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    Summary
    EudraCT Number:2013-004423-36
    Sponsor's Protocol Code Number:MK-8616-104
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-09-18
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-004423-36
    A.3Full title of the trial
    Randomized, parallel group, controlled trial to compare two different “NMB + reversal” strategies in adult obese patients underwent laparoscopic abdominal surgery (Phase 4; Protocol No. MK-8616-104-00)
    “Studio randomizzato controllato, a gruppi paralleli, per confrontare due diverse strategie di reversal del blocco neuromuscolare, in pazienti adulti obesi da sottoporre a chirurgia addominale laparoscopica”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, parallel group, controlled trial to compare two different “NMB + reversal” strategies in adult obese patients underwent laparoscopic abdominal surgery (Phase 4; Protocol No. MK-8616-104-00)
    “Studio randomizzato controllato, a gruppi paralleli, per confrontare due diverse strategie di reversal del blocco neuromuscolare, in pazienti adulti obesi da sottoporre a chirurgia addominale laparoscopica”
    A.3.2Name or abbreviated title of the trial where available
    Bridion+Esmeron vs. Neostigmina/Atropina + Nimbex in obesi (“BENN” trial)
    Studio BENN
    A.4.1Sponsor's protocol code numberMK-8616-104
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMSD Italia s.r.l.
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMSD Italia s.r.l.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation MSD Italia s.r.l
    B.5.2Functional name of contact pointDivisione Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Fratelli Cervi-Centro Direzionale Milano 2
    B.5.3.2Town/ citySegrate
    B.5.3.3Post code20090
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 02 21018402
    B.5.5Fax number+39 02 21018402
    B.5.6E-mailgcto.italy@merck.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Bridion ® 2ml SOLUZIONE INIETTABILE USO ENDOVENOSO FLACONCINO; Bridion ® 5ml SOLUZIONE INIETTABILE USO ENDOVENOSO FLACONCINO;
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBridion ®
    D.3.2Product code MK8616
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSugammadex
    D.3.9.3Other descriptive nameSUGAMMADEX
    D.3.9.4EV Substance CodeSUB26695
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number16
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Esmeron ® 10mg/ml soluzione iniettabile/per infusione
    D.2.1.1.2Name of the Marketing Authorisation holderN.V. ORGANON, Kloosterstraat 6, 5349 AB Oss (Olanda)
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEsmeron ®
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRocuronio
    D.3.9.1CAS number 119302-91-9
    D.3.9.3Other descriptive nameROCURONIUM BROMIDE
    D.3.9.4EV Substance CodeSUB10353MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Nimbex ®
    D.2.1.1.2Name of the Marketing Authorisation holderThe Wellcome Foundation Ltd. - Greenford - Gran Bretagna
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNimbex
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCISATRACURIO BESILATO
    D.3.9.1CAS number 96946-42-8
    D.3.9.3Other descriptive nameCISATRACURIUM BESILATE
    D.3.9.4EV Substance CodeSUB07480MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number0.18
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Neostigmina
    D.2.1.1.2Name of the Marketing Authorisation holderValeant Pharmaceuticals Germany GmbHDüsseldorfer Straße, 40 A
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameProstigmina
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNEOSTIGMINE
    D.3.9.1CAS number 59-99-4
    D.3.9.4EV Substance CodeSUB03411MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Atropina Solfato
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAtropina Solfato
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAtropina
    D.3.9.3Other descriptive nameATROPINE
    D.3.9.4EV Substance CodeSUB00621MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.01
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 6
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Midarine
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline S.p.A. Via A. Fleming 2 - Verona
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMidarine
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSuccinilcolina
    D.3.9.1CAS number 306-40-2
    D.3.9.4EV Substance CodeSUB08034MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Obese adults to be subjected to abdominal laparoscopic surgery
    Soggetti adulti obesi da sottoporre a chirurgia addominale laparoscopica
    E.1.1.1Medical condition in easily understood language
    Obese adults to be subjected to abdominal laparoscopic surgery
    Soggetti adulti obesi da sottoporre a chirurgia addominale laparoscopica
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary 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
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    E.4Principal 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
    E.5 End points
    E.5.1Primary 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.5.1.1Timepoint(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.5.2Secondary 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.
    E.5.2.1Timepoint(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.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Neostigmine/Atropine +Nimbex (Cisatracurio)
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned16
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    LSLV
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 178
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state178
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not available
    Non Applicabile
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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