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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:2011-000329-66
    Sponsor's Protocol Code Number:HS/EC2010004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-01-24
    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 number2011-000329-66
    A.3Full title of the trial
    ?ENSAYO CLÍNICO ALEATORIZADO: SEDACIÓN EN PROCEDIMIENTOS ENDOSCÓPICOS KETAMINA VERSUS PROPOFOL?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NO
    A.3.2Name or abbreviated title of the trial where available
    NO
    A.4.1Sponsor's protocol code numberHS/EC2010004
    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 SponsorAna Vallejo de la Cueva
    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 supportAna Vallejo de la Cueva
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationno
    B.5.2Functional name of contact pointno
    B.5.3 Address:
    B.5.3.1Street Addressno
    B.5.3.2Town/ cityno
    B.5.3.3Post codeno
    B.5.3.4CountrySpain
    B.5.4Telephone numbernononono
    B.5.5Fax numbernononono
    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 Ketolar 50 mg / ml
    D.2.1.1.2Name of the Marketing Authorisation holderParke Davis, S.L
    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 Yes
    D.2.5.1Orphan drug designation numberno
    D.3 Description of the IMP
    D.3.1Product nameKetamina
    D.3.2Product code 47034
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravascular use (Noncurrent)
    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.3.9.2Current sponsor code6740-88-1
    D.3.9.3Other descriptive name6740-88-1
    D.3.9.4EV Substance CodeSUB08365MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 2
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberno
    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 Yes
    D.3.11.13.1Other medicinal product typeno
    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 Propofol-Lipurol 1%
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Melsungen AG
    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 Yes
    D.2.5.1Orphan drug designation numberno
    D.3 Description of the IMP
    D.3.1Product namePropofol
    D.3.2Product code 62953
    D.3.4Pharmaceutical form Emulsion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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.3.9.2Current sponsor code2078-54-8
    D.3.9.3Other descriptive namen2078-54-8
    D.3.9.4EV Substance CodeSUB10116MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.5 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 Yes
    D.3.11.3.5.1CAT classification and reference numberno
    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 Yes
    D.3.11.13.1Other medicinal product typeno
    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
    Anestesia y
    procedimientos afines
    E.1.1.1Medical condition in easily understood language
    no
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10002323
    E.1.2Term Anesthesia general
    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
    Analizar el perfil de seguridad la ketamina vs propofol en los procedimientos endoscópicos
    E.2.2Secondary objectives of the trial
    Analizar los tiempos de sedación y de recuperación de la misma.
    Valorar el grado de satisfacción tanto del intensivista como del médico gastroenterólogo.
    Valorar el grado de satisfacción del paciente
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    no
    E.3Principal inclusion criteria
    Pacientes mayores de 18 años,
    Pacientes sometidos a un PE bajo sedación.
    Con riesgo anestésico I, II, III o IV
    Que acepten participar en el estudio de forma voluntaria y que firmen el consentimiento informado (CI) específico.
    E.4Principal exclusion criteria
    Pacientes con incapacidad para firmar el CI.
    Pacientes con enfermedad coronaria severa.
    Pacientes con arteriopatía periférica severa.
    Pacientes con hipertensión arterial maligna o refractaria al tratamiento
    Pacientes con hipersensibilidad a la ketamina o propofol o alguno de sus componentes.
    Embarazo.
    Periodo de lactancia.
    No comprometerse tanto el hombre como la mujer a usar anticonceptivos de alta eficacia antes del inicio y 3 meses después del final de tratamiento.

    E.5 End points
    E.5.1Primary end point(s)
    PERFIL DE SEGURIDAD 1. Presencia de desaturación: Existencia durante el procedimiento de
    descenso de la saturación de oxigeno por pulsioximetria (Sp02) por debajo del 90%. 2. Complicación en
    la vía aérea: Necesidad durante el procedimiento de tracción mandibular, hiperextensión del cuello,
    ventilación con bolsa autoinflable-mascarilla, cánula oro-faríngea, o intubación orotraqueal, por pérdida
    del tono orofaríngeo y obstrucción de la vía aérea superior. 3. Hipotensión: Presencia durante el
    procedimiento de una tensión arterial media (TAM) inferior a 60 mmHg o una tensión arterial sistólica
    (TAS) inferior a 85 mm Hg). 4. Ingreso en UCI: Necesidad de ingresar al paciente en la unidad de
    cuidados intensivos tras el procedimiento por la existencia de complicaciones durante el mismo. 5.
