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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2013-002122-23
    Sponsor's Protocol Code Number:NL44307.078.13
    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:2013-07-10
    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 number2013-002122-23
    A.3Full title of the trial
    The influence of electroencephalographic Narcotrend Index™- guidance of of propofol administration on recovery from procedural sedation for gastrointestinal endoscopy in paediatric patients
    De invloed van Narcotrend Index™ EEG-gestuurde toediening van propofol op het ontwaken na procedurele sedatie voor gastrointestinale endoscopie bij kinderen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Endoscopic examination of the digestive tract in children under sedation with advanced monitoring equipment
    Endoscopisch onderzoek van het spijsverteringssysteem bij kinderen onder sedatie met behulp van moderne apparatuur om de slaapdiepte te meten
    A.3.2Name or abbreviated title of the trial where available
    NI-PPS
    NI-PPS
    A.4.1Sponsor's protocol code numberNL44307.078.13
    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 SponsorErasmus University Medical Center
    B.1.3.4CountryNetherlands
    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 supportErasmus University Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus University Medical Center
    B.5.2Functional name of contact pointPaediatric Anaesthesia - Sophia
    B.5.3 Address:
    B.5.3.1Street AddressDr. Molewaterplein 60
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015GJ
    B.5.3.4CountryNetherlands
    B.5.6E-mailf.weber@erasmusmc.nl
    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 Propofol 10 mg/ml MCT/LCT Fresenius emulsie voor injectie of infusie
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Nederland B.V., Molenberglei 7, 2627 Schelle, BelgieĢˆ
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Solution 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.3.9.1CAS number 2078-54-8
    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 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.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
    There is no medical condition which is under investigation.
    Paediatric patients, scheduled for gastrointestinal endoscopy under procedural sedation are eligible for inclusion.
    Depth of sedation will be assessed either by processed EEG analysis or by clinical surrogate parameters. Based on that assessement propofol is delivered.
    E.1.1.1Medical condition in easily understood language
    Need for an examination of the gut by a doctor
    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 evaluate the impact of electroencephalographic Narcotrend™ Index (NI) monitoring on the speed of emergence and recovery from procedural sedation for paediatric gastrointestinal endoscopy.
    E.2.2Secondary objectives of the trial
    Secondary Objective(s): • Cumulative propofol consumption • Total time from discontinuation of anaesthetic drug delivery until discharge from the post anaesthesia care unit • Posthoc intergroup comparison of hypnotic depth as measured by Narcotrend • Detection of possible recall of events during the procedure (awareness) • Assessment of endoscopy conditions (by paediatric gastroenterologist) • Adverse events • Economic Analysis (Cost minimization analysis, CMA)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Written informed consent of patients and their parents/legal representatives • Age 12-17 years • Bodyweight ≤ 60 kg • Gastrointestinal endoscopy • Eligibility for procedural sedation • Ability of the patient to communicate in Dutch
    E.4Principal exclusion criteria
    Withdrawal of informed consent • Chronic exposure (more than one day) to psychotropic drugs and/or opioids • Known allergy/intolerance for propofol and/or remifentanil • Anticipated difficult airway • Child not eligible for procedural sedation, need for inhalation induction and general anaesthesia • Patient and/or parents unable to communicate in Dutch Secondary exclusion criteria • Unexpected need for inhalation induction of general anaesthesia due to major difficulties to obtain intravenous access. • Unexpected procedural events requiring endotracheal intubation
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is the effect of NI monitoring on the speed of recovery from procedural sedation for paediatric gastrointestinal endoscopy (PGE). Speed of recovery is defined as the time interval between the end of anaesthetic drug application and the moment when discharge criteria from the operating room are met.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Immediately after the endoscopic procedure
    E.5.2Secondary end point(s)
    Cumulative propofol consumption
    • Total time from discontinuation of anaesthetic drug delivery until discharge from the post anaesthesia care unit
    • Posthoc intergroup comparison of hypnotic depth as measured by Narcotrend
    • Detection of possible recall of events during the procedure (awareness)
    • Assessment of endoscopy conditions (by paediatric gastroenterologist)
    • Adverse events
    • Economic Analysis (Cost minimization analysis, CMA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    On the recovery room, interviews 1 and 14 days after the procedure.
    Posthoc analysis of EEG data will be performed offline.
    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
    EEG-based depth of hypnosis (DoH) monitoring during paediatric procedural sedation (PPS) may result in a faster recovery after the procedure, compared to a standard PPS regimen. From a scientific point of view the key question is whether the application of DoH monitoring results in advantages for both the patient and the health care providers (enhanced workflow on the operation room) are big enough to spend some extra money for the DoH-monitoring devices and disposables.
    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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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
    after inclusion of a total of 40 patients (number justified by a-priori power analysis)
    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.1.1Number of subjects for this age range: 40
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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
    Teenagers aged between 12 and 17 years cannot give consent without their parents
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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
    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 Decision2013-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-11
    P. End of Trial
    P.End of Trial StatusOngoing
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