A High Resolution Pharmacokinetic/Pharmacodynamic Model of Propofol in Morbidly Obese Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- plasma drug concentration of propofol
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Morbidly obese subjects
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.
Intervention: propofol (Drug)
Control subjects (body mass index 20-25)
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.
Intervention: propofol (Drug)
Outcomes
Primary Outcomes
plasma drug concentration of propofol
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Jerry Ingrande
Principal Investigator
Stanford University