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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   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:2018-001252-35
    Sponsor's Protocol Code Number:DANA-2018-1.
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-06-27
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2018-001252-35
    A.3Full title of the trial
    Neuroplasticity induced by general anaesthesia
    Anæstetikainduceret neuroplasticitet
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Changes in the human brain induced by general anaesthesia
    Forandringer i hjernen efter generel anæstesi
    A.4.1Sponsor's protocol code numberDANA-2018-1.
    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 SponsorKirsten Møller
    B.1.3.4CountryDenmark
    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 supportRigshospitalet
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet
    B.5.2Functional name of contact pointGlostrup
    B.5.3 Address:
    B.5.3.1Street AddressValdemar Hansens Vej 15
    B.5.3.2Town/ cityGlostrup
    B.5.3.3Post code2600
    B.5.3.4CountryDenmark
    B.5.6E-mailsigne.sloth.madsen@regionh.dk
    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 Sevorane, sevoflurane
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter A/S, Tobaksvejen 2A, DK-2860 Søborg
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Inhalation vapour, liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    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 Propofol
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 namePropofol
    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.3.11 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
    This trial investigates the effects of general anaesthesia on the helathy human brain. Thus, only healthy, young adults with no medical conditions will participate as volunteers in this study.
    Dette forsøg involverer kun raske, frivillige, voksne forsøgspersoner.
    E.1.1.1Medical condition in easily understood language
    This trial only involves healthy, young adults, that volunteer to participate.
    Dette forsøg involverer kun raske, frivillige, voksne forsøgspersoner.
    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
    To explore and compare possible the de novo neuroplastic changes (visualised by magnetic resonnance imaging (MRI)) induced by anaesthesia with a volatile agent (sevoflurane) and total intravenous anaesthesia (propofol) respectively.
    At undersøge og sammenligne mulige de novo neuroplastiske forandringer i hjernen (visualiseret ved magnetisk resonans skanning (MR)), som induceres af generel anæstesi med gas (sevofluran) og total intravenøs anæstesi (propofol).
    E.2.2Secondary objectives of the trial
    To elucidate possible associations between MRI findings and clinical as well as biochemical outcomes.
    At belyse mulige sammenhænge mellem MR-fund og kliniske såvel som biokemiske outcomes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥18 and ≤35
    • Healthy individual
    • BMI ≥18 kg/m2 and ≤30kg/m2
    • American Society of Anaesthesiologists (ASA) class 1 (61)
    • Mallampati I-II and simplified airway risk index (SARI) 0-2 (i.e. no indication of difficult intubation). See appendix for details.
    • Female participants must use safe contraceptives (hormonal or mechanical, including IUDs).
    • Speaks and understand Danish
    • Provides oral and written informed consent
    • Alder mellem 18-35 år
    • Rask person
    • Taler og forstår skriftlig og mundtlig dansk
    • Afgiver samtykke til deltagelse efter mundtlig og skriftlig information
    • Ved mundåbning kan alle ganebuerne og drøbelen ses, og der er ingen tegn på vanskeligheder ved luftvejshåndtering ved generel anæstesi (Mallampati I-II and SARI 0-2)
    • BMI mellem 18 kg/m2 -30kg/m2
    • Kvindelige forsøgspersoner skal anvende sikker prævention mod graviditet (hormonel eller mekanisk).
    • Opfylder kriterierne som svarer til American Society of Anesthesiologists (ASA) class 1.
    E.4Principal exclusion criteria
    • Reflux or dyspepsia
    • Poor dental status or oral health
    • Expected or suspected difficult airway
    • Allergy to any kind of medication or material to which the volunteer could be exposed during this study
    • Contraindication to MRI
    • Major trauma or head trauma with any symptoms present at the time of inclusion
    • Surgery less than six weeks prior to the study period
    • Infection (with fever) less than two weeks prior to or during the study period
    • History of complications to general anaesthesia
    • Family history of malignant hyperthermia
    • Known incident of malignant hyperthermia or unexplained complication to general anaesthesia among close relatives.
    • History of cancer, immune disease, autoimmune disease, chronic pain or neurological / psychiatric illness
    • Daily use of any medication (not counting contraceptives)
    • Consumed anti-depressants during the last 30 days before study days
    • Weakly intake of >21 (for females >14) units of alcohol
    • Substance abuse (assessed by the investigator)
    • Heavy intake of caffeine (> 5 cups/day)
    • Smoking during the last 30 days before study days
    • Declines receiving information regarding accidental pathological findings during MRI scans of the brain.
