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

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ClinicalTrials.gov Identifier: NCT01591148
Recruitment Status : Completed
First Posted : May 3, 2012
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
Jerry Ingrande, 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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Drug: propofol Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A High Resolution Pharmacokinetic/Pharmacodynamic Model of Propofol in Morbidly Obese Subjects
Study Start Date : January 2011
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591148


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Jerry Ingrande, M.D., M.S. Stanford University

Responsible Party: Jerry Ingrande, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01591148     History of Changes
Other Study ID Numbers: Stanford-16509
16509-JI ( Other Identifier: Stanford University )
First Posted: May 3, 2012    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017

Keywords provided by Jerry Ingrande, Stanford University:
Pharmacokinetics
Pharmacodynamics

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