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Pharmacokinetics of Propofol in Morbidly Obese Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tom Heier, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01536002
First received: February 10, 2012
Last updated: May 26, 2017
Last verified: May 2017
  Purpose

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 Intervention Phase
Obesity, Morbid Drug: Propofol Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: Pharmacokinetics (PK) of Propofol in Bariatric (Morbidly Obese) Patients

Resource links provided by NLM:


Further study details as provided by Tom Heier, Oslo University Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 69
Actual Study Start Date: June 7, 2011
Study Completion Date: May 7, 2014
Primary Completion Date: May 7, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pharmacokinetics
Propofol pharmacokinetics
Drug: Propofol
Intravenous infusion over 30 min of Propofol 3-4 mg/kg body weight
Other Name: Diprivan

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536002

Locations
Norway
Oslo University Hospital
Oslo, Norway, 0514
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Tom Heier, MD,PhD Oslo University Hospital, Oslo, Norway
  More Information

Responsible Party: Tom Heier, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01536002     History of Changes
Other Study ID Numbers: 1.2007.366
Study First Received: February 10, 2012
Last Updated: May 26, 2017

Keywords provided by Tom Heier, Oslo University Hospital:
Bariatric surgery
Anesthetics, intravenous
Propofol
Pharmacokinetics

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on July 21, 2017