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    Summary
    EudraCT Number:2017-003623-29
    Sponsor's Protocol Code Number:63227.091.17
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-12-06
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-003623-29
    A.3Full title of the trial
    MRI measurement of the effects of moderate versus deep neuromuscular blockade on the abdominal working space during laparoscopic surgery in a prospective cohort study.
    Het effect van standaard versus diepe spierverslapping op het chirurgisch werkveld tijdens laparoscopische ingrepen, gemeten middels MRI in een
    prospectieve cohort studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effects of deep muscle relaxation on the surgical conditions during laparoscopy
    Het effect van diepe spierverslapping op de chirurgische werkomstandigheden tijdens kijkoperaties
    A.3.2Name or abbreviated title of the trial where available
    RELAX-2 study
    RELAX-2 studie
    A.4.1Sponsor's protocol code number63227.091.17
    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 SponsorRadboudumc
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Sharp & Dohme BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboudumc
    B.5.2Functional name of contact pointRELAX-2 information
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein Zuid 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31243617612
    B.5.6E-mailMoira.Bruintjes@radboudumc.nl
    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 Esmeron (Rocuroniumbromide)
    D.2.1.1.2Name of the Marketing Authorisation holderNV Organon
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Bridion
    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.3.4Pharmaceutical form Solution for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Mivacron
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma Trading Limited
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    We will investigate the effect of deep neuromuscular blockade on the abdominal working space. We will include patients undergoing laparoscopic surgery, including laparoscopic donor nephrectomy, laparascopic cholecystectomy and laparoscopic colectomy.
    Wij onderzoeken het effect van diepe spierverslapping op de chirurgische werkruimte tijdens laparoscopische operaties, waaronder laparoscopische donornefrectomie, laparoscopische cholecystectomie en laparoscopische colectomie.
    E.1.1.1Medical condition in easily understood language
    The effect of deep muscle relaxation on the abdominal working space during laparosopy.
    Het effect van diepe spierverslapping tijdens kijkoperaties op de chirurgische werkomstandigheden.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    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
    To establish the relationship between the use of deep neuromuscular blockade (NMB) and the abdominal working space (distance from skin to sacral promontory and 3D volume) during laparoscopy with standard pressure pneumoperitoneum.
    Het effect aantonen van diepe spierverslapping op de chirurgische werkruimte (afstand van trocar-promontorium en 3D volume van buikholte) tijdens kijkoperaties met standaard intra-abdominale druk.
    E.2.2Secondary objectives of the trial
    To study the effect of moderate NMB versus no NMB on the abdominal working space (distance from skin to sacral promontory and 3D volume) during laparoscopy with standard pressure pneumoperitoneum.
    We zullen tevens onderzoeken wat het effect is van standaard neuromusculair blok versus geen neuromusculair blok op de chirurgische werkruimte (afstand van trocar-promontorium en 3D volume van buikholte) tijdens kijkoperaties met standaard intra-abdominale druk.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - all adult patients (18 years or older) scheduled for laparoscopic donor nephrectomy, laparoscopic cholecystectomy or laparoscopic colectomy
    - obtained informed consent
    - alle volwassen patiënten (vanaf 18 jaar) gepland voor laparoscopische donornefrectomie, laparoscopische cholecystectomie of laparoscopische colectomie
    - verkregen informed consent
    E.4Principal exclusion criteria
    • Unable to provide informed consent
    • known or suspect allergy to mivacurium, rocuronium or sugammadex
    • neuromuscular disease
    • indication for rapid sequence induction
    • Being unable to undergo MRI due to any reason (e.g. non MRI-compatible implants, epilepsy)
    • BMI>30 kg/m2
    • ASA-score >2
    • Niet is staat tot geven van informed consent
    • Bekende of vermoede allergie voor mivacurium, rocuronium of sugammadex
    • neuromusculaire stoornis
    • indicatie rapid sequence inductie
    • Contraindicatie voor MRI (bijvoorbeeld vanwege epilepsie of MRI incompatibele implantaten)
    • BMI>30 kg/m2
    • ASA-score >2
    E.5 End points
    E.5.1Primary end point(s)
    The abdominal working space space measured by MRI: Skin - sacral promontory distance
    Het chirurgische werkveld gemeten dmv MRI: afstand van trocar tot promontorium
    E.5.1.1Timepoint(s) of evaluation of this end point
    Following induction of general anesthesia and creation of pneumoperitoneum, each patiënt will undergo a MRI scan in 3 phases (total duration 30 minutes)
    - phase 1: no NMB (first scan)
    - phase 2: moderate NMB (second scan)
    - phase 3: deep NMB (third scan)

    After completion of the third scan the laparoscopic procedure will be continued.
    Na inductie van de algehele anesthesie en creëren van het pneumoperitoneum (12 mmHg), zal elke patiënt een MRI scan ondergaan in 3 fasen (totale duur van 30 minuten)
    - fase 1 : geen NMB (eerste scan)
    - fase 2: standaard NMB (tweede scan)
    - fase 3: diep NMB (3e scan)

    Na de 3e scan fase zal de laparoscopische procedure worden gecontinueerd volgens standaard protocol.
    E.5.2Secondary end point(s)
    The abdominal working space space measured by MRI: 3D volume of the abdominal cavity
    Het chirurgische werkveld gemeten dmv MRI: 3D volume van de buikholte
    E.5.2.1Timepoint(s) of evaluation of this end point
    Following introduction of general anesthesia and creation of pneumoperitoneum, each patiënt will undergo a MRI scan in 3 phases (total duration 30 minutes)
    - phase 1: no NMB (first scan)
    - phase 2: moderate NMB (second scan)
    - phase 3: deep NMB (third scan)

    After completion of the third scan the laparoscopic procedure will be continued.
    Na inductie van de algehele anesthesie en creëren van het pneumoperitoneum (12 mmHg), zal elke patiënt een MRI scan ondergaan in 3 fasen (totale duur van 30 minuten)
    - fase 1 : geen NMB (eerste scan)
    - fase 2: standaard NMB (tweede scan)
    - fase 3: diep NMB (3e scan)

    Na de 3e scan fase zal de laparoscopische procedure worden gecontinueerd volgens standaard protocol.
    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 No
    E.6.5Efficacy No
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    prospectieve cohort studie, 3 fases in elke patiënt (geen, standaard en diep NMB)
    prospective cohort study, 3 phases in each patiënt (no, moderate and deep NMB)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    prospectieve cohort studie, 3 fases in elke patiënt (geen, standaard en diep NMB)
    prospective cohort study, 3 phases in each patiënt (no, moderate and deep NMB)
    E.8.2.4Number of treatment arms in the trial1
    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.8.5The 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
    LVLS
    laatste bezoek (operatie), laatste patiënt.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    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: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state8
    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)
    None
    Geen
    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 Decision2017-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-27
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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