Pharmacokinetics of Propofol in Morbidly Obese Patients

Oslo University Hospital69 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Obesity, Morbid

Interventions

PropofolDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Oslo University Hospital

Oslo, Norway

Outcomes

Primary Outcomes

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.

Time frame: 0-24 hours

Data from ClinicalTrials.gov

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