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    Summary
    EudraCT Number:2016-002824-98
    Sponsor's Protocol Code Number:ANE_HEPUNOX
    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:2016-08-11
    Trial results View 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 number2016-002824-98
    A.3Full title of the trial
    Comparison of three techniques in the management of the postoperatory acute pain, after a general anesthesia based on the control of the nociception.
    Comparación de tres técnicas en el manejo del dolor agudo postoperatorio, después de una anestesia general guiada en base al control de la nocicepción.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of three techniques in the management of the postoperatory acute pain, after a general anesthesia based on the control of the nociception
    Comparación de tres técnicas en el manejo del dolor agudo postoperatorio, después de una anestesia general guiada en base al control de la nocicepción.
    A.4.1Sponsor's protocol code numberANE_HEPUNOX
    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 SponsorFundació Hospital Vall Hebron Institut de Recerca
    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 supportFundació Hospital Vall Hebron Institut de Recerca
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario Vall Hebron - Servicio de Anestesiología y Reanimación
    B.5.2Functional name of contact pointDra. Ana M. Abad Torrent
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Vall Hebron, 119-129
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number0034934893000
    B.5.6E-mailaat23865@yahoo.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 Ultiva
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    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 Powder for concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNREMIFENTANIL
    D.3.9.1CAS number 132875-61-7
    D.3.9.4EV Substance CodeSUB10272MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    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.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
    Acute postoperative pain
    Dolor agudo postoperatorio
    E.1.1.1Medical condition in easily understood language
    Acute postoperative pain
    Dolor agudo postoperatorio
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10002323
    E.1.2Term Anesthesia general
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assay if the monitoring of intraoperative analgesia through pupilometry (AlgiScan) or guided by electroencephalography (qNOX) compared with the standar hemodynamics monitoring improves the conduction of the general anesthesia and the management of post-surgery acute pain.
    Valorar si la monitorización intraoperatoria de la analgesia mediante pupilometría (AlgiScan) o guiada por electroencefalografía (qNOX) en comparación con la monitorización hemodinámica estándar mejora la conducción de la anestesia general y el manejo del dolor agudo en el postoperatorio.
    E.2.2Secondary objectives of the trial
    - To compare the efficacy of intraoperative analgesia monitoring through pupilometry ( AlgiScan ) versus electroencephalography ( qNOX ) .
    - To demostrate that the number of analgesics needed by the patient during the postoperative period is less in those which have been subjected to intraoperative monitoring with pupilometry or qNOX in comparation with the group that the intraoperative analghesia has been controlled with hemodynamic criteria
    - Comparar la eficacia de la monitorización intraoperatoria de la analgesia mediante pupilometría (AlgiScan) versus la electroencefalografía (qNOX).
    - Demostrar que el número de analgésicos que precisan los pacientes durante el postoperatorio es menor en aquellos a las que se les ha realizado monitorización intraoperatoria con pupilometría o qNOX en comparación al grupo que se ha controlado la analgesia intraoperatoria a partir de variaciones hemodinámicas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with ages between 18-75 years.
    - ASA I-II-III.
    - Body mass index (BMI ) less than 35 kg / m2 for women and 42 kg / m2 in men.
    - Major gynecological surgery abdominal hysterectomy laparoscopic or robotic radical prostatectomy.
    - Control Technology -TCI general anesthesia TIVA (total intravenous anesthesia by infusion systems controlled by computer).
    - Patients enroll in other clinical investigations can participate
    -Pacientes con edades comprendidas entre 18-75 años.
    -ASA I-II-III.
    -Índice de masa corporal (IMC) menor de 35 Kg/m2 en mujeres y 42 Kg/m2 en hombres.
    -Cirugía mayor ginecológica de histerectomía abdominal mediante laparoscopia o prostatectomía radical robótica.
    -Técnica de anestesia general TIVA -TCI (anestesia total intravenosa mediante sistemas de infusión controlados por ordenador).
    -Los pacientes podrán participar en otras investigaciones clínicas.
    E.4Principal exclusion criteria
    - Patients who do not accept their participation in this clinical trial.
    - Patients who do not have legal capacity.
    - Morbid obesity (BMI > 35 kg / m2 in women and > 42 kg / m2 in men).
    - Basal values ​​of systolic blood pressure ≤ 95 mmHg or a heart rate ≤ 60x ' .
    -Disorders of conduct or anxiety-depressive syndrome.
    - Treatment with chronic psychotropic drugs or opiates.
    - Pregnancy
    - Background Of alcohol abuse .
    - Documented allergy to morphic drugs , paracetamol, metamizol and dexketoprofen.
    - Visual secondary alterations to neurological pathologies, retinopatía diabetic and surgery or anomalies of the iris.
    - Neurological impairment at the level of the midbrain.
    -Pacientes que no acepten su participación en este ensayo clínico.
    -Pacientes que no tengan capacidad legal.
    -Obesidad mórbida (IMC > 35 Kg/m2 en mujeres y > 42 Kg/m2 en hombres).
    -Valores de tensión arterial sistólica basal ≤ a 95 mmHg o frecuencia cardíaca ≤ a 60x'.
    -Trastornos de conducta o síndrome ansioso-depresivo.
    -Tratamiento crónico con psicofármacos u opiáceos.
    -Embarazo.
    -Antecedentes de enolismo.
    -Alergia documentada a mórficos, paracetamol, metamizol y dexketoprofeno.
    -Alteraciones visuales secundarias a patologías neurológicas, retinopatía diabética y cirugía o anomalías del iris.
    -Afectación neurológica a nivel de mesencéfalo.
    E.5 End points
    E.5.1Primary end point(s)
    - Pupillometry (RDP ) : pupillary diameter in mm . Constant quantitative variable
    - qNOX: Index adimensional. Constant quantitative variable
    - Remifentanil dose
    - Non invasive Blood Pressure
    - Heart Rate (FC)
    - Pupilometría (RDP): Diámetro pupilar en mm. Variable continua cuantitativa
    - qNOX: Índice adimensional. Variable continua cuantitativa
    - Dosis de Remifentanil
    - Tensión arterial no invasiva
    - Frecuencia cardíaca



    E.5.1.1Timepoint(s) of evaluation of this end point
    Continously during the surgery procedure
    De forma continua durante del procedimiento quirúrgico
    E.5.2Secondary end point(s)
    - Dose of propofol
    - Demographic data
    - Biometric data
    - Duration of the surgery
    - Duration of the anesthesia
    - Acute postoperative pain
    -Dosis de propofol
    - Datos demográficos
    - Datos biométricos
    - Duración de la cirugía
    - Duración de la anestesia
    - Dolor agudo postquirúrgico
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Demographic data; Biometric data: beggining of the trial
    - Duration of the surgery; Dose of propofol; Duration of the anesthesia: during the surgery procedure
    - Acute postoperative pain : at different timepoints until complete 12 hours follow-up.
    - Datos demográficos; Datos biométricos: al inicio del estudio
    - Duración de la cirugía; Dosis de propofol ; Duración de la anestesia: durante el proceso quirúrgico
    - Dolor agudo post quirúrgico: en diferentes tiempos hasta un máximo de 12 de horas de seguimiento
    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.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 Yes
    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 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
    3 técnicas diferentes para comparar el dolor agudo post-operatorio
    3 differents techiniques for comparing post-surgery acute pain
    E.8.2.4Number of treatment arms in the trial3
    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
    Last Patient Last Visit
    Último Paciente última visita
    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 months15
    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: 154
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 2016-08-11. 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 state204
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-12-04
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