Propofol in Obese Children

Propofol in Obese Children

Patrocinadores

Patrocinador principal: Baylor College of Medicine

Fuente Baylor College of Medicine
Resumen breve

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.

Estado general Unknown status
Fecha de inicio April 2008
Fecha de Terminación December 2010
Fecha de finalización primaria November 2010
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Loss of consciousness 20 seconds
Resultado secundario
Medida Periodo de tiempo
Depth of sedation 2 minutes
Inscripción 80
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Propofol

Descripción: 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)

Etiqueta de grupo de brazo: Obese children

Otro nombre: Diprivan

Tipo de intervención: Drug

Nombre de intervención: Propofol

Descripción: 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)

Etiqueta de grupo de brazo: Non-obese

Otro nombre: Diprivan

Elegibilidad

Criterios:

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 -

Género: All

Edad mínima: 3 Years

Edad máxima: 17 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Olutoyin A Olutoye, MD Principal Investigator Baylor College of Medicine
Contacto general

Apellido: Olutoyin A Olutoye, M.D

Teléfono: 832-824-5800

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Copia de seguridad de contactos: Investigador: Texas Children's Hospital, Baylor College of Medicine Olutoyin A Olutoye, MD 832-824-5800 [email protected] Olutoyin A Olutoye, MD Principal Investigator
Ubicacion Paises

United States

Fecha de verificación

November 2010

Fiesta responsable

Nombre Titulo: Olutoyin Olutoye M.D/Associate Professor of Anesthesiology & Pediatrics

Organización: Baylor College of Medicine

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Non-obese

Tipo: Other

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

Etiqueta: Obese children

Tipo: Active Comparator

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

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Single (Participant)

Fuente: ClinicalTrials.gov