Propofol in Obese Children

Completed · Phase 3

Conditions studied: Pharmacodynamics, Obesity

In brief

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.

Key facts

Study ID

NCT01242241

Run by

Baylor College of Medicine

People needed

80

Starts

2008-04-01

Expected to finish

2011-12-01

Last updated by the study team

2020-12-21

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• American Society of Anesthesiology(ASA) classification 1 or 2-

You may not qualify if…

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

Where it is running

• Texas Children's Hospital, Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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