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CompletedNCT01591148Updated Dec 29, 2017

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

A Phase 1 interventional study of propofol in Morbid Obesity, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-12-29.

Sponsored by Stanford University · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Morbid Obesity

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Keywords

  • Pharmacokinetics
  • Pharmacodynamics
03

In context

Obesity, Morbid

922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 590 interventional studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Drugpropofol

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: measured during the perioperative period

07

Study locations

1 site
  • Stanford University School of Medicine
    Stanford, California 94305, United States
08

References and documents

Publications

  • 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. PubMed 33079873 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01591148
Lead sponsor
Stanford University
Responsible party
Jerry Ingrande (Principal Investigator, Stanford University) — Principal investigator
First posted
May 3, 2012
Start date
Jan 2011
Primary completion
Jul 2017
Completion
Jul 2017
Last update
Dec 29, 2017

Study contacts

Jerry Ingrande, M.D., M.S.
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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