Pharmacokinetics of Propofol in Morbidly Obese Patients

Phase 4

Completed

• Conditions: Obesity, Morbid
• Interventions: Drug: Propofol

• Registration Number: NCT01536002
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-07
• Study First Submitted: 2012-02-10
• Study First Submitted QC: 2012-02-15
• Study First Posted: 2012-02-20
• Primary Completion: 2014-05-07
• Study Completion: 2014-05-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-26
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pharmacokinetics	Propofol	Propofol pharmacokinetics

Primary Outcome Measures

Name	Time	Method
Propofol plasma concentrations	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.

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway