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- Ensayo clínico NCT01809886
Reversal With Sugammadex From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial (SUGAPED-01)
Reversal With Sugammadex (BRIDION ®) From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial of Efficacy and Safety
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Muscle relaxing facilitates endotracheal intubation and surgical access. Muscle relaxants have a long duration with the possibility of residual muscle relaxation after surgery (over 40% of patients), and ventilatory problems (hypoxia, hypercapnia, atelectasis, airway collapse) that raise postoperative morbidity and mortality.
All of these facts are accentuated in the pediatric patient due to the reduced airway caliber which tends lead to obstruction and bronchospasm. So far, the effect of muscle relaxants has only been partially reversed by anticholinesterase (neostigmine), which has the limitation of its short duration of action (8-9 minutes) and has many side effects (bradycardia, hypotension, increased salivation, vomiting, dyspnea and bronchoconstriction). It also needs to be combined with anticholinergic (atropine), which causes a dry mouth, blurred vision and tachycardia.
At present, the introduction of sugammadex (Bridion®), an antagonist of nondepolarizing the neuromuscular relaxant rocuronium, may lead to an extraordinary breakthrough. It is the only antagonist able to encapsulate and fully eliminate the muscle relaxant to avoid residual effects and respiratory complications. Muscle strength can be retrieved at any time, without waiting for relaxant metabolism (30 to 40 minutes) and without using the usual classical antidotes (neostigmine and atropine), which produce many undesirable effects that become more troublesome in the postoperatory phase. Sugammadex lacks intrinsic activity and is considered safe, without significant side effects and can be used in cardiovascular or respiratory diseases.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Murcia
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El Palmar, Murcia, España, 30120
- Mª Dolores Cárceles Barón
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Children of both sexes,
- Aged between two and eleven years who have undergone surgery for procedures of short duration (less than one hour) and requiring muscle relaxation.
- Informed consent signed by parents or guardians
Exclusion Criteria:
- No signed informed consent by parent/guardian,
- Anticipated difficult airway,
- Neuromuscular disease,
- Liver and/or renal failure,
- Personal or family history of malignant hyperthermia,
- Previous allergic reaction to any anesthetic.
- Treated at the time of the study with aminoglycosides, magnesium, or anticonvulsants.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Sugammadex
50 patients, aged between 2 and 11 years scheduled for surgery and requiring muscle relaxation.
The reversal will be made with sugammadex 4 mg/kg when surgery is over, maintaining a profound block level until that point in time (no response to TOF and PTC<2).
|
50 patients, aged between 2 and 11 years scheduled for surgery and requiring muscle relaxation.
The reversal will be made with sugammadex 4 mg/kg when surgery is over, maintaining a profound block level until that point in time (no response to TOF and PTC<2).
|
|
Comparador activo: Neostigmina
50 patients aged between 2 and 11 years scheduled for surgery and requiring muscle relaxation.
The reversal will be made with neostigmine 0. 05 mg/kg and atropine 0.025 mg/kg (conventional reverser treatment) when surgery is over, maintaining a profound block level unit that point in time (no response to TOF and PTC<2).
|
50 patients aged between 2 and 11 years scheduled for surgery and requiring muscle relaxation.
The reversal will be made with neostigmine 0. 05 mg/kg and atropine 0.025 mg/kg (conventional reverser treatment) when surgery is over, maintaining a profound block level unit that point in time (no response to TOF and PTC<2).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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The time in seconds which has elapsed until a T4/T1 ratio >0,9.
Periodo de tiempo: After surgery (Up to 10 h)
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After surgery (Up to 10 h)
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Heart Rate (beats / min)
Periodo de tiempo: After surgery (Up to 10 h)
|
After surgery (Up to 10 h)
|
|
Systolic and Diastolic blood pressure (mm HG)
Periodo de tiempo: After surgery (up to 10 h)
|
After surgery (up to 10 h)
|
|
Arterial oxygen saturation (%)
Periodo de tiempo: After surgery (up to 10 h)
|
After surgery (up to 10 h)
|
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Total dose of rocuronium (mg/kg)
Periodo de tiempo: After surgery (up to 10 h)
|
After surgery (up to 10 h)
|
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Number of participants with at least One Adverse event (AE)
Periodo de tiempo: up to 24 h
|
up to 24 h
|
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Time in seconds from the initial dose administered of rocuronium until the maximum block is achieved(Onset time)
Periodo de tiempo: During peri-anesthetic period (up to 10 h)
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During peri-anesthetic period (up to 10 h)
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|
The time in seconds which has elapsed until a T4/T1 >0,8 is achieved.
Periodo de tiempo: After surgery (up to 10 h)
|
After surgery (up to 10 h)
|
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The time in seconds which has elapsed until a T4/T1 ratio >0,7
Periodo de tiempo: After surgery (up to 10 h)
|
After surgery (up to 10 h)
|
Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: MºDolores Cárceles Barón, MD,PhD, Hospital Universitario Virgen de la Arrixaca
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CT-PED-2010-01CT
- 2011-000401-50 (Número EudraCT)
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