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Pharmacokinetics of Propofol in Morbidly Obese Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01536002
First Posted: February 20, 2012
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tom Heier, Oslo University Hospital
February 10, 2012
February 20, 2012
May 31, 2017
June 7, 2011
May 7, 2014   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01536002 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacokinetics of Propofol in Morbidly Obese Patients
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.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Obesity, Morbid
Drug: Propofol
Intravenous infusion over 30 min of Propofol 3-4 mg/kg body weight
Other Name: Diprivan
Experimental: Pharmacokinetics
Propofol pharmacokinetics
Intervention: Drug: Propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
May 7, 2014
May 7, 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01536002
1.2007.366
No
Not Provided
Not Provided
Tom Heier, Oslo University Hospital
Oslo University Hospital
Not Provided
Principal Investigator: Tom Heier, MD,PhD Oslo University Hospital, Oslo, Norway
Oslo University Hospital
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP