Dexmedetomidine on Post-operative Blood Pressure in Bain Arteriovenous Malformation Embolization
6 de marzo de 2017 actualizado por: Nan Jiang
Effects of Dexmedetomidine on Post-operative Blood Pressure in Patients Undergoing Brain Arteriovenous Malformation Embolization
Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization.
The patients were randomized allocated to either Dexmedetomidine group or Control group.
Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline.
Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score, Ramsay score, and adverse events were recorded.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization.
The patients were randomized allocated to either Dexmedetomidine group or Control group according to a random number.
Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline.
Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score-15 items, Ramsay score, and adverse events were recorded.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
30
Fase
- No aplica
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
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510080
- Reclutamiento
- the First Affiliated Hospital of Sun Yetsen University
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Contacto:
- Yi Liu, Master
- Número de teléfono: +86 13632391455
- Correo electrónico: liuyisysu@126.com
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Contacto:
- Nan Jiang, professor
- Número de teléfono: +86 20 28823350
- Correo electrónico: NJiang_sysu@126.com
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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
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- patients undergoing brain arteriovenous malformation embolization in the fist affiliated hospital, Sun Yat-sen University, aged 18-65 years, available to chat with,and the tracheal tube was extubated after surgery immediately.
Exclusion Criteria:
- abuse anesthetic analgesics and sedative drugs, or allergic to Dexmedetomidine or other anesthetics, hypotension or bradycardia before surgery, severe pulmonary disease with saturation of pulse oximetry less than 90% before surgery, or patients refused to attend in this study.
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: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Dexmedetomidine
Dexmedetomidine was administered intravenously when tracheal extubation, 1.2μg/kg Dexmedetomidine was mixed with 100 ml normal saline and maintained 4 hours constantly.
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1.2 μg/kg Dexmedetomidine was administered intravenously constantly after tracheal extubation.
Otros nombres:
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Comparador de placebos: Control group
Normal Saline was administered intravenously when tracheal extubation,equal volume of normal saline was mixed with 100 ml normal saline and maintained 4 hours constantly.
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equal volume of normal saline was administered intravenously constantly after tracheal extubation.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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urapidil consumption
Periodo de tiempo: the end of the 6th hour after tracheal extubation
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urapidil consumption was recorded by nurses every hour
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the end of the 6th hour after tracheal extubation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
urapidil consumption on POD1
Periodo de tiempo: the total consumption of urapidil on post-operative day 1.
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urapidil consumption was recorded by nurses every hour
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the total consumption of urapidil on post-operative day 1.
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urapidil consumption on POD2
Periodo de tiempo: the total consumption of urapidil on post-operative day 2.
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urapidil consumption was recorded by nurses every hour
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the total consumption of urapidil on post-operative day 2.
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|
Visual Analogue score
Periodo de tiempo: the end of the 6th hour after tracheal extubation
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visual analogue score was measured by visual analogue scale
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the end of the 6th hour after tracheal extubation
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Visual Analogue score at 24th hour
Periodo de tiempo: the end of the 24th hour after tracheal extubation
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visual analogue score was measured by visual analogue scale
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the end of the 24th hour after tracheal extubation
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Visual Analogue score at 48th hour
Periodo de tiempo: the end of the 48th hour after tracheal extubation
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visual analogue score was measured by visual analogue scale
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the end of the 48th hour after tracheal extubation
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Quality of Recovery Score
Periodo de tiempo: the end of the 6th hour after tracheal extubation
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Quality of Recovery Score was measured by a 15-item quality of recovery scale
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the end of the 6th hour after tracheal extubation
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Quality of Recovery Score at 24th hour
Periodo de tiempo: the end of the 24th hour after tracheal extubation
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Quality of Recovery Score was measured by a 15-item quality of recovery scale
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the end of the 24th hour after tracheal extubation
|
|
Quality of Recovery Score at 48th hour
Periodo de tiempo: the end of the 48th hour after tracheal extubation
|
Quality of Recovery Score was measured by a 15-item quality of recovery scale
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the end of the 48th hour after tracheal extubation
|
|
Analgesics consumption
Periodo de tiempo: the end of the 6th hour after tracheal extubation
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Analgesics consumption was recorded by nurse every hour
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the end of the 6th hour after tracheal extubation
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Analgesics consumption on POD1
Periodo de tiempo: the total consumption of urapidil on post-operative day 1.
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Analgesics consumption was recorded by nurse every hour
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the total consumption of urapidil on post-operative day 1.
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Analgesics consumption on POD2
Periodo de tiempo: the total consumption of urapidil on post-operative day 2.
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Analgesics consumption was recorded by nurse every hour
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the total consumption of urapidil on post-operative day 2.
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Bradycardia
Periodo de tiempo: the end of the 6th hour after tracheal extubation
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a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
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the end of the 6th hour after tracheal extubation
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Bradycardia at 24th hour
Periodo de tiempo: the end of the 24th hour after tracheal extubation
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a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
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the end of the 24th hour after tracheal extubation
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Bradycardia at 48th hour
Periodo de tiempo: the end of the 48th hour after tracheal extubation
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a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
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the end of the 48th hour after tracheal extubation
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PONV
Periodo de tiempo: the end of the 6th hour after tracheal extubation
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post-operative nausea and vomiting (PONV) was recorded by nurse
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the end of the 6th hour after tracheal extubation
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PONV at 24th hour
Periodo de tiempo: the end of the 24th hour after tracheal extubation
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post-operative nausea and vomiting (PONV) was recorded by nurse
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the end of the 24th hour after tracheal extubation
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PONV at 48th hour
Periodo de tiempo: the end of the 48th hour after tracheal extubation
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post-operative nausea and vomiting (PONV) was recorded by nurse
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the end of the 48th hour after tracheal extubation
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Actual)
1 de enero de 2016
Finalización primaria (Anticipado)
31 de diciembre de 2017
Finalización del estudio (Anticipado)
31 de diciembre de 2017
Fechas de registro del estudio
Enviado por primera vez
6 de marzo de 2017
Primero enviado que cumplió con los criterios de control de calidad
6 de marzo de 2017
Publicado por primera vez (Actual)
9 de marzo de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de marzo de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
6 de marzo de 2017
Última verificación
1 de marzo de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Anomalías cardiovasculares
- Malformaciones Vasculares
- Anomalías congénitas
- Malformaciones arteriovenosas
- Efectos fisiológicos de las drogas
- Agentes adrenérgicos
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Analgésicos no narcóticos
- Agonistas del receptor adrenérgico alfa-2
- Agonistas alfa adrenérgicos
- Agonistas adrenérgicos
- Hipnóticos y sedantes
- Dexmedetomidina
Otros números de identificación del estudio
- NJiang2016-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
the IPD will not be shared with others, since following investigations based on this trial is about to start.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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