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

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01591148
• Other study ID #: Stanford-16509
• Secondary ID: 16509-JI
• Status: Completed
• Phase: Phase 1
• First received: May 1, 2012
• Last updated: December 27, 2017
• Start date: January 2011
• Est. completion date: July 2017

Study information

• Verified date: December 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Drug:
• propofol
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.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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