Pharmacokinetics of Propofol in Morbidly Obese Patients

• Status: Completed
• Trial end date: 2014-05-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oslo University Hospital
• Treatments: Propofol

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