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Pharmacokinetics of Propofol in Morbidly Obese Patients

Primary Purpose

Obesity, Morbid

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Propofol
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obesity, Morbid focused on measuring Bariatric surgery, Anesthetics, intravenous, Propofol, Pharmacokinetics

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pharmacokinetics

Arm Description

Propofol pharmacokinetics

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 10, 2012
Last Updated
May 26, 2017
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01536002
Brief Title
Pharmacokinetics of Propofol in Morbidly Obese Patients
Official Title
Pharmacokinetics (PK) of Propofol in Bariatric (Morbidly Obese) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 7, 2011 (Actual)
Primary Completion Date
May 7, 2014 (Actual)
Study Completion Date
May 7, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
Bariatric surgery, Anesthetics, intravenous, Propofol, Pharmacokinetics

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pharmacokinetics
Arm Type
Experimental
Arm Description
Propofol pharmacokinetics
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
Intravenous infusion over 30 min of Propofol 3-4 mg/kg body weight
Primary Outcome Measure Information:
Title
Propofol plasma concentrations
Description
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.
Time Frame
0-24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Heier, MD,PhD
Organizational Affiliation
Oslo University Hospital, Oslo, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0514
Country
Norway

12. IPD Sharing Statement

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Pharmacokinetics of Propofol in Morbidly Obese Patients

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