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    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   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:2010-019420-31
    Sponsor's Protocol Code Number:no sponser
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-02-10
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2010-019420-31
    A.3Full title of the trial
    ‘The influence of MAC values and behaviour of a child on emergence delirium after sevoflurane anaesthesia’
    A.4.1Sponsor's protocol code numberno sponser
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    D. IMP Identification
    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
    ‘Emergence delirium’ (ED) is described as a mental disorder during recovery from general anaesthesia. After the introduction of new inhalation anaesthetics such as sevoflurane, this phenomenon again gained prominence. The specific cause is unknown. Objective of the research
    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
    The primary research inquiry being raised concerns anaesthesia related causes:
    Is it possible that adapting an amount of sevoflurane, from 1 MAC (minimum alveolar concentration) (2,5 vol%) to ½ MAC (1,25 vol%) in an MRI scan can reduce the frequency and gravity of ‘emergence delirium’?
    E.2.2Secondary objectives of the trial
    The secondary research inquiry being raised concerns patient related causes:
    Are parents’ and children’s anxiety at induction, as well as their behaviour, a predictive value for the appearance of ‘ED’?
    In case a significant ‘ED’ appears, can this lead to an increase of behavioural disorders at 1 day, 1 week and 2 weeks after intervention?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    b. Inclusion criteria
    1. age between 1,5-6 years old
    2. written permission (informed consent)
    3. no premedication
    4. children who have to undergo a diagnostic MRI scan
    5. ASA status 1-2
    6. parents who speak Dutch
    7. parent present at induction
    E.4Principal exclusion criteria
    1. cognitive or emotional development disorder (with exception of ’attention deficit hyperactivity disorder’ (ADHD))
    2. use of active ingredients (AI) which influence the central nervous system (anticonvulsants)
    3. those who run the risk of developing malignant hyperthermia
    4. hypersensitivity to the inhalation anaesthetic sevoflurane and to propofol
    5. need for premedication
    E.5 End points
    E.5.1Primary end point(s)
    Main study parameters/endpoints: The primary endpoints are the maximum scores on the ‘Pediatric Anesthesia Emergence Delirium Scale’ (PAED) until 1 hour after having stopped the administration of the anaesthetic. We consider a score of >10 on the PAED scale as cut-off for the presence or absence of ED. The secondary endpoints are the time between terminating the administration and the removal of the laryngeal mask airway and the time of reaction (‘responsiveness’) to light or gentle tactile stimulation.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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
    observational
    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) No
    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 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
    different doses of sevoflurane
    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 Information not present in EudraCT
    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
    After randomisation the children are divided in two groups (stratification according to age).
    Group A sevoflurane 1 MAC (2,5 vol.%) (13)
    Group B sevoflurane 0,5 MAC (1,25 vol.%) (14, 27-28)
    Further division in age group
    1. >1,5 year old < 4 years old 2 x 10 children
    2. >4 years old < 6 years old 2 x 10 children
    This trial will be finisched when 40 patients have been included.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    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 Yes
    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) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    At that moment, information will be given to the parents or legal representatives about the content and the goal of this study. It are the parents who will give authorization.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 40
    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 Decision2011-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-22
    P. End of Trial
    P.End of Trial StatusOngoing
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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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