Obesity, MorbidPhase 4NCT01536002
Pharmacokinetics of Propofol in Morbidly Obese Patients
A Phase 4 study testing Propofol in people with Obesity, Morbid, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The objectives of this study are To determine PK of propofol in bariatric patients To identify the physiological variables that induce propofol PK changes in bariatric patients, when compared to a normal-weight population. To define context-sensitive half-time profiles for propofol in bariatric patients. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteNorway
- Study dates
- 7 Jun 2011to 7 May 2014
- Phase
- Phase 4
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Consecutive patients admitted to the Aker University Hospital, scheduled for general or bariatric surgery,
- Both genders. Female subjects of childbearing potential must be using adequate contraception (i.e. using oral or IM contraception or an IUCD) and must have a negative pregnancy test (urine beta-HCG).
- Aged 18 - 60 years, both inclusive
- Body mass index (BMI) ≥ 20 kg/m2
- Written informed consent
Who cannot join
- Patients that are considered not to tolerate a standard dose of propofol administered as a bolus.
- Known hypersensitivity to propofol or its ingredients (soy, lecithin, glycerol, oil acid)
- Known hypersensitivity to any of the anesthetic agents to be used
- Pregnant women
- Lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics (PK) of Propofol in Bariatric (Morbidly Obese) Patients
The objectives of this study are
- To determine PK of propofol in bariatric patients
- To identify the physiological variables that induce propofol PK changes in bariatric patients, when compared to a normal-weight population.
- To define context-sensitive half-time profiles for propofol in bariatric patients.
- Conditions
- Obesity, Morbid
- Being tested
- Propofol
- Keywords
- Bariatric surgery, Anesthetics, intravenous, Propofol, Pharmacokinetics
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan
Intravenous infusion over 30 min of Propofol 3-4 mg/kg body weight
| Study group | Role | What they receive |
|---|---|---|
| Pharmacokinetics | Experimental | Propofol pharmacokinetics Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propofol plasma concentrations
Arterial blood samples will be collected 0, 1, 2, 4, 8, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 480, 600, 720, and 1440 min after start of propofol bolus infusion. 2 samples will be collected at 0 and 1440 minutes, respectively. The remaining 6 blood samples will be collected according to a block sampling regimen, selected randomly within a time block containing 4 consecutive time points from the time point list noted above. In total 8 samples are drawn from each patient.
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study start7 Jun 2011
- Primary completion7 May 2014
- Study completion7 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Heier, Oslo University Hospital
- Investigators
- Tom Heier, MD,PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536002
- Sponsor's protocol ID
- 1.2007.366
- Status last verified
- May 2017
- First submitted
- 10 Feb 2012
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics (PK) of Propofol in Bariatric (Morbidly Obese) Patients
- ClinicalTrials.gov ID
- NCT01536002
- Acronym / sponsor ID
- 1.2007.366
- Conditions
- Obesity, Morbid
- Keywords
- Bariatric surgery, Anesthetics, intravenous, Propofol, Pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 7 Jun 2011 (actual)
- Primary completion
- 7 May 2014 (actual)
- Study completion
- 7 May 2014 (actual)
- First posted
- 20 Feb 2012 (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.
The objectives of this study are
- To determine PK of propofol in bariatric patients
- To identify the physiological variables that induce propofol PK changes in bariatric patients, when compared to a normal-weight population.
- To define context-sensitive half-time profiles for propofol in bariatric patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacokinetics | Experimental | Drug: PropofolPropofol pharmacokinetics |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Consecutive patients admitted to the Aker University Hospital, scheduled for general or bariatric surgery,
- Both genders. Female subjects of childbearing potential must be using adequate contraception (i.e. using oral or IM contraception or an IUCD) and must have a negative pregnancy test (urine beta-HCG).
- Aged 18 - 60 years, both inclusive
- Body mass index (BMI) ≥ 20 kg/m2
- Written informed consent
Key exclusion criteria (5 listed)
- Patients that are considered not to tolerate a standard dose of propofol administered as a bolus.
- Known hypersensitivity to propofol or its ingredients (soy, lecithin, glycerol, oil acid)
- Known hypersensitivity to any of the anesthetic agents to be used
- Pregnant women
- Lactating women
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 |
|---|---|---|
| PropofolAlso: DiprivanIntravenous infusion over 30 min of Propofol 3-4 mg/kg body weight | Drug | Pharmacokinetics |
Primary outcome
Propofol plasma concentrations
Time frame: 0-24 hours
Arterial blood samples will be collected 0, 1, 2, 4, 8, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 480, 600, 720, and 1440 min after start of propofol bolus infusion. 2 samples will be collected at 0 and 1440 minutes, respectively. The remaining 6 blood samples will be collected according to a block sampling regimen, selected randomly within a time block containing 4 consecutive time points from the time point list noted above. In total 8 samples are drawn from each patient.
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 31 May 2017.
Related trials for Obesity, Morbid
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
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.
Tom Heier, MD,PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol in people with Obesity, Morbid, run by Oslo University Hospital at 1 site in Norway.
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 5 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 31 May 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 Norway. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Propofol plasma concentrations (time frame: 0-24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2017.