Evaluation of Accelerometer-Based Neuromuscular Monitoring Reliability to Exclude Postoperative Residual Paralysis
Accelerometer-based neuromuscular monitoring is not the gold-standard method to evaluate residual postoperative paralysis but it represents the most simple, inexpensive and widespread tool in clinical practice. Train-of-four ratio (TOF-ratio) of 100% is considered the gold-standard to avoid PORC (post operative residual curarization).
This clinical trial is conducted to verify the reliability of accelerometer-based neuromuscular monitoring in order to exclude postoperative residual paralysis which is not highlighted by this instrument at a TOF-ratio=100%.
The study evaluates patients' neuromuscular recovery evaluated using pulmonary function tests after extubation at a TOFratio=100%. Administering placebo or sugammadex at a TOF ratio=100% allows to evaluate whether the recovery of muscle function is concrete, although the monitoring device shows a complete decurarization; patients treated with sugammadex should not be capable to perform better pulmonary function tests if a TOF ratio=100% is reliable.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
From the beginning of the surgery to the time of extubation neuromuscular block is monitored with accelerographic monitor TOF-Watch SX. Patients are extubated when TOF-ratio is 100%.
Patients will perform pulmonary function tests (PFTs):
- the day ahead of surgery (for elegibility and training)
- 60 minutes before surgery
- 10 minutes after extubation
- 5 minutes after sugammadex or placebo administration
- 20 minutes after sugammadex or placebo administration.
The following parameters will be evaluated and compared between the 2 groups:
- Maximal Inspiratory Pressure (MIP)
- Maximal Expiratory Pressure (MEP)
- Forced Expiratory Volume in the first Second (FEV1)
- Forced Vital Capacity (FVC)
- Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50)
- PaO2, PaCO2, pH
- heart rate, blood pressure and respiratory rate
Changes of pulmonary tests performed before and after sugammadex or placebo will be compared between study groups.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Milan, Italia
- Fondazione IRCCS Istituto Nazionale dei Tumori
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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:
- patients undergoing major abdominal surgery
- age between 18 and 70 years
- ASA class 1 or 2
- patients scheduled for blended anesthesia (epidural + general anesthesia)
- patients capable to perform pulmonary function tests (preoperative values of MIP, MEP, FEV1% and FEV1/FVC in normal ranges).
Exclusion Criteria:
- known or suspected respiratory, cardiovascular or neuromuscular disease
- renal or hepatic failure
- known or suspected allergies to drugs used in the study
- risk for malignant hyperthermia
- pregnancy
- diagnosed depressive disorder
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Sugamadex
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sugammadex 10 mg/ml diluted solution dosage: 1mg/kg i.v.
(0,1 ml/kg)
Otros nombres:
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Comparador de placebos: Sodium chloride solution
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Sodium chloride solution 0,9% dosage: 0,1 ml/kg i.v.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Maximum Inspiratory Pressure (MIP) changes after placebo or sugammadex
Periodo de tiempo: 10 minutes after surgery and 5 minutes later
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10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
|
10 minutes after surgery and 5 minutes later
|
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Maximum Expiratory Pressure (MEP) changes after placebo or sugammadex
Periodo de tiempo: 10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
|
10 minutes after surgery and 5 minutes later
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Forced Expiratory Volume after the first second (FEV1) changes after placebo or sugammadex
Periodo de tiempo: 10 minutes after surgery and 5 minutes later
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10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
|
10 minutes after surgery and 5 minutes later
|
|
Forced Vital Capacity (FVC) changes after placebo or sugammadex
Periodo de tiempo: 10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
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10 minutes after surgery and 5 minutes later
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50) changes after placebo or sugammadex
Periodo de tiempo: 10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
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10 minutes after surgery and 5 minutes later
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Hemogasanalysis parameters changes after placebo or sugammadex
Periodo de tiempo: 10 minutes after surgery and 5 minutes later
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10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
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10 minutes after surgery and 5 minutes later
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Swallow ability changes after placebo or sugammadex
Periodo de tiempo: 10 minutes after surgery and 5 minutes later
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10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
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10 minutes after surgery and 5 minutes later
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Colaboradores e Investigadores
Investigadores
- Director de estudio: Federico Piccioni, MD, Fondazione IRCCS Istituto Nazionale dei tumori - Milan
Publicaciones y enlaces útiles
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
- INT-66/11
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