Propofol in Obese Children
Propofol in Obese Children
Sponsors
Source
Baylor College of Medicine
Oversight Info
Has Dmc
No
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 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.
Overall Status
Unknown status
Start Date
2008-04-01
Completion Date
2010-12-01
Primary Completion Date
2010-11-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Loss of consciousness |
20 seconds |
Secondary Outcome
Measure |
Time Frame |
|
Depth of sedation |
2 minutes |
Enrollment
80
Conditions
Intervention
Intervention Type
Drug
Intervention Name
Description
Each Obese child/subject in this group will receive a predetermined dose of propofol ranging from 1.0mg/kg to 4.25mg/kg to induce loss of consciousness depending on the response (presence or absence of lash reflex) of the preceding patient to his/her assigned dose (biased coin design)
Arm Group Label
Obese children
Other Name
Diprivan
Intervention Type
Drug
Intervention Name
Description
This arm of patients(non-obese)will act as the control group for the obese children. Each non-obese child/subject will receive a predetermined dose of propofol from a range of 1.0mg/kg to 4.25mg/kg depending on the response of the previous patient to their assigned dose( biased coin design)
Arm Group Label
Non-obese
Other Name
Diprivan
Eligibility
Criteria
Inclusion Criteria:
1. 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)
2. American Society of Anesthesiology(ASA) classification 1 or 2-
Exclusion Criteria:
1. Patients classified as ASA (American Society of Anesthesiology) Class 3 or greater.
2. Patients with documented kidney or liver disease or those presenting for open surgery
on the liver or kidney.
3. Patients who will NOT be receiving propofol for induction as part of their anesthetic
regimen.
4. Patients who are currently on anti-convulsant medication or receiving drugs with
sedative effects.
5. Patients currently being treated for attention deficit disorder.
6. Patients who are diagnosed with failure to thrive or those with a BMI less than 25th
percentile.
7. Patients who are hemodynamically unstable.
8. Patients with egg allergy.
9. Patients with low levels of albumin -
Gender
All
Minimum Age
3 Years
Maximum Age
17 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Olutoyin A Olutoye, MD |
Principal Investigator |
Baylor College of Medicine |
Overall Contact
Location
Facility |
Status |
Contact |
Investigator |
|
Texas Children's Hospital, Baylor College of Medicine Houston Texas 77030 United States |
Recruiting |
Last Name: Olutoyin A Olutoye, MD Role: Principal Investigator |
Location Countries
Country
United States
Verification Date
2010-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Name Title
Olutoyin Olutoye M.D/Associate Professor of Anesthesiology & Pediatrics
Organization
Baylor College of Medicine
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Propofol
Arm Group
Arm Group Label
Non-obese
Arm Group Type
Other
Description
Non-obese children categorized as those with a body mass index(BMI)between 25-84th percentile
Arm Group Label
Obese children
Arm Group Type
Active Comparator
Description
Obese children are categorized as those with a body mass index >95th percentile
Firstreceived Results Date
N/A
Overall Contact Backup
Reference
Citation
Pace NL, Stylianou MP. Advances in and limitations of up-and-down methodology: a précis of clinical use, study design, and dose estimation in anesthesia research. Anesthesiology. 2007 Jul;107(1):144-52. Review.
PMID
17585226
Citation
Mulla H, Johnson TN. Dosing dilemmas in obese children. Arch Dis Child Educ Pract Ed. 2010 Aug;95(4):112-7. doi: 10.1136/adc.2009.163055. Epub 2010 Jun 28. Review.
PMID
20585055
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)
Study First Submitted
November 15, 2010
Study First Submitted Qc
November 15, 2010
Study First Posted
November 16, 2010
Last Update Submitted
November 15, 2010
Last Update Submitted Qc
November 15, 2010
Last Update Posted
November 16, 2010
Last Known Status
Recruiting
Pending Results
Submitted
January 26, 2015
May 11, 2016
Returned
February 9, 2015
June 16, 2016
ClinicalTrials.gov processed this data on December 06, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.