Pharmacokinetics of Propofol in Morbidly Obese Patients

University of Oslo (UIO)

Status and phase: Completed; Phase 4

Conditions: Obesity, Morbid

Treatments: Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT01536002

1.2007.366

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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69 participants in 1 patient group

Pharmacokinetics

Experimental group

Description:

Propofol pharmacokinetics

Treatment:

Drug: Propofol