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    Summary
    EudraCT Number:2022-003325-22
    Sponsor's Protocol Code Number:2022-15944
    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:2022-11-07
    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 number2022-003325-22
    A.3Full title of the trial
    The immunomodulatory effect of sugammadex after total hip replacement surgery under neuraxial anaesthesia: a pilot study
    Het immunomodulerende effect van Sugammadex na totale heupvervanging chirurgie onder spinale anesthesie: een pilot studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of sugammadex on the postoperative immune function after total hip replacement under neuraxial anesthesia
    Het effect van sugammadex op postoperatieve immuunfunctie na totale heup vervanging chirurgie met een ruggenprik
    A.3.2Name or abbreviated title of the trial where available
    MAGIC study
    A.4.1Sponsor's protocol code number2022-15944
    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 supportRadboudUMC
    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 pointVascular surgery
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein zuid 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525GA
    B.5.3.4CountryNetherlands
    B.5.6E-mailveerle.bijkerk@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 Sugammadex
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    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 nameSugammadex
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hip osteoarthritis
    Heupartrose
    E.1.1.1Medical condition in easily understood language
    Arthrosis of the hip
    Heupslijtage
    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 overall objective of this study is to investigate the potential immunomodulatory effect of sugammadex as seen in previous ex vivo experiments. Specified, the main objective is to investigate the effect of administration of sugammadex without prior neuromuscular blockade on postoperative innate immune function as reflected by cytokine production capacity of mononuclear cells.
    Het hoofddoel van deze studie is om het potentiele immuunmodulerende effect van sugammadex te onderzoeken, zoals het eerder is gezien in ex vivo experimenten.
    Meer gespecificeerd is het hoofddoel van de pilot studie om het effect van toediening van sugammadex, zonder voorafgaande neuromusculaire blokkade, te onderzoeken op postoperatieve aangeboren immuun functie. Dit wordt gemeten door cytokine productie capaciteit van mononucleaire cellen te bepalen.
    E.2.2Secondary objectives of the trial
    To investigate the effect of administration of sugammadex without prior neuromuscular blockade on:
    - Postoperative innate immune function as reflected by DAMP release
    - Systemic inflammation as reflected by circulating inflammatory cytokines
    - Postoperative pain scores and analgesia consumption
    - Postoperative quality of recovery
    - Postoperative (infectious) complications
    Het onderzoeken van het effect van toediening van sugammadex zonder voorafgaande neuromusculaire blokkade op:
    - Postoperatieve immuunfunctie weergegeven als het vrijkomen van DAMPs
    - Systemsiche inflammatie gemeten door circulerende inflammatoire cytokines
    - Postoperatieve pijn en analgetica gebruik
    - Postoperatieve kwaliteit van herstel
    - Postoperatieve (infectieuze) complicaties
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age of 18 years or older
    - Scheduled for total hip replacement surgery under neuraxial surgery
    - Scheduled for primary hip replacement surgery
    - Informed consent obtained
    - 18 jaar of ouder
    - Gepland voor totale heup vervanging onder spinale anesthesie
    - Gepland voor primaire heup vervanging
    - Informed consent verkregen
    E.4Principal exclusion criteria
    - Insufficient control of the Dutch language to read the patient information and to fill out de questionnaires
    - Known or suspected hypersensitivity to sugammadex
    - Deficiency of vitamin K dependent clotting factors or coagulopathy
    - Severe renal disease (creatinine clearance <30 ml/min), including patients on dialysis)
    - Severe liver disease (Child-Pugh Classification C)
    - Women who are or may be pregnant or currently breastfeeding
    - Severe vertebral column disorder
    - Chronic use of psychotropic drugs
    - Known hypertrophic obstructive cardiomyopathy, severe aortic valve stenosis or severe mitral valve stenosis
    - Use of immunomodulatory medication
    - Onvoldoende kennis van Nederlandse taal om patiënteninformatie te lezen en vragenlijsten in te vullen
    - Bekende of verdachte overgevoeligheid voor of sugammadex
    - Vitamine K-afhankelijke stollingsfactoren deficiëntie of coagulopathie
    - Ernstig leverfalen (Child-Pugh classificatie C)
    - Ernstige nierinsufficiëntie (kreatinie klaring <30 ml/min), inclusief dialyse patiënten
    - Ernstige aandoeningen van de wervelkolom
    - Vrouwen die zwanger zijn of borstvoeding geven
    - Chronisch gebruik van psychotropische medicatie of immuunmodulerende medicatie
    - Bekende hypertrofische obstructieve cardiomyopathie, ernstige aortaklepstenose of ernstige mitralisklepstenose
    E.5 End points
    E.5.1Primary end point(s)
    Innate immune function as reflected by
    - Ex vivo cytokine (TNF-α, IL-6, IL-10, IL-1β) production capacity of mononuclear cells upon whole blood lipopolysaccharide (LPS) stimulation.
    Aangeboren immuunfunctie weergegeven door:
    - Ex vivo cytokine productie capaciteit (TNF-α, IL-6, IL-10, IL-1β) van mononucleaire cellen op volbloed stimulatie met lipopolysaccharide
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of surgery
    Postoperative day 1
    Einde van operatie
    Postoperatieve dag 1
    E.5.2Secondary end point(s)
    - Innate immune function at the end of surgery and postoperative day 1 as reflected by
    - Circulating inflammatory cytokines (TNF-α, IL-6, IL-10)
    - DAMP release (HSP70, HMGB1)
    - Pain scores (NRS 0-10) and total analgesia consumption at the post anesthesia care unit (PACU) and postoperative day 1.
    - Quality of Recovery score (QoR-40) at postoperative day 1(11).
    - 30-day postoperative infectious complications scored according to the relevant endpoint of the StEP-COMPAC group initiative
    - 30-day postoperative complications scored by Clavien Dindo classification.
    - Aangeboren immuunfunctie aan het eind van de operatie en op postoperatieve dag 1 gemeten door:
    - Circulerende inflammatoire cytokines (TNF-α, IL-6, IL-10)
    - DAMP afgifte (HSP70, HMGB1)
    - Pijnscores (NRS 0-10) en totaal analgetica gebruik tot en met postoperatieve dag 1
    - Kwaliteit van herstel score (QoR-40) op postoperatieve dag 1
    - 30 dagen postoperatieve complicaties gekwalificeerd volgens Clavien-Dindo classificatie
    - 30 dagen infectieuze complicaties geclassificeerd volgens de StEP-COMPAC groep
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of surgery
    Post anesthesia care unit
    Postoperative day 1
    Postoperative day 30
    Einde van de operatie
    Post anesthesie care unit
    Postoperatieve dag 1
    Postoperatieve dag 30
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 No
    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 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
    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 months8
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state20
    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 applicable.
    All patients in the MAGIC trial wil undergo total hip replacement surgery under neuraxial anesthesia. At the end of surgery they will receive sugammadex or placebo. After surgery both groups will follow standard care routines.
    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 Decision2022-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-25
    P. End of Trial
    P.End of Trial StatusCompleted
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