Status:
COMPLETED
Development of PK/PD Model for Individualized Propofol Dosing
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Obesity
Elective Surgery
Eligibility:
All Genders
5-18 years
Brief 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 ...
Detailed Description
STUDY OBJECTIVES Hypothesis: The inter-patient variability in propofol effects in relation to clinical response and adverse events in morbidly obese adolescents is associated with identifiable pharmac...
Eligibility Criteria
Inclusion
- Age 5 to 18 years of age;
- Have a Body Mass Index (BMI) greater than 30;
- Be scheduled for bariatric or other elective surgical procedure;
- Will be administered propofol anesthesia as part of procedure and standard of care and subject is expected to be under anesthesia for at least 60 minutes;
- Signed and dated IRB-approved Informed Consent or Parental Permission and Assent form, as applicable.
Exclusion
- Patients receiving investigational agent as part of another clinical study;
- Patients with severe developmental delay, known neurological disorders;
- Conditions where the placement of the sensor or process of assessment could interfere with the BIS monitoring;
- Allergy to propofol / anaphylaxis to egg protein;
- History of severe sleep apnea;
- Anticipated difficult airway access;
- Significant allergies and sensitivities to tape and/or adhesives.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00948597
Start Date
July 1 2009
End Date
December 1 2013
Last Update
January 9 2014
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229