NCT01591148

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2012

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

December 29, 2017

Status Verified

December 1, 2017

Enrollment Period

6.5 years

First QC Date

May 1, 2012

Last Update Submit

December 27, 2017

Conditions

Morbid Obesity

Keywords

PharmacokineticsPharmacodynamics

Outcome Measures

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.

    measured during the perioperative period

Study Arms (2)

Morbidly obese subjects

EXPERIMENTAL

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

Control subjects (body mass index 20-25)

ACTIVE COMPARATOR

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

propofolDRUG

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)Morbidly obese subjects

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

  • 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.

    PMID: 33079873DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Propofol

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Jerry Ingrande, M.D., M.S.

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 1, 2012

First Posted

May 3, 2012

Study Start

January 1, 2011

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

December 29, 2017

Record last verified: 2017-12

Locations

US(1)