    Perforación digestiva: Disrupción de la pared intestinal, con presencia de neumomediastino o
    neumoperitoneo y/o contenido intestinal. 6. Arritmias: Aparición durante el procedimiento endoscópico
    de alteraciones del ritmo cardíaco, en forma de bradicardia sinusal (menos de 45x´), taquicardia
    supraventricular (TSV), taquicardia ventricular (TV), fibrilación ventricular (FV), bloqueo
    auriculoventricular (BAV), y fibrilación auricular (FA). 7. Exitus: Fallecimiento del paciente durante la
    realización de la endoscopia, o como consecuencia de una complicación del mismo. 4.3.2.TIEMPOS
    DE SEDACIÓN Y RECUPERACIÓN DE LA SEDACIÓN 1. Tiempo de sedación total: Variable
    cuantitativa medida en minutos. En el caso de la ketamina incluye el periodo de tiempo que se prolonga
    entre la primera dosis de ketamina o bolo de propofol hasta que el paciente es capaz de abrir los ojos y
    obedecer órdenes sencillas. 2. Tiempo de recuperación: Variable cuantitativa medida en minutos que
    incluye el periodo de tiempo desde que se administra la última dosis de ketamina, o se suspende la
    perfusión del propofol, hasta que el paciente es capaz de abrir los ojos y obedecer órdenes sencillas.
    4.3.3.VALORACIÓN GRADO DE SATISFACCIÓN DEL INTENSIVISTA 1. Encuesta de
    satisfacción 2. Escala de sedación cualitativa 3. Escala de analgesia cuantitativa en pacientes sedados
    (Campbell) 4. Colaboración del paciente 4.3.3.1Encuesta de satisfacción (grado de satisfacción con
    respecto a la droga usada)17.Variable cualitativa y graduada en: 1. Muy buen fármaco 2. Buen fármaco
    3. Aceptable 4. No aconsejable 5. Nunca más lo utilizaría 4.3.3.2Escala de sedación del paciente17:
    Variable cualitativa y graduada en: 1. Paciente despierto y agitado 2. Despierto pero no agitado 3. Ojos
    abiertos 4. Ojos cerrados pero obedece a órdenes 5. Ojos cerrados, responde mínimamente a estímulos
    físicos 6. No responde a estímulos. 4.3.3.3 Escala de analgesia para pacientes con sedación profunda o
    que no pueden expresarse correctamente. Variable cuantitativa. Valora la presencia del dolor y
    cuantificar su intensidad. Consiste en observar el comportamiento del paciente y según la contracción
    de la musculatura facial, el tono muscular, la tranquilidad, la respuesta verbal y la confortabilidad del
    paciente asignar una puntuación (ver anexo B). Su graduación del dolor del 1 al 10 la hace equiparable a
    las escalas usadas en los pacientes conscientes, de esta manera una puntuación de 0 es ausencia del
    dolor, de 1 a 3 dolor leve moderado, de 4 a 6 dolor moderado grave, y más de 6 un dolor muy
    importante 18.
    E.5.1.1Timepoint(s) of evaluation of this end point
    no
    E.5.2Secondary end point(s)
    no
    E.5.2.1Timepoint(s) of evaluation of this end point
    no
    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 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.6.13.1Other scope of the trial description
    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 Yes
    E.7.1.3.1Other trial type description
    no
    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 Yes
    E.8.1.7.1Other trial design description
    no
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    no
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Spain
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days3
    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: 822
    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 No
    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 state822
    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)
    no
    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 Decision2011-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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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