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Dexmedetomidine in Children Having Transthoracic Echocardiography

28 de julio de 2017 actualizado por: Children's Hospital Medical Center, Cincinnati

A Qualitative Comparison of Oral Chloral Hydrate vs 2.0 or 3.0 mcg/kg Nasal Dexmedetomidine in Children Undergoing Transthoracic Echocardiography

Sedation Techniques for children undergoing transthoracic echocardiography (TTE).

Descripción general del estudio

Descripción detallada

The goal in this study is to determine if there is a significant difference in the quality of sedation between two standard sedation techniques and between two doses of dexmedetomidine for children undergoing (TTE).

Tipo de estudio

Intervencionista

Inscripción (Actual)

279

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Shanghai, Porcelana
        • Shanghai Children's Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

3 meses a 3 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Outpatients scheduled to receive sedation for transthoracic echocardiography
  • Subject must be a candidate for both types of anesthetic and both doses of dexmedetomidine
  • Must be 3 months to 36 months of age

Exclusion Criteria:

  • The subject has a history of cardiac conduction system disease (e.g. 1st or 2nd degree AV block) or channelopathy (e.g. long QT).
  • The subject is taking digoxin, alpha-adrenergic or beta-adrenergic agonist or antagonist (e.g., clonidine, propranolol, albuterol), anti-arrhythmic medications, or vasodilators (e.g. ACE inhibitors)
  • The subject has received a dose of any other sedative within 48 hours.
  • The subject has life-threatening, medical conditions (American Society of Anesthesiologists Physical Status 4, 5). The American Society of Anesthesiologists (ASA) classification scale is a measure of physical status or how healthy the patient is. For our study, we will focus on children which are defined as ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease that is mild and well controlled (ASA II) or a child with systemic disease that is severe and controlled (ASA III).
  • The subject is allergic to or has a contraindication to any of the drugs used in the study.
  • The subject has previously been treated under this protocol.
  • The subject has severe coarctation of the aorta (risk of exaggerated vasoconstriction)
  • The subject has Moyamoya disease (risk of recurrent stroke)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Chloral Hydrate + placebo
Oral chloral hydrate sedation in flavored syrup plus nasal saline placebo
70mg/kg chloral hydrate
Flavored placebo syrup
Comparador activo: Dexmedetomidine 2mcg/kg + placebo
Nasal dexmedetomidine sedation 2 mcg/kg plus oral flavored syrup placebo
Flavored placebo syrup
2mcg/kg
3mcg/kg
Comparador activo: Dexmedetomidine 3mcg/kg + placebo
Nasal dexmedetomidine sedation 3 mcg/kg plus oral flavored syrup placebo
Flavored placebo syrup
2mcg/kg
3mcg/kg

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to sedation
Periodo de tiempo: 30 minutes
Achieve Ramsay sedation >3 within 30 minutes of administration of drug
30 minutes

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Duration of sedation level >3
Periodo de tiempo: Patients will be followed for the duration of the procedure, average of 1 hour
Patients will be followed for the duration of the procedure, average of 1 hour
The number of sonographer pauses
Periodo de tiempo: Participants will be followed for the duration of the procedure, average of 1 hour
The number of sonographer pauses over 2 minutes due to patient movement or medical interventions will be counted
Participants will be followed for the duration of the procedure, average of 1 hour
Need for rescue dexmedetomidine
Periodo de tiempo: Participants will be followed for the duration of the procedure, average of 1 hour
The incidence of need for rescue nasal dexmedetomidine, due to patient arousal or movement prior to completion of TTE.
Participants will be followed for the duration of the procedure, average of 1 hour
Incidence of respiratory complications
Periodo de tiempo: Participants will be followed for the duration of the hospital stay, average of 2 hours
Documentation of the incidence of respiratory complications
Participants will be followed for the duration of the hospital stay, average of 2 hours
Vital sign deviations of more than 30% from baseline
Periodo de tiempo: Participants will be followed for the duration of the hospital stay, average of 2 hours
Documentation of the incidence of blood pressure or heart rate deviations of more than 30% from baseline. Baseline will be measured prior to sedative administration.
Participants will be followed for the duration of the hospital stay, average of 2 hours
Post anesthesia drowsiness
Periodo de tiempo: Participants will be followed for the duration of the post procedure stay, average of 1 hour
Documentation of the incidence of post anesthesia drowsiness
Participants will be followed for the duration of the post procedure stay, average of 1 hour
Duration of Post Anesthesia Care Unit phase
Periodo de tiempo: Participants will be followed for the duration of the post procedure stay, average of 1 hour
Documentation of the stay in Post Anesthesia Care Unit in minutes
Participants will be followed for the duration of the post procedure stay, average of 1 hour
Time to oral fluid intake
Periodo de tiempo: Participants will be followed for the duration of the post procedure stay, average of 1 hour
Documentation of the time (in minutes) to oral fluid intake during the PACU phase
Participants will be followed for the duration of the post procedure stay, average of 1 hour
Time to discharge
Periodo de tiempo: Participants will be followed for the duration of the post procedure stay, average of 1 hour
Documentation of the hospital stay after completion of the TTE.
Participants will be followed for the duration of the post procedure stay, average of 1 hour
Satisfaction of parents
Periodo de tiempo: Up to 3 days
The satisfaction of the sedation technique will be completed by the parents by asking a series of questions during a follow-up phone call the next business day after the TTE.
Up to 3 days
Severity of respiratory complications
Periodo de tiempo: Participants will be followed for the duration of the hospital stay, average of 2 hours
Documentation of the severity of respiratory complications
Participants will be followed for the duration of the hospital stay, average of 2 hours
Post anesthesia agitation
Periodo de tiempo: Participants will be followed for the duration of the post procedure stay, average of 1 hour
Documentation of the incidence of post anesthesia agitation
Participants will be followed for the duration of the post procedure stay, average of 1 hour

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Jeffrey Miller, MD, Children's Hospital Medical Center, Cincinnati

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2014

Finalización primaria (Actual)

1 de mayo de 2017

Finalización del estudio (Actual)

1 de mayo de 2017

Fechas de registro del estudio

Enviado por primera vez

27 de julio de 2015

Primero enviado que cumplió con los criterios de control de calidad

13 de agosto de 2015

Publicado por primera vez (Estimar)

14 de agosto de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

31 de julio de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

28 de julio de 2017

Última verificación

1 de julio de 2017

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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