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

This study is currently recruiting participants.
Verified May 2012 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Jerry Ingrande, Stanford University
ClinicalTrials.gov Identifier:
NCT01591148
First received: May 1, 2012
Last updated: May 3, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Morbid Obesity
 Drug: propofol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A High Resolution Pharmacokinetic/Pharmacodynamic Model of Propofol in Morbidly Obese Subjects

Resource links provided by NLM:

MedlinePlus related topics: Obesity
Drug Information available for: Propofol
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • plasma drug concentration of propofol [ Time Frame: measured during the perioperative period ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 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.
Active Comparator: 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.
 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591148

Contacts
Contact: Jerry Ingrande, M.D., M.S. 650-723-7377 jerryi@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Jerry Ingrande, M.D., M.S.     650-723-7377     jerryi@stanford.edu    
Principal Investigator: Jerry Ingrande, M.D., M.S.            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Jerry Ingrande, M.D., M.S. Stanford University
  More Information

No publications provided

Responsible Party: Jerry Ingrande, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01591148     History of Changes
Other Study ID Numbers: Stanford-16509, 16509-JI
Study First Received: May 1, 2012
Last Updated: May 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Pharmacokinetics
Pharmacodynamics

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Propofol
Anesthetics, Intravenous
 Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on June 18, 2013