Morbid Obesity
Conditions
Keywords
Pharmacokinetics, Pharmacodynamics
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.
Interventions
DRUGpropofol
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.
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| plasma drug concentration of propofol | measured during the perioperative period | 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. |
Countries
United States
Outcome results
None listed