drugset / Trial / NCT01242241

Propofol in Obese Children

NCT01242241

Phase 3 Completed 80 enrolled Baylor College of Medicine
Non-randomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2008-04-01
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Propofol Small molecule 1 mg/kg Intravenous
Subject Propofol Small molecule 1.25 mg/kg Intravenous
Subject Propofol Small molecule 1.5 mg/kg Intravenous
Subject Propofol Small molecule 1.75 mg/kg Intravenous
Subject Propofol Small molecule 2 mg/kg Intravenous
Subject Propofol Small molecule 2.25 mg/kg Intravenous
Subject Propofol Small molecule 2.5 mg/kg Intravenous
Subject Propofol Small molecule 2.75 mg/kg Intravenous
Subject Propofol Small molecule 3 mg/kg Intravenous
Subject Propofol Small molecule 3.25 mg/kg Intravenous
Subject Propofol Small molecule 3.5 mg/kg Intravenous
Subject Propofol Small molecule 3.75 mg/kg Intravenous
Subject Propofol Small molecule 4 mg/kg Intravenous
Subject Propofol Small molecule 4.25 mg/kg Intravenous

Indications