Pharmacokinetics of Propofol in Morbidly Obese Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-07

Study Completion Date

2014-05-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity, Morbid

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Pharmacokinetics

Propofol pharmacokinetics

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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

Interventions

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Propofol

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

Intervention Type DRUG

Other Intervention Names

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Diprivan

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes