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    Summary
    EudraCT Number:2012-004538-40
    Sponsor's Protocol Code Number:MAGLIDIT-12
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-12
    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 number2012-004538-40
    A.3Full title of the trial
    Magnesium associated to intratecal lidocaine decreases the incidence of the Transitory Neurologic Syndrome following same-day-surgery
    ?El magnesio asociado a la lidocaína intratecal disminuye la incidencia del Síndrome Neurológico Transitorio tras la Cirugía Mayor Ambulatoria?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Magnesium blocks the buttocks pain that may appear after spinal anesthesia
    El magnesio puede bloquear el dolor glúteo que puede aparecer tras la anestesia espinal
    A.3.2Name or abbreviated title of the trial where available
    MAGLIDIT
    MAGLIDIT
    A.4.1Sponsor's protocol code numberMAGLIDIT-12
    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 SponsorHospital General de Ciudad Real
    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 supportFundación Mútua Madrileña
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital General Universitario de Ciudad Real
    B.5.2Functional name of contact pointUnidad de Investigación
    B.5.3 Address:
    B.5.3.1Street Addressc/ Obispo Rafael Torija s/n
    B.5.3.2Town/ cityCiudad Real
    B.5.3.3Post codeCiudad Real
    B.5.3.4CountrySpain
    B.5.4Telephone number34926278000313
    B.5.5Fax number34926278540
    B.5.6E-maileseguram@sescam.jccm.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 MAGNESIO LAVOISIER
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires CHAIX et DU MARAIS
    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 Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradural 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.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 Fentanest
    D.2.1.1.2Name of the Marketing Authorisation holderKern Pharma
    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 Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradural 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postanesthetic transitory neurologic syndrome
    Síndrome neurológico transitorio postanestésico
    E.1.1.1Medical condition in easily understood language
    Postanesthetic buttocks pain
    Dolor glúteo postanestésico
    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
    Determine rate of postanesthetic transitory neurologic syndrome (buttocks pain)
    Determinar la incidencia posoperatoria del síndrome neurológico transitorio (Dolor glúteo)
    E.2.2Secondary objectives of the trial
    1. Time to home discharge
    2. Duration of sensitive block
    3. Ammount of postoperative analgesia needed
    4. Duration of motor block
    5. Time to voiding
    6. Time to oral intake
    7. Posoperative nausea(vomiting rate
    8. Inadequate anesthesia rate and conversion to general anesyhesia
    9. Rate of unexpected ward admisssion and reason for
    1. Tiempo transcurrido desde la instauración de la anestesia hasta que se produzca la firma del alta de la unidad de Cirugía Ambulatoria
    2. Tiempo de duración del bloqueo sensitivo (momento en que el paciente requiere analgesia adicional)
    3. Cuantificación de la necesidad de analgesia postoperatoria
    4. Tiempo de duración del bloqueo motor como capacidad para deambular
    5. Tiempo hasta la micción espontánea
    6. Tiempo hasta la tolerancia oral
    7. Incidencia de náuseas o vómitos
    8. Incidencia de anestesia inadecuada intraoperatoria en grado de i) suplementación, o en grado ii) conversión a anestesia general
    9. Incidencia de admisiones no programadas y su causa
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Same day surgery
    2. Both genders. Pregnancy in fertile women ruled out by serum or urine check preoperatively.
    3. Operated in lithotomy position or
    4. Arthroscopy position or
    5. Obese in any position, with infraumbilical incision
    6. Spinal lidocaine anesthetic


    aine anesthesia
    1 Pacientes operados vía Cirugía Mayor Ambulatoria (CMA) y
    2 Ambos sexos incluídos. Mujeres en edad fertil con embarazo excluido mediante prueba analítica preoperatoria en suero u en orina.
    3 Intervenidos en postura de litotomía, o
    4 Postura de artroscopìa de rodilla, o
    5 Obesos en cualquier postura, con incisión infraumbilical
    6 Anestesia espinal con lidocaína
    E.4Principal exclusion criteria
    a) Younger than 18 years old or older than 80 years old.
    b) American Society of Anesthesia class 3 or 4
    c) Active low back pain
    d) Any myopathy or neuropathy
    e) Pregnant or breast-feeding women
    f) Known allergy or sensitivity to lidocaine, magnesium or fentanyl
    g) Known intracardiac electrical conduction defect seen in the electrocardiogram
    a) pacientes de menos de 18 años o de más de 80
    b) American Society of Anesthesia clase 3 y 4,
    c) dolor lumbar crónico ACTIVO
    d) pacientes con miopatías y neuropatías de toda índole
    e) mujeres embarazadas o en lactancia (ver E.3)
    f) antecedentes de alergia o sensibilidad a la lidocaína, magnesio, fentanilo
    g) defecto de conducción eléctrica intracardiaca en el electrocardiograma
    E.5 End points
    E.5.1Primary end point(s)
    Postoperative Transitory neurologic syndrome (buttocks pain) rate
    Incidencia posoperatoria del síndrome neurológico transitorio (dolor glúteo)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Second, fourth and sixth posoperative day
    Día segundo, cuarto y sexto posoperatorio
    E.5.2Secondary end point(s)
    1. Time to home discharge
    2. Duration of sensitive block
    3. Ammount of postoperative analgesia needed
    4. Duration of motor block
    5. Time to voiding
    6. Time to oral intake
    7.Posoperative nausea/vomiting rate
    8. Inadequate anesthesia rate and conversion to general anesyhesia
    9. Rate of unexpected ward admisssio and reason
    1. Tiempo transcurrido desde la instauración de la anestesia hasta que se produzca la firma del alta de la unidad de CMA (UCMA) por el servicio de anestesia
    2. Tiempo de duración del bloqueo sensitivo (momento en que el paciente requiere analgesia adicional)
    3. Cuantificación de la necesidad de analgesia postoperatoria
    4. Tiempo de duración del bloqueo motor como capacidad para deambular
    5. Tiempo hasta la micción espontánea
    6. Tiempo hasta la tolerancia oral
    7. Incidencia de náuseas o vómitos
    8. Incidencia de anestesia inadecuada intraoperatoria en grado de i) suplementación, o en grado ii) conversión a anestesia general
    9. Incidencia de admisiones no programadas y su causa
    E.5.2.1Timepoint(s) of evaluation of this end point
    Inmediate postoperative hours till dischage from the unit
    Horas posoperatorias inmediatas hasta producirse el alta de la unidad
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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) 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 Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Mi respuesta quiere ser "no" pero la aplicación funciona mal y me obliga a escribir aquí algo
    Mi answer want to be "no", but the aplication understands yes and forces me to write here something
    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
    fentanilo
    fentanest
    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
    seven days after the last patient is recruited
    siete días después de la inclusión del último paciente
    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 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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state80
    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
    Ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-22
    P. End of Trial
    P.End of Trial StatusCompleted
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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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