Obesity, Morbid Clinical Trial
Official title:
Pharmacokinetics (PK) of Propofol in Bariatric (Morbidly Obese) Patients
Verified date | May 2017 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 69 |
Est. completion date | May 7, 2014 |
Est. primary completion date | May 7, 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 0-24 hours |
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