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    Summary
    EudraCT Number:2021-001503-33
    Sponsor's Protocol Code Number:2019PI200
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-06
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-001503-33
    A.3Full title of the trial
    The impact of deep versus standard muscle relaxation on intra-operative safety during laparoscopic surgery: a multicenter strategy study – EURO RELAX STUDY
    L'impact de la relaxation musculaire profonde comparé à la relaxation musculaire standard sur la sécurité per-opératoire pendant la chirurgie laparoscopique : une étude stratégique multicentrique - Etude EURO RELAX
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The impact of deep versus standard muscle relaxation on intra-operative safety during laparoscopic surgery – EURO RELAX STUDY
    L'impact d'un relâchement musculaire profond comparé à un relâchement musculaire standard sur la sécurité pendant la chirurgie par coelioscopie : Etude EURO RELAX
    A.3.2Name or abbreviated title of the trial where available
    EURO RELAX STUDY
    Etude EURO RELAX
    A.4.1Sponsor's protocol code number2019PI200
    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 SponsorCHRU de Nancy
    B.1.3.4CountryFrance
    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 supportMSD FRANCE
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportCHRU de Nancy
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU de Nancy
    B.5.2Functional name of contact pointDirection de la Recherche Clinique
    B.5.3 Address:
    B.5.3.1Street AddressCHRU de Nancy
    B.5.3.2Town/ cityVandoeuvre lès Nancy
    B.5.3.3Post code54511
    B.5.3.4CountryFrance
    B.5.4Telephone number+33383 15 5285
    B.5.5Fax number+33383 15 7451
    B.5.6E-maildripromoteur@chru-nancy.fr
    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
    D.2.1.1.2Name of the Marketing Authorisation holderMSD France
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROCURONIUM
    D.3.9.1CAS number 119302-91-9
    D.3.9.2Current sponsor coderoucuronium
    D.3.9.3Other descriptive nameROCURONIUM
    D.3.9.4EV Substance CodeSUB04260MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Intra-operative adverse events during laparoscopic surgery
    Evènement indésirable pendant l'intervention laparoscopique
    E.1.1.1Medical condition in easily understood language
    Adverse events during laparoscopic surgery
    Evènement indésirable pendant l'intervention par coelioscopie
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10058468
    E.1.2Term Laparoscopic surgery
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the effect of deep neuromuscular block compared to standard neuromuscular block on intra-operative adverse events during laparoscopic surgery using the CLASSIC score system
    Étudier à l'aide du système de score CLASSIC l'effet du bloc neuromusculaire profond par rapport au bloc neuromusculaire standard sur les événements indésirables pendant une chirurgie laparoscopique
    E.2.2Secondary objectives of the trial
    To study the effect of deep neuromuscular block as compared to standard neuromuscular block on:
    1/ Surgical working conditions (L-SRS)
    2/ 30-day post-operative complications (Clavien-Dindo)
    3/ 30-day post-operative complications according to the Comprehensive Complication Index ((https://www.assessurgery.com/)
    4/ 30-day unplanned readmission rates
    5/Quality of recovery at post-operative day 1, 2 and 30 after laparoscopic surgery:
    -Quality-of-recovery (QoR-40 at postoperative day 1 and 2; Aldrete score at the PACU)
    -Quality-of-life at postoperative day 30 (SF36)

    Étudier l’effet d’un bloc neuromusculaire profond comparé au bloc neuromusculaire standard sur :
    1/ Conditions chirurgicales (L-SRS)
    2/ Complications chirurgicales postopératoires jusqu’au J30 (selon Clavien-Dindo)
    3/ Complications chirurgicales post-opératoires jusqu’au J30 (selon Comprehensive Complication Index)
    4/ Taux de réadmissions non planifiées dans les premiers 30 jours pos-topératoires
    5/ Qualité de récupération post-opératoire à J1, J2 et J30
    - en SSPI : score d’Aldrete
    - à J1 et J2 : questionnaire QoR-40
    - à J30 : questionnaire SF36
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1/ Patients scheduled for elective laparoscopic procedure with a complexity according to the BUPA classification for case complexity: ‘MAJOR’, ‘MAJOR PLUS’ or ‘COMPLEX MAJOR’
    2/ ASA class I-III
    3/ > 18 years of age
    4/ Ability to give oral and written informed consent
    1/ Patients devant subir une intervention laparoscopique élective dont la complexité est conforme à la classification BUPA des cas complexes : "MAJEUR", "MAJEUR PLUS" ou "COMPLEXE MAJEUR".
