View Clinical Trial (Medical Research Study)
Propofol in Obese Children
| City: |
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Houston |
| State: |
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Texas |
| Zip Code: |
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77030 |
| Conditions: |
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Pharmacodynamics - Obesity |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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 -
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| NCT ID: |
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NCT01242241 |
| Primary Contact: |
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Principal Investigator
Olutoyin A Olutoye, MD
Baylor College of Medicine
Olutoyin A Olutoye, M.D
Phone: 832-824-5800
Email: oao@bcm.edu
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| Backup Contact: |
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Email: dleast@texaschildrenshospital.org
Deborah East, RN,BS,BA,CCRC
Phone: 832-824-5913
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| Location Contact: |
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Houston, Texas 77030
United States
Olutoyin A Olutoye, MD
Phone: 832-824-5800
Email: oao@bcm.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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