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

NCT ID: NCT01591148

Last Updated: 2017-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Morbid Obesity

Keywords

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Pharmacokinetics Pharmacodynamics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

propofol

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Jerry Ingrande

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jerry Ingrande, M.D., M.S.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33079873 (View on PubMed)

Other Identifiers

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16509-JI

Identifier Type: OTHER

Identifier Source: secondary_id

Stanford-16509

Identifier Type: -

Identifier Source: org_study_id