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Propofol in Obese Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Baylor College of Medicine.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01242241
First Posted: November 16, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Baylor College of Medicine
  Purpose
Obesity in children,as in adults,has rapidly become a public health concern. Studies in adults have shown that obesity, now considered to be a disease state, is a modifier of the effect of drugs on the body as well as how the body handles the drug.The anesthetic management of obese children poses a variety of significant challenges which include determination of the appropriate dose of anesthetic intravenous agents. Dosing of most drugs is calculated based on the effective dose in 50% of patients but the more practical and required information is the effective dose in 95%(ED95%)of patients. The aim of this study is to determine the effective dose in 95% of patients(children). The hypothesis is the ED95 of propofol in obese children will be higher than that of non-obese children.

Condition Intervention
Pharmacodynamics Obesity Drug: Propofol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Propofol in Obese Children

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Loss of consciousness [ Time Frame: 20 seconds ]
    Propofol is administered over 10 seconds. 20 seconds after adminstration, loss of consciousness is assessed by the presence or absence of a lash reflex.


Secondary Outcome Measures:
  • Depth of sedation [ Time Frame: 2 minutes ]
    2 minutes after propofol adminstration, the patient is assessed for depth of sedation using the University of Michigan sedation scale and the Ramsey sedation scale


Estimated Enrollment: 80
Study Start Date: April 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Non-obese
Non-obese children categorized as those with a body mass index(BMI)between 25-84th percentile
Drug: Propofol
This arm of patients(non-obese)will act as the control group for the obese children. Each non-obese child/subject will receive a predetermined dose of propofol from a range of 1.0mg/kg to 4.25mg/kg depending on the response of the previous patient to their assigned dose( biased coin design)
Other Name: Diprivan
Active Comparator: Obese children
Obese children are categorized as those with a body mass index >95th percentile
Drug: Propofol
Each Obese child/subject in this group will receive a predetermined dose of propofol ranging from 1.0mg/kg to 4.25mg/kg to induce loss of consciousness depending on the response (presence or absence of lash reflex) of the preceding patient to his/her assigned dose (biased coin design)
Other Name: Diprivan

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children between the ages of 3 and 17 years who fall into the categories of non-obese(BMI percentile between 25-84th percentile) or obese(>95th percentile)
  2. American Society of Anesthesiology(ASA) classification 1 or 2-

Exclusion Criteria:

  1. Patients classified as ASA (American Society of Anesthesiology) Class 3 or greater.
  2. Patients with documented kidney or liver disease or those presenting for open surgery on the liver or kidney.
  3. Patients who will NOT be receiving propofol for induction as part of their anesthetic regimen.
  4. Patients who are currently on anti-convulsant medication or receiving drugs with sedative effects.
  5. Patients currently being treated for attention deficit disorder.
  6. Patients who are diagnosed with failure to thrive or those with a BMI less than 25th percentile.
  7. Patients who are hemodynamically unstable.
  8. Patients with egg allergy.
  9. Patients with low levels of albumin -
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01242241


Contacts
Contact: Olutoyin A Olutoye, M.D 832-824-5800 oao@bcm.edu
Contact: Deborah East, RN,BS,BA,CCRC 832-824-5913 dleast@texaschildrenshospital.org

Locations
United States, Texas
Texas Children's Hospital, Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Olutoyin A Olutoye, MD    832-824-5800    oao@bcm.edu   
Contact: Deborah East, RN    832-824-5913    dleast@texaschildrenshospital.org   
Principal Investigator: Olutoyin A Olutoye, MD         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Olutoyin A Olutoye, MD Baylor College of Medicine
  More Information

Publications:
Responsible Party: Olutoyin Olutoye M.D/Associate Professor of Anesthesiology & Pediatrics, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01242241     History of Changes
Other Study ID Numbers: H-22091
First Submitted: November 15, 2010
First Posted: November 16, 2010
Last Update Posted: October 12, 2017
Last Verified: November 2010

Keywords provided by Baylor College of Medicine:
Propofol
Childhood obesity
Pharmacodynamics

Additional relevant MeSH terms:
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics