Pharmacokinetics of Propofol in Morbidly Obese Patients
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|ClinicalTrials.gov Identifier: NCT01536002|
Recruitment Status : Completed
First Posted : February 20, 2012
Last Update Posted : May 31, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity, Morbid||Drug: Propofol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetics (PK) of Propofol in Bariatric (Morbidly Obese) Patients|
|Actual Study Start Date :||June 7, 2011|
|Actual Primary Completion Date :||May 7, 2014|
|Actual Study Completion Date :||May 7, 2014|
Intravenous infusion over 30 min of Propofol 3-4 mg/kg body weight
Other Name: Diprivan
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01536002
|Oslo University Hospital|
|Oslo, Norway, 0514|
|Principal Investigator:||Tom Heier, MD,PhD||Oslo University Hospital, Oslo, Norway|