E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neuromuscular block is commonly adopted during general anesthesia to facilitate tracheal intubation, mechanical ventilation and surgical manipulation. At the end of anesthesia it very important to avoid residual neuromuscular block to ensure adequate respiratory function preventing postoperative pulmonary complications. This trial compares the neuromuscular block reversal with different drugs (sugammadex vs neostigmine) after thoracic anesthesia. |
Il blocco neuromuscolare è adottato in corso di anestesia generale per facilitare l'intubazione tracheale, la ventilazione meccanica e la manipolazione chirurgica. Al termine dell'anestesia è importante evitare la paralisi muscolare residua per garantire un'adeguata funzione respiratoria al paziente e ridurre il rischio di complicanze respiratorie postoperatorie. Lo studio confronta due antagonisti per il blocco neuromuscolare da rocuronio (sugammadex vs neostigmina) dopo anestesia toracica. |
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E.1.1.1 | Medical condition in easily understood language |
This study compares the efficacy of two drugs (sugammadex vs neostigmine) as reversal of muscular paralysis due to neuromuscular blocking agents administered during thoracic anesthesia. |
Lo studio compara due farmaci (sugammadex vs neostigmina) nell'antagonizzare la paralisi muscolare indotta da farmaci paralizzanti durante anestesia toracica. |
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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 |
The trial main objective is to demonstrate that sugammadex is faster than neostigmine to reach a TOF-ratio of 0.9 after thoracic anesthesia. TOF-ratio is defined as the ratio of the fourth muscular twitch/first twitch value during an accelerometric train-of-four stimulation. |
Dimostrare che sugammadex è più rapido della neostigmina nel favorire il raggiungimento di un TOF-ratio di 0.9 dopo anestesia toracica. Il TOF-ratio è definito come il rapporto tra l'intensità della quarta contrazione muscolare e la prima contrazione durante un treno di quattro stimoli mediante monitoraggio neuromuscolare accelerometrico. |
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E.2.2 | Secondary objectives of the trial |
Demonstrate that sugammadex allows a faster extubation. Verify if there is a difference between sugammadex and neostigmine as regards adverse events after extubation and in the postoperative period (until the 30th day after surgery). |
Dimostrare che sugammadex abbrevia il tempo necessario per l'estubazione dei pazienti. Verificare se vi sia una differenza tra sugammadex e neostigmina in termini di incidenza di eventi avversi dopo l'estubazione e fino al 30mo giorno dopo l'intervento. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subjects scheduled for pulmonary resection, lebectomy, pneumonectomy, bullectomy, pleurodesis - Age 18-70 years - ASA class 1,2,3 - Body Mass Index (BMI) 18-30 kg/m2 |
- Pazienti sottoposti a resezione polmonare, lobectomia, pneumonectomia, bullectomia, pleurodesi - Età 18-70 anni - Classe ASA 1,2,3 - Body Mass Index (BMI) 18-30 kg/m2
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E.4 | Principal exclusion criteria |
- Subject scheduled for esofagectomy, thoracectomy, vascular resection - COPD Gold class III and IV, respiratory infection, asthma - Preoperative FEV1 < 60% of predicted, FEV1/FVC<70% - Preoperative DLCO2/VA<60% of predicted - Preoperative SpO2<92%, PaO2/FiO2<300 - Cardiovascular desease with a METS score less than 4 - Neuromuscular disorder - Kidney insufficiency (eGFR<30 ml/min/1,73m2) - Pregnant women
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- pazienti sottoposti a esofagectomia, toracectomia, resezioni vascolari - BPCO Gold class III and IV, infezioni respiratorie, asma bronchiale - FEV1 preoperatorio < 60% del teorico, FEV1/FVC<70% - DLCO2/VA preoperatorio < 60% del teorico - SpO2 preoperatorio <92%, PaO2/FiO2<300 - Patologie cardiovascolari con METS score < 4 - Patologie neuromuscolari - Insufficienza renale (eGFR<30 ml/min/1,73m2) - Donne in stato di gravidanza |
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E.5 End points |
E.5.1 | Primary end point(s) |
Time from reversal administration to TOF-ratio = 0.9
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Tempo dalla somministrazione del farmaco decurarizzante al raggiungimento di un TOF-ratio=0.9 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of general anesthesia |
A fine anestesia |
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E.5.2 | Secondary end point(s) |
Time from reversal administration to TOF-ratio = 1.0 Time from reversal administration to extubation Adverse events and side effects incidence after extubation and in the postoperative period (until the 30th day after surgery) |
Tempo dalla somministrazione del farmaco decurarizzante al raggiungimento di un TOF-ratio=1.0 Tempo dalla somministrazione del farmaco decurarizzante all'estubazione Incidenza di eventi avversi ed effetti collaterali dopo l'estubazione e fino a 30 giorni dopo l'intervento chirurgico |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the end of general anesthesia (time to extubation) Adverse events and side effects will be evaluated in the first 60 minutes after extubation, in the first 5 days after operation and at 30 days after surgery. |
Alla fine dell'anestesia (tempo per l'estubazione). Gli eventi avversi e gli effetti collaterali saranno valutati nella prima ora dopo l'estubazione, nei primi 5 giorni dopo l'intervento e a 30 giorni dalla chirurgia. |
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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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
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
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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |