Back to resultsA High Resolution Pharmacokinetic/Pharmacodynamic Model of Propofol in Morbidly Obese Subjects
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
propofol
Sponsored by
About this trial
This is an interventional other trial for Morbid Obesity focused on measuring Pharmacokinetics, Pharmacodynamics
Eligibility 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
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Morbidly obese subjects
Control subjects (body mass index 20-25)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01591148
Brief Title
A High Resolution Pharmacokinetic/Pharmacodynamic Model of Propofol in Morbidly Obese Subjects
Official Title
A High Resolution Pharmacokinetic/Pharmacodynamic Model of Propofol in Morbidly Obese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Pharmacokinetics, Pharmacodynamics
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Morbidly obese subjects
Arm Type
Experimental
Arm Description
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.
Arm Title
Control subjects (body mass index 20-25)
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
propofol
Intervention Description
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 Measure Information:
Title
plasma drug concentration of propofol
Description
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.
Time Frame
measured during the perioperative period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry Ingrande, M.D., M.S.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33079873
Citation
Ingrande J, Gabriel RA, McAuley J, Krasinska K, Chien A, Lemmens HJM. The Performance of an Artificial Neural Network Model in Predicting the Early Distribution Kinetics of Propofol in Morbidly Obese and Lean Subjects. Anesth Analg. 2020 Nov;131(5):1500-1509. doi: 10.1213/ANE.0000000000004897.
Results Reference
derived
Learn more about this trial
A High Resolution Pharmacokinetic/Pharmacodynamic Model of Propofol in Morbidly Obese Subjects
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