Pharmacokinetics of Propofol in Morbidly Obese Patients

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536002
• Other study ID #: 1.2007.366
• Status: Completed
• Phase: Phase 4
• First received: February 10, 2012
• Last updated: May 26, 2017
• Start date: June 7, 2011
• Est. completion date: May 7, 2014

Study information

• Verified date: May 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: May 7, 2014
• Est. primary completion date: May 7, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

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

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0-24 hours