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    Summary
    EudraCT Number:2016-002924-99
    Sponsor's Protocol Code Number:NL.58160.091.16
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-08-08
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-002924-99
    A.3Full title of the trial
    The effectiveness of deep versus moderate neuromuscular blockade during laparoscopic donor nephrectomy in enhancing postoperative recovery.
    Het effect van diepe spierverslapping tijdens laparoscopische donor nefrectomie op het postoperatieve herstel.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effectiveness of deep muscle relaxation on recovery after kidney donation.
    Het effect van diepe spierverslapping op het herstel na nierdonatie.
    A.3.2Name or abbreviated title of the trial where available
    RELAX study
    RELAX studie
    A.4.1Sponsor's protocol code numberNL.58160.091.16
    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 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+31243615333
    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 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.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
    Live kidney donation is currently the most effect strategy to manage the shortage of donor kindeys for transplantation.
    Optimizing the safety and postoperative recovery after laparoscopic donornephrectomy is of great importance to increase the number of living kindey donors. We will investigate the effect of deep neuromuscular blockade on the quality of the early recovery after laparoscopic donornephrectomy.
    Levende niertransplantaties zijn de meest effectieve manier om het tekort aan donornieren voor transplantatie aan te pakken.
    Daarom is het van groot belang dat de veiligheid en het postoperatieve herstel na laparoscopische donornefrectomie geoptimaliseerd wordt, om zo het aantal leven nierdonoren te vergroten.
    Wij onderzoeken het effect van diepe spierverslapping tijdens laparoscopische donornefrectomie op de kwaliteit van het vroege postoperatieve herstel.
    E.1.1.1Medical condition in easily understood language
    Postoperative recovery after living kidney donation.
    Herstel na levende nier donatie.
    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) during laparoscopic donor nephrectomy (LDN) -with standard pressure pneumoperitoneum- and the early quality of recovery.
    Het effect aantonen van diepe versus normale verslapping tijdens laparoscopische donornefrectomie, op het
    postoperatieve herstel.
    E.2.2Secondary objectives of the trial
    To establish the relationship between the use of deep neuromuscular blockade (NMB) during laparoscopic donor nephrectomy (LDN) on the postoperative painscores, postoperative cumulative use analgesics and anti-emetics, and complications
    Het effect aantonen van diepe versus normale verslapping tijdens laparoscopische donornefrectomie op postoperatieve pijnscores, postoperatief cumulatief gebruik van analgetica en anti-emetica en het optreden van complicaties.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients scheduled for live kidney donation:
    - 18 years or older
    - obtained informed consent
    Alle patienten gepland voor levende nierdonatie:
    - vanaf 18 jaar
    - verkregen informed consent
    E.4Principal exclusion criteria
    . insufficient control of the Dutch language to read the patient information and to fìll out the questionnaires
    . chronic use of analgesics or psychotropic drugs
    . use of NSAIDs shorter than 5 days before surgery
    . known or suspect allergy to rocuronium of sugammadex
    . neuromuscular disease
    . indication for rapid sequence induction
    - onvoldoende beheersing van de Nederlandse taal om patientinformatie te lezen en vragenlijstén in te vullen
    - chronisch gebruik van pijnstillers of psychiatrische voorgeschiedenis/medicatie
    - gebruik van NSAIDS minder dan 5 dagen voorafgaand aan operatie
    - bekende of verdenking op allergie voor rocuronium of sugammadex
    - neuromusculaire afwijking
    - indicatie voor rapid sequence inductie
    E.5 End points
    E.5.1Primary end point(s)
    The Quality of Recovery score (QoR-40 questionnaire)
    De quality of Recovery score (QoR-40 vragenliijst, over het postoperatieve herstel)
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hours after detubation
    24 uur na detubatie
    E.5.2Secondary end point(s)
    Quality of Recovery score (QoR 40 questionnaire)
    Differentiated pain scores
    Cumulative us e of analgesics and anti-emetics
    Discharge criteria
    Complications
    Work and Healthcare questionnaire
    Quality of Recovery score (Qor-40 vragenlijst)
    Gedifferentieerde pijnscores
    Cumulatieve gebruik van analgetica of anti-emetica
    Ontslagcriteria
    Complicaties
    Werk en zorg vragenlijst
    E.5.2.1Timepoint(s) of evaluation of this end point
    Quality of Recovery score: 48 hours after detubation
    Differentiated pain scores: 1, 4, 8, 24 and 48 hours after detubation and after 4 weeks
    Cumulative us e of analgesics and anti-emetics: 1, 4, 8, 24 and 48 hours after detubation
    Discharge criteria: 8, 24 and 48 hours after detubation
    Complications: 24 and 48 hours after detubation and after 4 weeks
    Work and Healthcare questionnaire: 4 weeks postoperative
    Quality of Recovery score (Qor-40 vragenlijst): 48 uur na detubatie
    Gedifferentieerde pijnscores: 1, 4, 8, 24 en 48 uur na detubatie en na 4 weken
    Cumulatieve gebruik van analgetica of anti-emetica: 1, 4, 8, 24 en 48 uur na detubatie
    Ontslagcriteria: 8, 24 en 48 uur na detubatie
    Complicaties: 24 en 48 uur na detubatie en na 4 weken
    Werk en zorg vragenlijst: 4 weken postoperatief
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned2
    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 van laatste patiënt
    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 months4
    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: 96
    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 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 state96
    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 Decision2016-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-27
    P. End of Trial
    P.End of Trial StatusCompleted
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