A High Resolution Pharmacokinetic/Pharmacodynamic Model of Propofol in Morbidly Obese Subjects

Study Overview
=================
Brief Summary
-----------------
This study will determine how morbid obesity affects the distribution and metabolism of the drug propofol. The investigators hypothesize that propofol will be distributed and metabolized differently in morbidly obese subjects as compared to normal weight subjects.

Official Title
-----------------
A High Resolution Pharmacokinetic/Pharmacodynamic Model of Propofol in Morbidly Obese Subjects

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Drug: propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult age (ages 18-70) body mass index greater than 40 or between 20-25 American Society of Anesthesiologists Class I, II, or III undergoing elective surgical procedure requiring general anesthesia Exclusion Criteria: evidence of cardiovascular or pulmonary disease kidney or liver dysfunction drug allergy to propofol history of difficult airway on prescribed or over the counter anxiolytics, antipsychotics, or sleeping aids unable to speak or understand English

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Morbidly obese subjects<br>Morbidly obese subjects (body mass index greater than 40) will be given propofol for induction of general anesthesia. Plasma samples will be taken to ascertain drug concentration over time. | Drug: propofol<br>* Morbidly obese subjects (body mass index greater than 40)and control subjects (body mass index 20-25) will be given propofol for induction of general anesthesia. Plasma samples will be taken to ascertain drug concentration over time.<br>|
| Active Comparator: Control subjects (body mass index 20-25)<br>Normal weight subjects (body mass index 20-25) will be given propofol during induction of general anesthesia. Plasma samples will be collected over time to ascertain propofol plasma concentration. | Drug: propofol<br>* Morbidly obese subjects (body mass index greater than 40)and control subjects (body mass index 20-25) will be given propofol for induction of general anesthesia. Plasma samples will be taken to ascertain drug concentration over time.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma drug concentration of propofol | Plasma concentration over time will be measured and modeled in order to calculate drug clearance, volume of distribution, area under the curve, and micro rate constants. Knowledge of these variables will allow safer administration of anesthetic drug administration in the obese population. Knowledge of these parameters will allow propofol to be administered safely in morbily obese subjects. | measured during the perioperative period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Pharmacodynamics