Propofol in Obese Children

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Treatments: Propofol

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 -