Pharmacokinetics of Propofol in Morbidly Obese Patients
Pharmacokinetics (PK) of Propofol in Bariatric (Morbidly Obese) Patients
1 other identifier
interventional
69
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2011
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 7, 2011
CompletedFirst Submitted
Initial submission to the registry
February 10, 2012
CompletedFirst Posted
Study publicly available on registry
February 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 7, 2014
CompletedMay 31, 2017
May 1, 2017
2.9 years
February 10, 2012
May 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
0-24 hours
Study Arms (1)
Pharmacokinetics
EXPERIMENTALPropofol pharmacokinetics
Interventions
Intravenous infusion over 30 min of Propofol 3-4 mg/kg body weight
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oslo University Hospital
Oslo, 0514, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tom Heier, MD,PhD
Oslo University Hospital, Oslo, Norway
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 10, 2012
First Posted
February 20, 2012
Study Start
June 7, 2011
Primary Completion
May 7, 2014
Study Completion
May 7, 2014
Last Updated
May 31, 2017
Record last verified: 2017-05