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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2011-001091-18
    Sponsor's Protocol Code Number:FIBHGM-ECNC002-2011
    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:2011-09-20
    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 number2011-001091-18
    A.3Full title of the trial
    Comparative, randomized, double-blind clinical trial on 50 effective plasma concentration of propofol required for insertion of the Supreme Laryngeal Mask with or without association of remifentanil.
    Estudio comparativo, randomizado y doble ciego de la concentración plasmática efectiva 50 de propofol requerida para la inserción de la Macarilla Laríngea Supreme con o sin asociación de remifentanilo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    concentración plasmática efectiva 50 de propofol requerida para la inserción de la Macarilla Laríngea Supreme con o sin asociación de remifentanilo.
    A.4.1Sponsor's protocol code numberFIBHGM-ECNC002-2011
    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 SponsorFundación para la Investigación Biomédica del Hospital Gregorio Marañón
    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 supportTo be requested to Health Ministry
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundacion para la investigacion bioMedica del Hospital Gregorio Marañon
    B.5.2Functional name of contact pointresponsable ucaicec
    B.5.3 Address:
    B.5.3.1Street AddressC/ Doctor Esquerdo,46
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28007
    B.5.3.4CountrySpain
    B.5.4Telephone number34914265115
    B.5.5Fax number34914008156
    B.5.6E-mailucaicec@fibhgm.org
    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 DIPRIVAN 1%, jeringa precargada
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA FARMACEUTICA SPAIN, S.A.
    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 Emulsion 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 INNPROPOFOL
    D.3.9.1CAS number 2078-54-8
    D.3.9.3Other descriptive namePROPOFOL
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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 ULTIVA 5 mg polvo para concentrado para solución inyectable o perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXOSMITHKLINE, S.A.
    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 Concentrate and solvent for 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 INNREMIFENTANILO HIDROCLORURO
    D.3.9.3Other descriptive nameREMIFENTANIL HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Patients requiring general anesthesia in whom the control of the airway is usually done with a supraglottic device.
    Pacientes que precisan anestesia general en los que el control de la vía aérea se realiza habitualmente con un dispositivo supraglótico.
    E.1.1.1Medical condition in easily understood language
    general anesthesia
    anestesia general
    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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10018061
    E.1.2Term General anesthesia
    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 determine the clinical concentrations of propofol required for insertion of the LMA-Supreme and examine to what extent the association of remifentanil modifies the concentration of propofol required for insertion.
    Determinar las concentraciones clínicas requeridas de propofol para la inserción de la ML-Supreme y examinar en qué medida la asociación de remifentanilo modifica la concentración de propofol requerida para su inserción.
    E.2.2Secondary objectives of the trial
    -To compare the hemodynamic response to insertion of the LMA-Supreme between the two anesthetics groups: propofol + saline vs. propofol-remifentanil.
    -Compare the response in the parameters of depth of anesthesia (BIS: bispectral index) to the insertion of the LMA-Supreme under the effects of propofol + saline vs. propofol-remifentanil.
    -Compare the oxygenation parameters between the two anesthetic techniques.
    -Comparar la respuesta hemodinámica durante la inserción de la ML-Supreme entre los dos grupos anestésicos: propofol+salino vs. propofol-remifentanilo.
    -Comparar la respuesta en los parámetros de profundidad anestésica (BIS: índice biespectral) ante la inserción de la ML-Supreme bajo los efectos de propofol+salino vs. propofol-remifentanilo.
    -Comparar los parámetros de oxigenación entre las dos técnicas anestésicas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Los pacientes podrán ser incluidos en el estudio siempre que cumplan los criterios indicados a continuación:
    pacientes ASA I y II,
    con edades entre 18-75 años,
    que vayan a ser intervenidos mediante cirugía ambulatoria realizada habitualmente con mascarilla laríngea: procedimientos menores de cirugía vascular, abdominal, plástica, urológica y de cirugía ortopédica menor.
    E.4Principal exclusion criteria
    Parámetros de vía aérea difícil,
    patología de la columna cervical,
    disminución de la apertura bucal menor de 2,5 cm,
    antecedentes de reflujo gastroesofágico,
    hiperreactividad bronquial,
    antecedentes de infección respiratoria reciente.
    Mujeres embarazadas o en periodo de lactancia: las mujeres en edad fértil deberán tener una prueba de embarazo negativo en el momento de la inclusión en el estudio y las mujeres menopáusicas deben presentar amenorrea al menos 12 meses antes de la inclusión en el estudio
    Negativa del paciente a participar en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - Variables demográficas: Edad, género, peso, talla, IMC
    - Variables clínicas: Índice ASA
    - Enfermedades Concomitantes: Presencia de enfermedades de tipo cardiovascular, respiratorio, insuficiencia hepática, insuficiencia renal, antecedentes de reflujo esofágico.
    - Cirugía que se va a realizar
    - Parámetros de vía aérea difícil:
    o Test de Mallampati
    o Distancia tiromentoniana
    o Movilidad cervical
    - Concentración plasmática de propofol TCI en la que se realiza la colocación de la ML-Supreme
    - Parámetros hemodinámicos basales y cada tres minutos hasta 6 minutos después de insertar la ML-Supreme
    - Valores del BIS basales y cada minuto hasta 6 minutos después de insertar la ML-Supreme
    E.5.1.1Timepoint(s) of evaluation of this end point
    since insertion till 6 minutes after insertion
    desde el momento e la insercion y hasta minutos despues de la insercion
    E.5.2Secondary end point(s)
    Variables demográficas: Edad, género, peso, talla, IMC
    - Variables clínicas: Índice ASA
    - Enfermedades Concomitantes: Presencia de enfermedades de tipo cardiovascular, respiratorio, insuficiencia hepática, insuficiencia renal, antecedentes de reflujo esofágico.
    - Cirugía que se va a realizar
    - Parámetros de vía aérea difícil:
    o Test de Mallampati
    o Distancia tiromentoniana
    o Movilidad cervical
    - Concentración plasmática de propofol TCI en la que se realiza la colocación de la ML-Supreme
    - Parámetros hemodinámicos basales y cada tres minutos hasta 6 minutos después de insertar la ML-Supreme
    - Valores del BIS basales y cada minuto hasta 6 minutos después de insertar la ML-Supreme
    Variables demográficas: Edad, género, peso, talla, IMC
    - Variables clínicas: Índice ASA
    - Enfermedades Concomitantes: Presencia de enfermedades de tipo cardiovascular, respiratorio, insuficiencia hepática, insuficiencia renal, antecedentes de reflujo esofágico.
    - Cirugía que se va a realizar
    - Parámetros de vía aérea difícil:
    o Test de Mallampati
    o Distancia tiromentoniana
    o Movilidad cervical
    - Concentración plasmática de propofol TCI en la que se realiza la colocación de la ML-Supreme
    - Parámetros hemodinámicos basales y cada tres minutos hasta 6 minutos después de insertar la ML-Supreme
    - Valores del BIS basales y cada minuto hasta 6 minutos después de insertar la ML-Supreme
    E.5.2.1Timepoint(s) of evaluation of this end point
    since insertion till 6 minutes after insertion
    desde el momento e la insercion y hasta minutos despues de la insercion
    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 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 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 No
    E.8.1.4Double blind Yes
    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
    suero salino
    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 Information not present in EudraCT
    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
    last patient last visit
    ultima visita ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months3
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-09-20. Yes
    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 state50
    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 different from expected
    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 Decision2011-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-03
    P. End of Trial
    P.End of Trial StatusOngoing
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