E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients of both sexes proposed for major abdominal surgery under general anesthesia plus epidural |
Pacientes de ambos sexos propuestos para cirugía mayor abdominal bajo anestesia general más epidural |
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E.1.1.1 | Medical condition in easily understood language |
Patients of both sexes proposed for major abdominal surgery under general anesthesia plus epidural |
Pacientes de ambos sexos propuestos para cirugía mayor abdominal bajo anestesia general más epidural |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Assess differences in the decline in forced vital capacity (FVC) among patients receiving sugammadex or neostigmine to reverse neuromuscular blockade. |
Evaluar las diferencias en el descenso en la capacidad vital forzada (CVF) entre los pacientes que reciben sugammadex o neostigmina para revertir el bloqueo neuromuscular. |
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E.2.2 | Secondary objectives of the trial |
Differences in the size of atelectasis measured by planimetry. Differences in pO2 / FiO2 ratio in the first hour after surgery. Explore the accuracy of ultrasound to detect pulmonary atelectasis and its correlation with pO2 / FiO2, chest radiography and spirometry parameters |
Diferencias en el tamaño de las atelectasias medidas por planimetría. Diferencias en la relación pO2/FiO2 en la primera hora tras la intervención. Explorar la precisión de la ecografía pulmonar para detectar atelectasias y su correlación con la pO2/FiO2, la radiografía de tórax y los parámetros espirométricos |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients who previously signed informed consent. Patients undergoing one of the following interventions: -Segmental hepatectomy, atypical or lobar. -Whipple pancreaticoduodenectomy cephalic and type reconstruction. -Pancreatic resection without reconstruction -Splenectomy. -Partial or total gastrectomy Partial or total colectomy with or without reconstruction transit |
Pacientes que firmen previamente el consentimiento informado. Pacientes sometidos a alguna de las siguientes intervenciones: -Hepatectomía segmentaria, atípica o lobar. -Duodenopancreatectomía cefálica y reconstrucción tipo Whipple. -Resecciones de páncreas sin reconstrucción -Esplenectomía. -Gastrectomía parcial o total -Colectomía total o parcial con o sin reconstrucción de tránsito |
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E.4 | Principal exclusion criteria |
? Do not give your consent. ? Come to the recovery unit mechanical ventilation. ? Have hypersensitivity reactions to any of the study drugs. ? A history of severe asthma or moderate asthma treated. ? Have a history of pulmonary fibrosis or very severe COPD (grade IV ranking GOLD). ? Have had myocardial infarction or coronary occlusion the three months prior to surgery. ? Have Myasthenia Gravis. ? Please specify emergency surgery. ? neuromuscular blockade was performed with non-steroidal blockers do not require pharmacological reversal of blockade. ? Do not have an epidural catheter for postoperative pain control. |
?No den su consentimiento. ?Lleguen a la unidad de reanimación bajo ventilación mecánica. ?Tengan reacciones de hipersensibilidad a alguna de la drogas del estudio. ?Tengan antecedentes de asma severo o asma moderado bajo tratamiento. ?Tengan antecedentes de Fibrosis pulmonar o EPOC muy severo (grado IV en la clasificación de GOLD). ?Hayan tenido infarto de miocardio u oclusión coronaria los tres meses previos a la cirugía. ?Tengan Miastenia Gravis. ?Precisen intervención quirúrgica urgente. ?Se realice el bloqueo neuromuscular con bloqueantes no esteroideos o no precisen la reversión farmacológica del bloqueo. ?No tengan un catéter epidural para el control del dolor postoperatorio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The analysis of the primary endpoint were performed with the difference between CVFb (basal) and CFV1h (the first time) and the difference between CVFb and CVF24h. (forced vital capacity at 24h). |
El análisis de la variable principal se realizará con la diferencia entre la CVFb (basal) y la CFV1h (la primera hora) y sobre la diferencia entre la CVFb y la CVF24h. (capacidad vital forzada a las 24h). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
difference between CVFb (basal) and CFV1h (the first time) and the difference between CVFb and CVF24h. (forced vital capacity at 24h). |
la diferencia entre la CVFb (basal) y la CFV1h (la primera hora) y sobre la diferencia entre la CVFb y la CVF24h. (capacidad vital forzada a las 24h). |
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E.5.2 | Secondary end point(s) |
Differences in the size of atelectasis measured by planimetry. Differences in the relationship pO2 / FiO2 in the first hour after surgery. Explore the accuracy of ultrasound to detect pulmonary atelectasis and its correlation with pO2 / FiO2, chest radiography and spirometry parameters |
Diferencias en el tamaño de las atelectasias medidas por planimetría. Diferencias en la relación pO2/FiO2 en la primera hora tras la intervención. Explorar la precisión de la ecografía pulmonar para detectar atelectasias y su correlación con la pO2/FiO2, la radiografía de tórax y los parámetros espirométricos. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Differences in the size of atelectasis measured by planimetry. Differences in the relationship pO2 / FiO2 in the first hour after surgery. Explore the accuracy of ultrasound to detect pulmonary atelectasis and its correlation with pO2 / FiO2, chest radiography and spirometry parameters |
Diferencias en el tamaño de las atelectasias medidas por planimetría. Diferencias en la relación pO2/FiO2 en la primera hora tras la intervención. Explorar la precisión de la ecografía pulmonar para detectar atelectasias y su correlación con la pO2/FiO2, la radiografía de tórax y los parámetros espirométricos. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Ciego para terceros |
blind for third person |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Date on which the last subject completed last study visit (day of discharge). |
Fecha en la que el último sujeto completa última visita del estudio (día del alta hospitalaria). |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |