| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Obese adults to be subjected to abdominal laparoscopic surgery |
| Soggetti adulti obesi da sottoporre a chirurgia addominale laparoscopica |
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| E.1.1.1 | Medical condition in easily understood language |
| Obese adults to be subjected to abdominal laparoscopic surgery |
| Soggetti adulti obesi da sottoporre a chirurgia addominale laparoscopica |
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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 primary objective of this study is to compare the preference between the two strategies and reversal of neuromuscular blockade in obese adults to be subjected to abdominal laparoscopic surgery. This will be done by evaluating the average of the scores obtained by the VNS surgeons blinded to the drugs administered. |
| L’obiettivo primario di questo studio è quello di confrontare la preferenza tra due strategie di blocco neuromuscolare e reversal, in pazienti obesi adulti da sottoporre a chirurgia addominale laparoscopica. Questo avverrà valutando la media dei punteggi VNS ottenuti dai chirurghi in cieco rispetto ai farmaci somministrati. |
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| E.2.2 | Secondary objectives of the trial |
The main secondary objectives of the study are to compare between the two groups,
(1) the time between the end of surgery and the time to extubation,
(2) The time that elapses between administration of the reversal and the TOFR> 0.9 |
I principali obiettivi secondari dello studio sono di confrontare tra i due gruppi,
(1) il tempo tra la fine della chirurgia e il tempo di estubazione,
(2) Il tempo che intercorre tra la somministrazione del reversal e il TOFr>0,9
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
The patient should be obese, defined as Body Mass Index ≥30.0
The patient should be scheduled for elective laparoscopic abdominal surgery with general anesthesia
The patient should be classified as ASA Class 1, 2, or 3
The patient should be able to understand the questionnaires in order to give reliable answers
The patient must have an arm accessible during surgery for the monitoring of the block with the TOF Watch SX® that will be used for the purpose of monitoring neuro-muscular transmission
The patient should have the results of laboratory tests (CBC, biochemistry) within normal limits or clinically acceptable to the investigator / sponsor
The patient must have the results of the physical examination, including blood pressure within normal limits or clinically acceptable to the investigator / sponsor |
Il paziente deve essere obeso, definito come Body Mass Index ≥30.0
Il paziente deve essere pianificato per chirurgia addominale laparoscopica elettiva con anestesia generale
Il paziente deve essere categorizzato come ASA Class 1, 2, o 3
Il paziente deve essere capace di capire i questionari per poter dare risposte attendibili
Il paziente deve avere un braccio accessibile durante l’intervento per il monitoraggio del blocco con il TOF Watch SX® che sarà usato per il monitoraggio obiettivo della trasmissione neuro-muscolare
Il paziente deve avere i risultati dei test di laboratorio (CBC, biochimica) entro i limiti normali o clinicamente accettabili per lo sperimentatore/lo sponsor
Il paziente deve avere i risultati del esame fisico, inclusa la pressione sanguinea, entro i limiti normali o clinicamente accettabili per lo sperimentatore/lo sponsor
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| E.4 | Principal exclusion criteria |
The patient malformations that could embarrass the intubation
The patient has neuromuscular disorders that can affect the neuro-muscular blocking and / or assessments of the study
The patient has already made other abdominal laparoscopic procedures
The patient has no history of chronic pain, defined as opioids or NSAIDs within 7 days before surgery
Female patients of childbearing age who have given birth in the previous 12 months or are pregnant or plan to become pregnant between randomization and the contact of Day 30 pregnancy follow-up
The patient has evidence of acute cholecystitis
The patient dialysis-dependent renal failure or has suspected severe renal impairment (defined as estimated creatinine clearance <30 mL / min).
