Propofol in Obese Children

NCT01242241 | Completed Phase 3 Results FDA Drug

• 1 other identifier: H-22091
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacodynamics; Obesity

Keywords

Propofol; Childhood obesity; Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Dose of Propofol That Caused Loss of Consciousness in 95% (ED95) of Obese and Non-obese Children

  Propofol is administered over 10 seconds. 20 seconds after adminstration, loss of consciousness is assessed by the presence or absence of a lash reflex. The dose responsible for loss of lash reflex/consciousness in 95% of patients was determined in mg/kg.

  20 seconds

Secondary Outcomes (1)

• Depth of Sedation

  30 seconds, 1 minute, and 2 minutes

Study Arms (2)

Non-obese

OTHER

Non-obese children categorized as those with a body mass index(BMI)between 25-84th percentile

Drug: Propofol

Obese children

ACTIVE COMPARATOR

Obese children are categorized as those with a body mass index \>95th percentile

Drug: Propofol

Interventions

Propofol DRUG

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)

Also known as: Diprivan

Obese children

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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-

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital, Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Pace NL, Stylianou MP. Advances in and limitations of up-and-down methodology: a precis of clinical use, study design, and dose estimation in anesthesia research. Anesthesiology. 2007 Jul;107(1):144-52. doi: 10.1097/01.anes.0000267514.42592.2a.

  PMID: 17585226 BACKGROUND

• 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.

  PMID: 20585055 BACKGROUND

MeSH Terms

Conditions

Obesity; Pediatric Obesity

Interventions

Propofol

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Olutoyin A. Olutoye
• Organization: Baylor College of Medicine

oao@bcm.edu

832-824-5800

Study Officials

• Olutoyin A Olutoye, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professorof Anesthesiology & Pediatrics

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 16, 2010
• Study Start: April 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 21, 2020
• Results First Posted: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)