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Pharmacokinetics of Propofol in Morbidly Obese Patients

This study is currently recruiting participants.
Verified February 2012 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01536002
First received: February 10, 2012
Last updated: February 15, 2012
Last verified: February 2012
History of Changes
  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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pharmacokinetics (PK) of Propofol in Bariatric (Morbidly Obese) Patients

Resource links provided by NLM:

MedlinePlus related topics: Obesity
Drug Information available for: Propofol
U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Propofol plasma concentrations [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: June 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536002

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0514
Contact: Tom Heier, Ph.d     22894000     tom.heier@medisin.uio.no    
Contact: Martin Braathen, MD     22894000     martin.braathen@gmail.com    
Principal Investigator: Martin Braathen, MD            
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Tom Heier, MD,PhD Oslo University Hospital, Oslo, Norway
  More Information

No publications provided

Responsible Party: 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: February 15, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

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

ClinicalTrials.gov processed this record on May 16, 2013