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    Summary
    EudraCT Number:2019-002848-24
    Sponsor's Protocol Code Number:IFT2019
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-01-29
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2019-002848-24
    A.3Full title of the trial
    Brain functional signature of connected consciousness under general anesthesia using the isolated forearm technique
    Signature fonctionnelle cérébrale de la conscience connectée à l’environnement au cours d’une anesthésie générale avec la technique de l’avant-bras isolé
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Brain functional signature of connected consciousness under general anesthesia
    Signature fonctionnelle cérébrale de la conscience connectée à l’environnement au cours d’une anesthésie générale
    A.3.2Name or abbreviated title of the trial where available
    IFT_fMRI
    A.4.1Sponsor's protocol code numberIFT2019
    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 SponsorGIGA-Consciousness Thematic Unit, Anesthesia and Intensive Care Laboratory, Liege University
    B.1.3.4CountryBelgium
    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 supportFonds Léon Fredericq
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportSARB Research Grant
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportCrédits Sectoriels de Recherche en Sciences de la Santé 2019 - Fonds Spéciaux pour la Recherche
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGIGA-Consciousness Thematic Unit, Anesthesia and Intensive Care Laboratory, Liege University
    B.5.2Functional name of contact pointVincent Bonhomme
    B.5.3 Address:
    B.5.3.1Street AddressBoulevard du Douzième de Ligne 1
    B.5.3.2Town/ cityLiège
    B.5.3.3Post code4000
    B.5.3.4CountryBelgium
    B.5.4Telephone number32043217117
    B.5.6E-mailvincent.bonhomme@chuliege.be
    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 Propolipid
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi nv
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 namePropolipid
    D.3.2Product code SUB10116MIG
    D.3.4Pharmaceutical form Emulsion for injection/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.3.8INN - Proposed INNPropofol
    D.3.9.3Other descriptive namePROPOFOL
    D.3.9.4EV Substance CodeSUB10116MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma Trading Limited
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameUltiva
    D.3.2Product code SUB10272MIG
    D.3.4Pharmaceutical form Concentrate for 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.3.8INN - 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 mg milligram(s)
    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: 3
    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 Rocuronium
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Melsungen AG
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameRocuronium
    D.3.2Product code SUB10353MIG
    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 INNRocuronium
    D.3.9.3Other descriptive nameROCURONIUM BROMIDE
    D.3.9.4EV Substance CodeSUB10353MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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: 4
    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 Bridion
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameBridion
    D.3.2Product code SUB32205
    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 INNSugammadex
    D.3.9.1CAS number 343306-79-6
    D.3.9.3Other descriptive nameSUGAMMADEX SODIUM
    D.3.9.4EV Substance CodeSUB32205
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Healthy volunteers
    Volontaires sains
    E.1.1.1Medical condition in easily understood language
    Healthy volunteers
    Volontaires sains
    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
    Our study aims at comparing functional connectivity and effective connectivity in networks that are known to participate in the generation of mental content (such as the Default-Mode network, the Executive Control networks, the Salience network, sensory networks and sensorimotor networks), as well as spatial and temporal dynamics of between brain regions interactions, and network topology. Awake subjects, anesthetized unconscious subjects, and anesthetized subjects who recover connected consciousness after a noxious stimulation will be compared.
    Le but de cette étude est de comparer la connectivité fonctionnelle et effective au sein des réseaux corticaux qui sont connus pour participer à la génération du contenu conscient chez l’humain, ainsi que les dynamiques spatiales et temporelles au sein de ces réseaux, et leurs topologies. Des volontaires éveillés, anesthésiés inconscients et des volontaires anesthésies dans un état de conscience connectée après une stimulation nociceptive seront comparés.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial is to compare the cognitive profile and the presence of implicit or explicit memorization between volunteers unconscious anesthetized and volunteers in connected consciousness state under general anesthesia.
    L'objectif secondaire de cette étude est de comparer le profil cognitif et la présence de mémorisation implicite ou explicite entre les volontaires inconscients anesthésiés et les volontaires en état de conscience connectée sous anesthésie générale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age: 18 - 30 years old
    - Right-handed
    - Healthy volunteer: ASA = 1
    - Age: 18 - 30 ans
    - Droitier
    - Volontaires sains: ASA = 1
    E.4Principal exclusion criteria
    o Magnetic resonance imaging contraindications (vascular clips, metallic implants)
    o Women of childbearing age with a suspicion of inadequate contraception
    o Previous brain trauma
    o Previous neurosurgical operation
    o Previous psychiatric disease
    o Recurrent nightmares
    o Addiction
    o Asthma
    o Vertigo
    o History of complications after general anesthesia (post-operatory nausea and vomiting, allergy)
    o Volunteer who participated to previous anesthesia studies conducted by the GIGA-Consciousness unit
    o Contre-indications à l’IRM (clips vasculaires, implants métalliques)
    o Suspicion de contraception inadéquate si femme
    o Antécédents de trauma cérébral
    o Antécédents d’interventions neurochirurgicales
    o Antécédents de maladies psychiatriques
    o Cauchemars récurrents
    o Addiction
    o Asthme
    o Vertiges
    o Histoire de complications après une anesthésie (NVPO, allergie)
    o Le volontaire a déjà participé à une des études d'anesthésie du GIGA-Consciousness
    E.5 End points
    E.5.1Primary end point(s)
    Identify changes of functional connectivity within and between conscious networks associated with connected consciousness during general anesthesia.
    Identifier les changements de connectivité fonctionnelles au sein et entre les réseaux de la conscience associés à l'état de conscience connectée sous anesthésie générale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Mesure of the end point after acquisition and processing the data of functional magnetic resonance imaging of the volunteers in four different resting state:
    - awake
    - unconscious anesthetized
    - state of connected consciousness under general anesthesia
    - recovery
    Mesure de la connectivité cérébrale après acquisition et traitement des données de l'imagerie par résonance magnétique fonctionnelle chez les volontaires dans quatre états différents stables:
    - éveillés
    - inconscients anesthésiés
    - les volontaires en état de conscience connectée sous anesthésie générale
    - lors de la phase de récupération de l'anesthésie
    E.5.2Secondary end point(s)
    Identification of effective connectivity, spatio-temporal interaction and topology changes within and between conscious networks.

