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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

The purpose of this clinical trial is to prove that the administration of sugammadex at a dose of 4 mg/kg for counteracting deep blockage [without train-of-four (TOF) ratio response and post-tetanic count (PTC) < of 2 induced and maintained with Rocuronium in pediatric patients for short-term elective surgery.

Descripción general del estudio

Estado

Terminado

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

Intervencionista

Inscripción (Actual)

100

Fase

  • Fase 3

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

    • Murcia
      • El Palmar, Murcia, España, 30120
        • Mª Dolores Cárceles Barón

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

2 años a 11 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

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

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: 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
The time in seconds which has elapsed until a T4/T1 ratio >0,9.
Periodo de tiempo: After surgery (Up to 10 h)
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)
Total dose of rocuronium (mg/kg)
Periodo de tiempo: After surgery (up to 10 h)
After surgery (up to 10 h)
Number of participants with at least One Adverse event (AE)
Periodo de tiempo: up to 24 h
up to 24 h
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)
During peri-anesthetic period (up to 10 h)
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)
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

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

Investigadores

  • Investigador principal: MºDolores Cárceles Barón, MD,PhD, Hospital Universitario Virgen de la Arrixaca

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 octubre de 2011

Finalización primaria (Actual)

1 de octubre de 2013

Finalización del estudio (Actual)

1 de diciembre de 2013

Fechas de registro del estudio

Enviado por primera vez

28 de agosto de 2012

Primero enviado que cumplió con los criterios de control de calidad

11 de marzo de 2013

Publicado por primera vez (Estimar)

13 de marzo de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

6 de marzo de 2014

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

5 de marzo de 2014

Última verificación

1 de marzo de 2014

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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