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NCT00948597 · ClinicalTrials.gov registry record
Development of PK/PD Model for Individualized Propofol Dosing
A clinical trial of Obesity and Elective Surgery, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- 26
- Enrollment target
- 1
- Study location
NCT00948597 is a study of Obesity and Elective Surgery that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 26 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00948597, a study of Obesity and Elective Surgery, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
The U.S. National Health and Nutrition Examination Survey of 1994 indicated that 59% of American men and 49% of women have body mass indexes (BMIs) over 25. Extreme obesity, defined as a BMI of 40 or more, was found in 2% of the men and 4% of the women \[http://www.cdc.gov/nchs/nhanes.htm\]. The newest survey in 2007 indicates an alarming increase in BMI; 63% of Americans are overweight, with 26% now in the obese category. With extreme obesity as high as 26-30% in adults, obesity percentages in children are also sharply on the rise. These alarming numbers pose a major clinical problem in terms of the safe and effective use of drugs in children. Obesity may alter the disposition and/or clearance of drugs in the body as well as the response, which should be considered when using anesthetics in these patients. Total intravenous anesthesia (TIVA) with propofol is widely used in children, adolescents and adults undergoing surgery, because of rapid onset of action, ease of titration and rapid offset of action. While extensive research on optimal propofol dosing has been performed in non-obese adults, including in critically ill mechanically ventilated adult patients by the investigators' collaborators, there is no evidence on required dosages in morbidly obese adult or pediatric patients of this highly lipophilic agent. As a consequence, serious problems do arise due to under- and overdosing, increasing the risk of inadequate effects and adverse events, respectively. Crucial additional information is needed on the pharmacokinetics of drugs used in morbidly obese children to improve safety and efficacy. This proposal will test a novel approach by identifying pharmacokinetic/pharmacodynamic (PK/PD) factors that are associated with response to therapy and adverse events. If successful, this study will provide proof of concept data for PK/PD model-based dosing strategy that can be implemented into daily clinical care to allow tailoring of dose to individual needs. Propofol
Conditions Studied
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2009-07 |
| Est. Completion | 2013-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00948597
The ClinicalTrials.gov registry entry for NCT00948597 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (97% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 0 interventions.
NCT00948597 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT00948597 about?
NCT00948597 is a clinical study titled "Development of PK/PD Model for Individualized Propofol Dosing". The U.S. National Health and Nutrition Examination Survey of 1994 indicated that 59% of American men and 49% of women have body mass indexes (BMIs) over 25. Extreme obesity, defined as a BMI of 40 or more, was found in 2% of the men and 4% of the women \[http://www.cdc.gov/nchs/nhanes.htm\]. The new...
What is the current status of trial NCT00948597?
This trial is currently completed. The enrollment target is 26 participants. The study started on 2009-07. Estimated completion is 2013-12.
What conditions does trial NCT00948597 study?
This clinical trial studies the following conditions: Obesity, Elective Surgery.
Who is sponsoring clinical trial NCT00948597?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00948597 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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