    • Cannot cooperate to tests
    • Otherwise judged unfit for participation by the investigator

    Exclusion Criteria during the study (leading to withdrawal):
    • Any of the above mentioned exclusion criteria
    • Major trauma or head trauma during the study period
    • Surgery during the study period
    • Infection (with fever) during the study period
    • Consumption of more than 3 units of alcohol within 24 hours before each study day (intervention day or MRI scan day)
    • Consumed analgesics within 3 days before each study day
    • Consumed anti-histamines less than 48 hours before each study day
    • Intake of caffeine 12 h prior to each study day
    • Smoking
    • Kan ikke samarbejde til testning
    • Sygdomshistorie med cancer, immunsygdom, autoimmun sygdom, kroniske smerter, neurologisk sygdom eller psykiatrisk lidelse
    • Ugentligt indtag af alcohol svarende til mere end 21 genstande for mænd eller 14 genstande for kvinder
    • Ethvert misbrug (vurderet af forsøgsansvarlige)
    • Dagligt medicinforbrug af nogen art (fraset prævention)
    • Indtag af antidepressive lægemidler indenfor 30 dage før rekruttering til projektet.
    • Højt indtag af koffein (mere end 5 kopper om dagen)
    • Rygning indenfor 30 dage før studieperiodens start
    • Refluks eller halsbrand
    • Nedsat tandstatus eller sygdomme I munden
    • Tilstande som er til hinder for MR-skanning
    • Allergi overfor enhver slags medicin som forsøgspersonen kan risikere at få I løbet af projektet
    • Afslår at modtage information om tegn på sygdom som måtte findes I forbindelse med MR-skanningerne I løbet af projektet
    • Vurderes af forsøgsansvarlige uegnet til deltagelse
    • Forekomst af malign hypertermi i familien
    • Større traume eller hovedskade som er symptomgivende på inklusionstidspunktet
    • Kirurgi indenfor 6 uger forud for deltagelse i projektet
    • Infektion (med feber) mindre end to uger før projektet
    • Forventet eller mistanke om svær luftvejshåndtering ved generel anæstesi
    • Tidligere komplikationer til general anæstesi
    • Kendte tilfælde af tilstanden malign hyperthermi or eller uafklarede komplikationer til general anæstesi blandt nære familiemedlemmer

    Kriterier for at udgå af studiet:
    • Enhver af ovenstående exklusionskriterier, som måtte indtræffe eller åbenbares i løbet af studiet
    • Indtag af mere end 3 genstande alkohol indenfor 24 timer før hver studiedag (dag med intervention eller MRI scanning)
    • Indtag af smertestillende medicin indenfor 3 dage før hver studiedag
    • Indtag af antihistaminer indenfor 48 timer før hver studiedag
    • Indtag af koffein 12 timer før hver studiedag
    • Rygning
    • Større traume eller hovedtraume i løbet af studieperioden
    • Kirurgi i løbet af studieperioden
    • Infektion (med feber) i løbet af studieperioden
    E.5 End points
    E.5.1Primary end point(s)
    Volume and morphology of selected brain regions and anatomical structures as recorded by T1w3D anatomy MRI, and white matter microstructure as measured using Diffusion Tensor Imaging (DTI).
    Størrelse (volumen) og udseende (morfologi) af udvalgte områder i hjernen, målt ved T1-vægtet 3D anatomiske MR-skanninger, og hvid substans mikrostruktur målt ved Diffusion Tensor Imaging (DTI).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before general anaesthesia (baseline), after general anaesthesia (on the same day), one day after general anaesthesia, and one week (7-10 days) after general anaesthesia.
    Før generel anæstesi (baseline), efter generel anæstesi (samme dag), en dag efter generel anæstesi, og en uge (7-10 dage) efter generel anæstesi.
    E.5.2Secondary end point(s)
    1. Differences in resting state functional MRI (rsfMRI) induced by GA.
    2. Severity and characteristics of of fatigue, as measured by Multidimensional Fatigue Inventory (MFI-20).
    3. Cognitive function including attention, speed and executive function as measured by computer-based neuropsychological tests (Paced Auditory Serial Addition Test(PASAT), Test of Attentional Performance (TAP), and Conners Continuous Performance Test 3rd edition (CPT3)).
    4. Quality of Recovery – 15-item questionnaire.
    5. Immune function and biochemical markers analysed by the following methods: Whole blood gene expression profiling, flow cytometry, in vitro stimulation of peripheral blood mononuclear cells, cytokine immune assays, and organ-specific biochemical markers as described below.
    6. Autonomic nervous system activity as measured using Heart Rate Variability (HRV).
    7. Correlations between MRI findings as well as clinical and biochemical outcomes as described above.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Identical with primary end points.
    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 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 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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other 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 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.8.5The 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 visit of last volunteer.
    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 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: 30
    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 state30
    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)
    Only healthy volunteers are included. Thus, no treatment is planed after the subject has ended the participation in the trial.
    Kun raske, frivillige, voksne forsøgspersoner involveres i dette studie. Der er således ikke planlagt nogen form for behandling efter endt deltagelse i studiet.
    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 Decision2018-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-08-13
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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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