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    Summary
    EudraCT Number:2019-003033-42
    Sponsor's Protocol Code Number:EURO-RELAX
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-20
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-003033-42
    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
    Impacto de una estrategia de bloqueo neuromuscular profundo versus bloqueo  estándar en  la seguridad intraoperatoria en cirugía laparoscópica: estudio internacional multicéntrico 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
    Impacto del bloqueo neuromuscular profundo versus bloqueo  estándar en  la seguridad intraoperatoria en cirugía laparoscópica: EURO RELAX
    A.3.2Name or abbreviated title of the trial where available
    EURO RELAX STUDY
    ESTUDIO EURO RELAX
    A.4.1Sponsor's protocol code numberEURO-RELAX
    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 SponsorINSTITUTO DE INVESTIGACIÓN SANITARIA LA FE
    B.1.3.4CountrySpain
    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 DE ESPAÑA, S.A
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINSTITUTO DE INVESTIGACION SANITARIA LA FE
    B.5.2Functional name of contact pointCLINICAL TRIALS INFORMATION
    B.5.3 Address:
    B.5.3.1Street AddressAV. FERNANDO ABRIL MARTORELL 106
    B.5.3.2Town/ cityVALENCIA
    B.5.3.3Post code46026
    B.5.3.4CountrySpain
    B.5.6E-mailinvestigacion_clinica@iislafe.es
    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
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 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.3.9.3Other 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 typerange
    D.3.10.3Concentration number0.9 to 1
    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 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 Bridion
    D.2.1.1.2Name of the Marketing Authorisation holderMSD
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 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.3.9.1CAS number 343306-79-6
    D.3.9.3Other descriptive nameSUGAMMADEX SODIUM
    D.3.9.4EV Substance CodeSUB32205
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    Seguridad intraoperatoria en cirugía laparoscópica
    E.1.1.1Medical condition in easily understood language
    Adverse events during laparoscopic surgery
    Seguridad en cirugía laparoscópica
    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
    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.
    Estudiar el efecto del bloqueo neuromuscular profundo en comparación con el bloqueo neuromuscular estándar en los eventos adversos intraoperatorios durante la cirugía laparoscópica utilizando el sistema de puntuación CLASSIC.
    E.2.2Secondary objectives of the trial
    To study the effect of deep neuromuscular block as compared to standard neuromuscular block on:
    • Surgical working conditions (L-SRS)
    • 30 day post-operative complications (Clavien-Dindo)
    • 30-day post-operative complications according to the Comprehensive Complication Index
    • 30 day unplanned readmission rates


    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)
    Estudiar el efecto del bloqueo neuromuscular profundo en comparación con el bloqueo neuromuscular estándar en:
    • Condiciones de trabajo quirúrgicas (L-SRS)
    • Complicaciones postoperatorias a 30 días (Clavien-Dindo)
    • Complicaciones postoperatorias de 30 días según el Índice de complicaciones completas
    • Tasas de readmisión no planificada de 30 días


    -Calidad de la recuperación en el postoperatorio los días 1, 2 y 30 después de la cirugía laparoscópica.
    -Calidad de recuperación (QoR-40 en los días 1 y 2 del postoperatorio; puntuación de Aldrete en la PACU)
    -Calidad de vida en el día 30 postoperatorio (SF36)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a patient must meet all of the following criteria:
    • Patients scheduled for elective laparoscopic procedure with a complexity according to the BUPA classification for case complexity: ‘MAJOR’, ‘MAJOR PLUS’ or ‘COMPLEX MAJOR’
    • ASA class I-III
    • > 18 years of age
    • Ability to give oral and written informed consent
    Para ser elegible para participar en este estudio, un paciente debe cumplir con todos los siguientes criterios:
    • Pacientes con cirugía laparoscópica programada, sleccionado con una complejidad según la clasificación BUPA de: "MAYOR", "MAYOR PLUS" o "MAYOR COMPLEJO"
    • ASA clase I-III
    •> 18 años de edad
    • Capacidad para dar consentimiento informado oral y escrito.
    E.4Principal exclusion criteria
    • Low or intermediate complexity laparoscopic procedures (BUPA ‘SIMPLE’ or ‘INTER’)
    • Known or suspected neuromuscular disorders impairing neuromuscular function
    • Allergies to muscle relaxants, anesthetics or narcotics
    • A (family) history of malignant hyperthermia
    • Women who are or may be pregnant or are currently breast feeding
    • Chronic use of any type of opioid or psychotropic drug
    • Use of NSAID’s shorter than 5 days before surgery
    • Indication for rapid sequence induction
    • Contra-indication for sugammadex use (e.g. known sugammadex allergy or GFR<30 ml/min)
    Procedimientos laparoscópicos de complejidad baja o intermedia (BUPA ‘SIMPLE’ o ‘INTER’)
    • Trastornos neuromusculares conocidos o sospechosos que afectan la función neuromuscular
    • Alergias a relajantes musculares, anestésicos o narcóticos
    • Antecedentes (familiares) de hipertermia maligna.
    • Mujeres que están o pueden estar embarazadas o están amamantando.
    • Uso crónico de cualquier tipo de opioide o psicotrópico.
    • Uso de AINES de menos de 5 días antes de la cirugía
    • Indicación para inducción de secuencia rápida.
    • Contraindicación para el uso de sugammadex (por ejemplo, alergia conocida a sugammadex o GFR <30 ml / min)
    E.5 End points
    E.5.1Primary end point(s)
    Intra-operative adverse events evaluated with the CLASSIC Score form
    Efectos adversos intra-operatorios evaluados con el formulario CLASSIC Score
    E.5.1.1Timepoint(s) of evaluation of this end point
    during laparoscopic surgery
    durante la cirugía laparoscópica
    E.5.2Secondary end point(s)
    Study the effect of deep neuromuscular block as compared to standard neuromuscular block on:
    • Surgical working conditions (L-SRS)
    • 30 day post-operative complications (Clavien-Dindo)
    • 30-day post-operative complications according to the Comprehensive Complication Index
    • 30 day unplanned readmission rates
    • Quality of recovery at post-operative day 1, 2 and 30 after laparoscopic surgery.
    o Quality-of-recovery (QoR-40 at postoperative day 1 and 2; Aldrete score at
    the PACU)
    o Quality-of-life at postoperative day 30 (SF36)
    Estudiar el efecto del bloqueo neuromuscular profundo en comparación con el bloqueo neuromuscular estándar en:
    • Condiciones de trabajo quirúrgicas (L-SRS)
    • Complicaciones postoperatorias a 30 días (Clavien-Dindo)
    • Complicaciones postoperatorias de 30 días según el Índice de complicaciones completas
    • Tasas de readmisión no planificada de 30 días
    • Calidad de recuperación en el postoperatorio los días 1, 2 y 30 después de la cirugía laparoscópica.
    o Calidad de recuperación (QoR-40 en el día 1 y 2 postoperatorios; puntuación de Aldrete en
    la URPA)
    o Calidad de vida en el día 30 postoperatorio (SF36)
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the 30 post-operative days.
    Durante los 30 días post-operatorios.
    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
    El mismo medicamento con diferentes dosis
    The same medicinal product with different doses
    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
    LVLS
    LVLS
    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
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 230
    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 state230
    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)
    Usual clinical practice
    Práctica clínica habitual
    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 Decision2020-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-18
    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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