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

Phase 1

Completed

• Conditions: Morbid Obesity
• Interventions: Drug: propofol

• Registration Number: NCT01591148
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-05-01
• Study First Submitted QC: 2012-05-02
• Study First Posted: 2012-05-03
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-27
• Last Update Posted: 2017-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morbidly obese subjects	propofol	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.
Control subjects (body mass index 20-25)	propofol	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States