Status:
COMPLETED
Propofol in Obese Children
Lead Sponsor:
Baylor College of Medicine
Conditions:
Pharmacodynamics
Obesity
Eligibility:
All Genders
3-17 years
Phase:
PHASE3
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 th...
Detailed Description
All subjects were fasted in keeping with our institutional NPO guidelines and had IV access established in the upper extremity in the pre-anesthesia area. No pre-induction sedative drugs were administ...
Eligibility Criteria
Inclusion
- 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-
Exclusion
- 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 -
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01242241
Start Date
April 1 2008
End Date
December 1 2011
Last Update
December 21 2020
Active Locations (1)
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1
Texas Children's Hospital, Baylor College of Medicine
Houston, Texas, United States, 77030