Phase 3
N=80
Propofol in Obese Children
Pharmacodynamics · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01242241 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Dose of Propofol That Caused Loss of Consciousness in 95% (ED95) of Obese and Non-obese Children — 2; 2.125 mg/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Propofol (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose of Propofol That Caused Loss of Consciousness in 95% (ED95) of Obese and Non-obese Children |
2; 2.125 | — |
| SECONDARY Depth of Sedation |
3.65; 3.57; 3.86; 3.73; 3.82; 3.67 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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 -
Data sourced from ClinicalTrials.gov (NCT01242241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.