Pharmacokinetics of Propofol in 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.

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Key information

Conditions

Obesity, Morbid Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oslo University Hospital

Oslo, 0514, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

Intravenous infusion over 30 min of Propofol 3-4 mg/kg body weight

Other names: Diprivan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Pharmacokinetics (PK) of Propofol in Bariatric (Morbidly Obese) Patients

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Feb 20, 2012
Registry last updated: May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed