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    Summary
    EudraCT Number:2011-004005-24
    Sponsor's Protocol Code Number:EC04-2010
    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:2012-06-01
    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 number2011-004005-24
    A.3Full title of the trial
    Sulfato de magnesio y ketamina como coadyuvantes anestésicos en artroplastia de rodilla:
    efectos sobre los requerimientos analgésicos periperatorios.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sulfato de magnesio y ketamina utilizados como complementos anestésicos en la colocación de prótesis de rodilla: Efectos sobre los requerimientos analgésicos periperatorios.
    A.4.1Sponsor's protocol code numberEC04-2010
    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 SponsorComplejo Hospitalario Torrecárdenas
    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 supportMINISTERIO DE POLITICA SOCIAL
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFIBAO (Fundación Pública Andaluza para la Investigación Biosanitaria de Andalucía Oriental-Alejandro Otero)
    B.5.2Functional name of contact pointJosé Galván Espinosa
    B.5.3 Address:
    B.5.3.1Street AddressParaje Torrecárdenas S/N
    B.5.3.2Town/ cityAlmería
    B.5.3.3Post code04009
    B.5.3.4CountrySpain
    B.5.4Telephone number699863917
    B.5.5Fax number950016531
    B.5.6E-mailjose.galvan.exts@juntadeandalucia.es
    D. IMP Identification
    D.IMP: 1
    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 ketolar
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratórios Pfizer, Lda., Porto Salvo, Portugal
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameketamina
    D.3.2Product code ketamina
    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 INNKETAMINE
    D.3.9.1CAS number 6740-88-1
    D.3.9.4EV Substance CodeSUB08365MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 sulmetin simple endovenoso
    D.2.1.1.2Name of the Marketing Authorisation holderLabesfal - Laboratórios Almiro, S.A., Santiago de Besteiros, Portugal
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameMagnesium sulfate
    D.3.2Product code Magnesium sulfate
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 7487-88-9
    D.3.9.2Current sponsor codeMAGNESIUM SULFATE
    D.3.9.3Other descriptive nameMAGNESIUM SULFATE
    D.3.9.4EV Substance CodeSUB14448MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postoperative pain.
    Hypomagnesemia in surgical patients.
    Dolor postoperatorio.
    Hipomagnesemia en pacientes quirúrgicos.
    E.1.1.1Medical condition in easily understood language
    Pain after surgery.
    Low levels of magnesium in blood after surgery.
    Dolor tras cirugía.
    Niveles bajos de magnesio en sangre tras cirugía.
    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
    Evaluar la eficacia analgésica de diferentes pautas de administración de fármacos bloqueantes
    de receptores de NMDA.
    E.2.2Secondary objectives of the trial
    - Evaluar el consumo intraoperatorio y postoperatorio de opiáceos, e intraoperatorio de
    relajantes musculares e hipnóticos en relación con las diferentes pautas de administración de
    fármacos bloqueadores de receptores de NMDA.
    -Determinar la frecuencia de pacientes intervenidos de artroplastia de rodilla que presentan
    hipomagnesemia durante la estancia hospitalaria, así como la asociación de hipomagnesemia
    con otros trastornos hidroelectrolíticos.
    - Describir la evolución de los niveles de magnesio en sangre y orina durante el ingreso.
    - Evaluar si existe asociación entre la excreción urinaria de magnesio tras la sobrecarga del
    mismo, con la eficacia analgésica de los diferentes protocolos analgésicos con fármacos
    bloqueantes NMDA.
    - Evaluar la frecuencia de temblores, naúseas y vómitos, depresión respiratoria,
    broncoespasmo, sedación y prurito postoperatorios en los diferentes grupos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Edad superior a 18 años.
    No superar el grado IV de la escala de valoración del estado físico de la clasificación de la
    American Society of Anesthesiologists.
    Presentar voluntad explícita de participar en el estudio mediante consentimiento
    informado.
    Responder adecuadamente al cuestionario acerca de la compresión de la técnica de PCA, previa explicación.
    E.4Principal exclusion criteria
    Menores de edad.
    Hipersensibilidad a ketamina o sulfato de magnesio.
    Alergia a algún componente del protocolo de estudio.
    Desórdenes musculares, neurológicos y/o psiquiátricos.
    Hipertensión arterial no controlada.
    Insuficiencia cardíaca congestiva crónica (grado de NYHA > 3-4).
    Isquemia miocárdica.
    Historia de abuso de alcohol u otras drogas.
    Insuficiencia renal moderada o grave (Creatininemia > 2 mg/dl).
    Hipocalcemia o tratamiento con antagonistas del calcio.
    Antecedentes anestésicos de vía aérea difícil o Mallampati IV en la exploración de la vía
    aérea.
    No dar consentimiento para participar en el estudio o revocación del mismo.
    E.5 End points
    E.5.1Primary end point(s)
    El tratamiento perioperatorio con antagonistas del receptor NMDA reduce el consumo de opiáceos (remifentanilo intraoperatorio y morfina en el
    postoperatorio) y sus efectos adversos, así como la intensidad del dolor postoperatorio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 años
    E.5.2Secondary end point(s)
    2.1 Evaluar el consumo intraoperatorio y postoperatorio de opiáceos, e intraoperatorio de
    relajantes musculares e hipnóticos en relación con las diferentes pautas de administración de
    fármacos bloqueadores de receptores de NMDA.
    2.2 Determinar la frecuencia de pacientes intervenidos de artroplastia de rodilla que presentan
    hipomagnesemia durante la estancia hospitalaria, así como la asociación de hipomagnesemia
    con otros trastornos hidroelectrolíticos.
    2.3 Describir la evolución de los niveles de magnesio en sangre y orina durante el ingreso.
    2.4 Evaluar si existe asociación entre la excreción urinaria de magnesio tras la sobrecarga del
    mismo, con la eficacia analgésica de los diferentes protocolos analgésicos con fármacos
    bloqueantes NMDA.
    2.5 Evaluar la frecuencia de temblores, naúseas y vómitos, depresión respiratoria,
    broncoespasmo, sedación y prurito postoperatorios en los diferentes grupos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 año
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) Yes
    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 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
    triple ciego
    Triple blind
    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 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
    No procede
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state115
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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)
    It is not diferent
    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 Decision2012-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-24
    P. End of Trial
    P.End of Trial StatusOngoing
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