Propofol in Obese Children

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. Identifier: NCT01242241
Recruitment Status : Unknown
Verified November 2010 by Baylor College of Medicine.
Recruitment status was:  Recruiting
First Posted : November 16, 2010
Last Update Posted : November 16, 2010
Information provided by:
Baylor College of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Pharmacodynamics Obesity Drug: Propofol Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Propofol in Obese Children
Study Start Date : April 2008
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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

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

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 -

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 identifier (NCT number): NCT01242241

Contact: Olutoyin A Olutoye, M.D 832-824-5800
Contact: Deborah East, RN,BS,BA,CCRC 832-824-5913

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   
Contact: Deborah East, RN    832-824-5913   
Principal Investigator: Olutoyin A Olutoye, MD         
Sponsors and Collaborators
Baylor College of Medicine
Principal Investigator: Olutoyin A Olutoye, MD Baylor College of Medicine

Responsible Party: Olutoyin Olutoye M.D/Associate Professor of Anesthesiology & Pediatrics, Baylor College of Medicine Identifier: NCT01242241     History of Changes
Other Study ID Numbers: H-22091
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: November 16, 2010
Last Verified: November 2010

Keywords provided by Baylor College of Medicine:
Childhood obesity

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