl BW, Ziegler A, Schmucker P, Gehring H. Propofol concentration in exhaled air and arterial plasma in mechanically ventilated patients undergoing cardiac surgery. Br J Anaesth. 2009 May;102(5):608-13. doi: 10.1093/bja/aep053. Epub 2009 Mar 31.
PubMed 19336539
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Estimate Central Propofol Effect by Measuring Exhaled Propofol Concentrations in Patients
- ClinicalTrials.gov ID
- NCT01835340
- Acronym / sponsor ID
- NCT01835340
- Conditions
- Urological Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Collaborators
- Draeger
- Study start
- Oct 2012
- Primary completion
- 9 Dec 2017 (actual)
- Study completion
- 9 Dec 2017 (actual)
- First posted
- 18 Apr 2013 (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.
Propofol can be measured continuously in breath gas during anesthesia. This study compares propofol concentration in plasma and breath gas and processed electroencephalographic monitoring (bispectral index) under clinical conditions with patients and total intravenous anesthesia. Target controlled infusion technique is used to deliver adequate propofol concentration in plasma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| propofol | Experimental | Device: Drug: Propofol Anesthesia Patients will undergo propofol anesthesia.Propofol Patients 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
- Written informed consent
- Ability and willingness to give written informed consent
- American Society of Anesthesiologists (ASA) risk score I-II
Key exclusion criteria (9 listed)
- Denial of the patient
- Patients ASA physical status III- IV
- Pregnancy
- Volunteers with history of neurological disease or stroke
- Volunteers with a history of recreational drug 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 |
|---|---|---|
| Drug: Propofol Anesthesia Patients will undergo propofol anesthesia. | Device | propofol |
Primary outcome
Exhaled propofol (parts per billion)
Time frame: Continuous measurement over 40 min during the induction of anesthesia and 30 min during recovery of anesthesia
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 12 Dec 2017.
- Background: PubMed 19336539Grossherr M, Hengstenberg A, Meier T, Dibbelt L, Igl BW, Ziegler A, Schmucker P, Gehring H. Propofol concentration in exhaled air and arterial plasma in mechanically ventilated patients undergoing cardiac surgery. Br J Anaesth. 2009 May;102(5):608-13. doi: 10.1093/bja/aep053. Epub 2009 Mar 31.
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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, Professor principal investigator
University of Luebeck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug: Propofol Anesthesia Patients will undergo propofol anesthesia. in people with Urological Disease, run by University of Luebeck at 1 site 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 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 12 Dec 2017. 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 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.
What does the primary outcome measure?
Exhaled propofol (parts per billion) (time frame: Continuous measurement over 40 min during the induction of anesthesia and 30 min during recovery of anesthesia). 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 NCT01835340, 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 12 Dec 2017.