significant hepatic dysfunction, which may prevent the patient to participate in the study by the investigator based on the RCP of the study drugs
The patient has a history or family history of malignant hypothermia
The patient has a known allergy to the study treatments or their ingredients, opioids / opiates, or other medicines used during general anesthesia
Transfer UCI after surgery
The patient received one of the treatments in Table 1, more recently, by the period of wash-out
The patient should continue taking during the study one of the treatments listed in Table 1 |
Il paziente ha malformazioni che possano mettere in difficoltà la intubazione
Il paziente ha disturbi neuromuscolari che possano avere effetto sul blocco neuro-muscolare e/o le valutazioni dello studio
Il paziente ha già fatto altre procedure addominali laparoscopiche
Il paziente ha storia di dolore cronico, definito come assunzione di oppioidi o FANS nei 7 giorni prima della chirurgia
Pazienti di sesso femminile in età fertile che hanno partorito nei 12 mesi precedenti o sono incinte o pensano di rimanere incinte tra la randomizzazione e il contatto di Day 30 pregnancy follow-up
Il paziente ha evidenze di colecistite acuta
Il paziente ha insufficienza renale dipendente dalla dialisi o ha sospetta insufficienza renale severa (definita come clearance della creatinina stimato < 30 mL/min).
Disfunzione epatica significativa che può impedire al paziente di partecipare nello studio secondo lo sperimentatore basandosi sulla RCP dei farmaci in studio
Il paziente ha anamnesi o anamnesi familiare di ipotermia maligna
Il paziente ha allergia nota ai trattamenti in studio o i loro eccipienti, oppiodi/oppiacei, o altri medicinali usati durante la anestesia generale
Trasferimento in UCI dopo l’intervento
Il paziente ha ricevuto uno dei trattamenti in Tabella 1 più recentemente dal periodo di wash-out
Il paziente deve continuare a prendere durante lo studio uno dei trattamenti elencati in Tabella 1
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|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary objective of this study is to compare the preference between the two strategies and reversal of neuromuscular blockade in obese adults to be subjected to abdominal laparoscopic surgery. This will be done by evaluating the average of the scores obtained by the VNS surgeons blinded to the drugs administered. |
| ’obiettivo primario di questo studio è quello di confrontare la preferenza tra due strategie di blocco neuromuscolare e reversal, in pazienti obesi adulti da sottoporre a chirurgia addominale laparoscopica. Questo avverrà valutando la media dei punteggi VNS ottenuti dai chirurghi in cieco rispetto ai farmaci somministrati. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Detection time will be at the end of surgery |
| Il tempo di rilevazione sarà alla fine dell’intervento chirurgico |
|
| E.5.2 | Secondary end point(s) |
(1) the time between the end of surgery and the time to extubation,
(2) The time that elapses between administration of the reversal and the TOFr≥0.9.
Other secondary efficacy endpoints are
(1) The total time of use of the operating room compared between the two groups;
(2) a comparison of the time-point between the two groups in the average value of the preference of patients, collected by QoR score;
(3) comparison between the groups of a "comprehensive anesthesia score" average, to be collected by the anesthetist when the patient leaves the PACU (if available) or the operating room, consisting of answers to some questions relating to the management and events occurred during the procedure; (4) comparison between groups of time to achieve a modified Aldrete score> 9 in two successive assessments prior to discharge from the PACU (if available) or from the operating room. |
(1) il tempo tra la fine della chirurgia e il tempo di estubazione,
(2) Il tempo che intercorre tra la somministrazione del reversal e il TOFr≥0.9.
Altri endpoint secondari di efficacia sono
(1) il tempo totale di utilizzo della sala operatoria in confronto tra i due gruppi;
(2) il confronto del time-point tra i due gruppi del valore medio della preferenza dei pazienti, raccolti mediante punteggio QoR;
(3) confronto tra i gruppi di un “comprehensive anesthesia score” medio, da raccogliere da parte dell’anestesista quando il paziente lascia la PACU (se disponibile) oppure la sala operatoria, composta da risposte ad alcune domande relative alla gestione e agli eventi verificatisi durante la procedura; (4) confronto tra i gruppi del tempo per raggiungere un punteggio di Aldrete modificato >9 in due valutazioni successive prima della dimissione dalla PACU (se disponibile) o dalla sala operatoria.
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| The detection time is between the end of surgery and discharge from the PACU operating room. |
| Il tempo di rilevazione è compreso tra la fine dell’intervento e la dimissione dalla PACU i sala operatoria. |
|
| 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 | Yes |
| 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 | Yes |
| E.8.2.3.1 | Comparator description |
| Neostigmine/Atropine +Nimbex (Cisatracurio) |
|
| 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 | 16 |
| 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
|
|
| 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 | 0 |
| 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 | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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