    The evaluation of the cognitive profile will be done through three different scales:
    - The Dissociative Experiences Scale wich is a validated evaluation of the presence of Dissociative Identity Disorder.
    - The Tellegen Absorption Scale wich is a measure of absorption.
    - The 5-Dimensional Altered States of Consciousness Rating Scale which is a reliable measure of alterations from normal waking consciousness.

    Explicit memorization will be evaluated with the modified Brice questionnaire.
    Implicit memorization will be evaluated with the two-alternative forced choice signal detection method.
    Identification des changements de connectivité effective, des interactions spatio-temporelles, des changements de topologies au sein et entre les réseaux de la conscience.

    L'évaluation du profil cognitif sera réalisé grâce à trois échelles différentes:
    - La Dissociative Experiences Scale qui est une évaluation validée de la présence de Dissociative Identity Disorder.
    - La Tellegen Absorption Scale qui est une mesure de l'absorption.
    - La 5-Dimensional Altered States of Consciousness Rating Scale qui est une mesure fiable d'alterations d'une conscience et d'un état d'éveil normal.

    La mémorisation explicite sera évaluée grâce au questionnaire de Brice modifié.
    La mémorisation implicite sera évaluée grâce à une méthode de choix forcé à deux alternatives.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Mesure of the end point after acquisition and processing the data of functional magnetic resonance imaging of the volunteers in four different resting state:
    - awake
    - unconscious anesthetized
    - state of connected consciousness under general anesthesia
    - recovery

    The Dissociative Experiences Scale and the Tellegen Absorption Scale will be completed just before general anesthesia.
    The 5-Dimensional Altered States of Consciousness Rating Scale and the two-alternative forced choice signal detection method will be completed 1 hour after recovery from general anesthesia.
    The modified Brice questionnaire will be completed 1 hour, 24 hours and 7 days after recovery from general anesthesia.
    Mesure de la connectivité cérébrale après acquisition et traitement des données de l'imagerie par résonance magnétique fonctionnelle chez les volontaires dans quatre états différents stables:
    - éveillés
    - inconscients anesthésiés
    - les volontaires en état de conscience connectée sous anesthésie générale
    - lors de la phase de récupération de l'anesthésie

    La Dissociative Experiences Scale et la Tellegen Absorption Scale seront complétés juste avant l'anesthésie générale.
    La 5-Dimensional Altered States of Consciousness Rating Scale et la méthode de choix forcé à deux alternatives seront complétés 1 heure après le réveil.
    Le questionnaire de Brice modifié sera complété 1 heure, 24 heures et 7 jours après le réveil.
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Mechanisms of alteration of consciousness induced by anesthetics and mechanisms of the recovery of connected consciousness
    Mécanismes de l'altération de la conscience induite par les agents anesthésiques et les mécanismes de retour à un état de conscience connectée.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    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 Yes
    E.8.1.7.1Other trial design description
    Allocation sequentielle avec deux niveaux de profondeurs d'anesthésie
    Up and down sequential allocation
    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
    Les volontaires non-répondeurs aux commandes verbales sous anesthésie générale
    Non-responder volunteer to verbal command under general anesthesia
    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
    LVLS
    La dernière visite du dernier sujet
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 25
    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 Yes
    F.3.2Patients No
    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 state25
    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
    Aucun
    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 Decision2020-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-29
    P. End of Trial
    P.End of Trial StatusOngoing
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