- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01591148
A High Resolution Pharmacokinetic/Pharmacodynamic Model of Propofol in Morbidly Obese Subjects
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
measured during the perioperative period
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Stanford-16509
- 16509-JI (Other Identifier: Stanford University)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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