    2/ Classe ASA 1-3
    3/ d'âge supérieur à 18 ans
    4/ Capacité à donner un consentement éclairé oral et écrit.
    E.4Principal exclusion criteria
    1/ Low or intermediate complexity laparoscopic procedures (BUPA ‘SIMPLE’ or ‘INTER’)
    2/ Known or suspected neuromuscular disorders impairing neuromuscular function
    3/ Allergies to muscle relaxants, anesthetics or narcotics mentioned in paragraph 7
    4/ A (family) history of malignant hyperthermia
    5/ Women who are or may be pregnant or are currently breast feeding
    6/ Chronic use of any type of opioid or psychotropic drug
    7/ Use of NSAID’s shorter than 5 days before surgery
    8/ Indication for rapid sequence induction
    9/ Contra-indication for sugammadex use (e.g. known sugammadex allergy or GFR<30 ml/min)
    10/ Persons deprived of liberty for judicial or administrative decision
    11/ Persons in health or social institutions for another reason than research
    12/ Minors (non emancipated)
    13/ Adult persons under legal protection (any form of public guardianship)
    14/ Persons incapable of giving consent and not under legal protection
    1/ Chirurgie coelioscopique avec une complexité faible ou intermédiaire selon la classification BUPA.
    2/ Troubles neuromusculaires connus ou suspectés, altérant la fonction neuromusculaire.
    3/ Allergies aux myorelaxants, aux anesthésiques ou aux hypnotique mentionnés au paragraphe 7.
    4/ Antécédents (familiaux) d'hyperthermie maligne.
    5/ Femmes enceintes ou susceptibles de l'être, ou allaitantes.
    6/ Utilisation chronique de tout type d'opioïde ou de médicament psychotrope
    7/ Prise d'AINS dans les 5 jours avant la chirurgie
    8/ Indication pour une induction à séquence rapide (ISR)
    9/ Contre-indication au sugammadex (par exemple, allergie connue au sugammadex ou GFR<30 ml/min)
    10/ Personnes privées de liberté pour décision judiciaire ou administrative
    11/ Personnes dans des institutions sanitaires ou sociales pour une autre raison que la recherche
    12/ Mineurs (non émancipés)
    13/ Personnes majeures sous protection juridique (toute forme de tutelle publique)
    14/ Personnes incapables de donner leur consentement et non placées sous protection juridique.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of intra-operative adverse events (CLASSIC grade ≥ 2) between deep and standard NMB
    Incidence du score CLASSIC ≥ 2
    E.5.1.1Timepoint(s) of evaluation of this end point
    During laparoscopic surgery
    Pendant la chirurgie coelioscopique
    E.5.2Secondary end point(s)
    1/ Surgical working conditions (L-SRS)
    2/ 30-day post-operative complications (Clavien-Dindo grade ≥ 2)
    3/ 30-day post-operative complications according to the Comprehensive Complication Index ((https://www.assessurgery.com/)
    4/ 30-day unplanned re-admissions
    5/ Quality-of-recovery
    at the PACU: Aldrete score
    at post-operative day 1 and day 2 : Quality-of-recovery (QoR-40)
    at post-operative day 30 : Quality-of-life (SF36)
    1/ Conditions chirurgicales : L-SRS
    2/ Complications chirurgicales à 30 jour postopératoires en utilisant Clavien-Dindo
    3/ Complication chirurgicales 30 jour en utilsant "compehension complication index "
    4/ taux de réadmission en urgence (ou en hospitalisation? peut importe le service?) dans les 30 jours postopératoires
    5/ Qualité de récupération post-opératoire
    En SSPI : score d’Aldrete,
    à J1 et J2 : score de QoR-40,
    et à J30 : score de SF36
    E.5.2.1Timepoint(s) of evaluation of this end point
    1/During laparoscopic surgery
    2/ during the 30 post-operative days
    3/ during the 30 post-operative days
    4/ during the 30 post-operative days
    5/
    at the PACU: Aldrete score
    at post-operative day 1 and day 2 : Quality-of-recovery
    during the 30 post-operative days : Quality-of-life
    1/Pendant la chirurgie coelioscopique
    2/ les 30 jours post-opératoires
    3/ les 30 jours post-opératoires
    4/ les 30 jours post-opératoires
    5/ Qualité de récupération post-opératoire
    En SSPI
    à J1 et J2
    et à J30
    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 No
    E.6.4Safety Yes
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    bloc neuromusculaire standard
    standard neuromuscular block
    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 Yes
    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
    30 days post-operative
    30 jours post-opératoires
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state184
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 738
    F.4.2.2In the whole clinical trial 922
    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
    None
    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 Decision2021-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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