Pharmacokinetics of Propofol in Morbidly Obese Patients

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01536002

Enrollment

Registered

2012-02-20

Start date

2011-06-07

Completion date

2014-05-07

Last updated

2017-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Morbid

Keywords

Bariatric surgery, Anesthetics, intravenous, Propofol, Pharmacokinetics

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.

Interventions

DRUGPropofol

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026