AnesthesiaNCT01029379
Pharmacogenetics of Propofol and Depth of Anesthesia
An observational study of Anesthesia and Propofol, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
Propofol, (2,6-diisopropylphenol) is a short-acting anesthetic drug used for induction and maintenance of anesthesia. The aim of this study is to evaluate plasma concentrations of propofol in relation to depth of anesthesia, measured by continuous EEG and to correlate plasma concentrations with genetic analyses of… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anesthesia, Propofol
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2010to Feb 2013
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: 200 patients, ASA classification 1 planned for elective surgery of at least 30 minutes duration
Who may be able to join
- Healthy caucasian patents,
- (ASAclassification 1) planned for elective surgery,
- with body mass index 20-30,
- free from analgetic drug > 12 hours prior to anesthesia
Who cannot join
- Pregnancy,
- Smoking,
- allergy to propofol or peanuts,
- alcohol abuse,
- non-caucasian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pharamocogenetices on Anesthesia Induction With Propofol
Propofol, (2,6-diisopropylphenol) is a short-acting anesthetic drug used for induction and maintenance of anesthesia.
The aim of this study is to evaluate plasma concentrations of propofol in relation to depth of anesthesia, measured by continuous EEG and to correlate plasma concentrations with genetic analyses of liver enzymes responsible for drug elimination.
Our hypothesis is that there is an individual requirement of Propofol plasma concentration depending on genetic differences in drug elimination.
200 patients, ASA classification 1, planned for elective surgery of a duration of at least 30 minutes will be included in this study.
- Conditions
- Anesthesia, Propofol
- Keywords
- propofol, depth of anesthesia, pharmacogenetics, Depth of anesthesia in correlation to plasma concentrations of propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 200 patients,ASA 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG pattern in correlation to clinical anesthesia
EEG pattern in correlation to clinical anesthesia
Measured: 20120101
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionFeb 2013
- Study completionFeb 2013
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 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Oscarsson, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029379
- Sponsor's protocol ID
- Progen1
- Status last verified
- Mar 2013
- First submitted
- 9 Dec 2009
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Khan MS, Zetterlund EL, Green H, Oscarsson A, Zackrisson AL, Svanborg E, Lindholm ML, Persson H, Eintrei C. Pharmacogenetics, plasma concentrations, clinical signs and EEG during propofol treatment. Basic Clin Pharmacol Toxicol. 2014 Dec;115(6):565-70. doi: 10.1111/bcpt.12277. Epub 2014 Jul 19.
PubMed 24891132
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pharamocogenetices on Anesthesia Induction With Propofol
- ClinicalTrials.gov ID
- NCT01029379
- Acronym / sponsor ID
- Progen1
- Conditions
- Anesthesia, Propofol
- Keywords
- propofol, depth of anesthesia, pharmacogenetics, Depth of anesthesia in correlation to plasma concentrations of propofol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 10 Dec 2009 (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, (2,6-diisopropylphenol) is a short-acting anesthetic drug used for induction and maintenance of anesthesia.
The aim of this study is to evaluate plasma concentrations of propofol in relation to depth of anesthesia, measured by continuous EEG and to correlate plasma concentrations with genetic analyses of liver enzymes responsible for drug elimination.
Our hypothesis is that there is an individual requirement of Propofol plasma concentration depending on genetic differences in drug elimination.
200 patients, ASA classification 1, planned for elective surgery of a duration of at least 30 minutes will be included in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 200 patients,ASA 1 | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 200 patients, ASA classification 1 planned for elective surgery of at least 30 minutes duration
Key inclusion criteria (4 listed)
- Healthy caucasian patents,
- (ASAclassification 1) planned for elective surgery,
- with body mass index 20-30,
- free from analgetic drug > 12 hours prior to anesthesia
Key exclusion criteria (5 listed)
- Pregnancy,
- Smoking,
- allergy to propofol or peanuts,
- alcohol abuse,
- non-caucasian
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
EEG pattern in correlation to clinical anesthesia
Time frame: 20120101
EEG pattern in correlation to clinical 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 4 Mar 2013.
- Derived from this study: PubMed 24891132Khan MS, Zetterlund EL, Green H, Oscarsson A, Zackrisson AL, Svanborg E, Lindholm ML, Persson H, Eintrei C. Pharmacogenetics, plasma concentrations, clinical signs and EEG during propofol treatment. Basic Clin Pharmacol Toxicol. 2014 Dec;115(6):565-70. doi: 10.1111/bcpt.12277. Epub 2014 Jul 19.
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Propofol, run by University Hospital, Linkoeping at 1 site in Sweden.
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 5 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 4 Mar 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 Sweden. 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?
EEG pattern in correlation to clinical anesthesia (time frame: 20120101). 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 NCT01029379, 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 4 Mar 2013.