Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-002102-37
    Sponsor's Protocol Code Number:ORL-CENS-2015
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-07-31
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-002102-37
    A.3Full title of the trial
    Open randomized clinical trial to compare the efficacy of hypotensive anesthesia with clonidine or dexmedetomidine during endoscopic nasal surgery
    Ensayo clínico aleatorizado abierto para comparar la eficacia de la anestesia hipotensiva con clonidina o dexmedetomidina durante la cirugía endoscópica nasal
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparative study of the efficacy of clonidine and dexmetomidina in nasal endoscopic surgery anaesthesia
    Estudio comparativo de la eficacia de clonidina y dexmetomidina en la anestesia de la cirugía endoscópica nasal
    A.4.1Sponsor's protocol code numberORL-CENS-2015
    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 Parc Taulí
    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 Parc Taulí
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Parc Taulí
    B.5.2Functional name of contact pointOficina de recerca
    B.5.3 Address:
    B.5.3.1Street AddressParc Taulí 1
    B.5.3.2Town/ citySabadell
    B.5.3.3Post code08208
    B.5.3.4CountrySpain
    B.5.4Telephone number(+34)93 7458451
    B.5.5Fax number(+34)93 7175067
    B.5.6E-mailafarre@tauli.cat
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameclonidine
    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 INNCLONIDINE
    D.3.9.1CAS number 4205-90-7
    D.3.9.4EV Substance CodeSUB06730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.15
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namedexmedetomidina
    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 INNDEXMEDETOMIDINE
    D.3.9.1CAS number 113775-47-6
    D.3.9.4EV Substance CodeSUB07037MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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
    Nasosinusal endoscopic surgery in patients with chronic sinusitis and/or nasal polyposis
    Cirugía endoscópica nasosinusal en pacientes con sinusitis crónica y/o poliposis nasal
    E.1.1.1Medical condition in easily understood language
    Nasosinusal endoscopic surgery
    Cirugía endoscópica nasosinusal
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10009137
    E.1.2Term Chronic sinusitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10028755
    E.1.2Term Nasal polypectomy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare intraoperative bleeding during nasosinusal endoscopic surgery, in patients receiving treatment hypotensive anesthetic based on clonidine or dexmedetomidine as assessed through a modified Boezaart score for surgical field bleeding, evaluated by the external evaluator blinded to the identity of the treatments administered
    Comparar el sangrado del campo quirúrgico durante la cirugía endoscópica nasosinusal (CENS), en pacientes que reciben tratamiento anestésico hipotensivo basado en clonidina o en dexmedetomidina mediante la estimación realizada con la escala de Boezaart del sangrado del campo quirúrgico modificada, evaluada por el evaluador externo ciego a la identidad de los tratamientos administrados
    E.2.2Secondary objectives of the trial
    - Surgical field bleeding through the estimates of the amount of blood
    aspirated during the intervention in mL, according to an hemoglobin
    correction formula
    - Surgical field bleeding through the subjective assessment of the
    intensity of bleeding during surgery by the surgeon
    - Surgical field bleeding through the subjective assessment of the
    intensity of bleeding during surgery by an external observer blinded to
    treatment identity
    - Duration of the anesthesia and of the surgical procedure
    - Complications post-procedure (hematoma or orbital emphysema,
    cerebrospinal fluid leaks, heavy bleeding, etc.)
    - Time to hospital discharge after surgery
    - Sangrado del campo quirúrgico mediante la estimación de la cantidad de sangre aspirada durante la intervención en mL, según fórmula de corrección de hemoglobina en aspirado.
    - Sangrado del campo quirúrgico mediante la estimación de la intensidad del sangrado durante la cirugía por escalas subjetivas evaluadas por el cirujano.
    - Sangrado del campo quirúrgico mediante la estimación de la intensidad del sangrado durante la cirugía por escalas subjetivas evaluadas por el evaluador externo ciego a la identidad de los tratamientos
    - Duración de la cirugía CENS y de la anestesia correspondiente
    - Complicaciones postoperatorias (hematoma o enfisema orbitarios,
    fístulas de líquido cefalorraquídeo, sangrado copioso, etc)
    - Tiempo hasta el alta del paciente
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients of age >18 and < 65 years old
    2. Patients with ASA criteria I, II or III
    3. Patients who will undergo nasosinusal endoscopic surgery
    because of chronic infectious sinusitis and/or nasal polyposis
    4. Patients providing their informed consent
    1. Pacientes mayores de 18 años y menores de 65 años.
    2. Pacientes con criterios ASA I, II o III.
    3. Pacientes que vayan a ser sometidos a CENS por patología sinusal crónica; primaria o secundaria, ya sea por poliposis nasal o por sinusopatía crónica infecciosa.
    4. Pacientes que otorguen su consentimiento informado
    E.4Principal exclusion criteria
    1. Patients who have contraindications to the intended nasosinusalendoscopic surgery or to the anaesthesic treatment used in the routine clinical practice of this type of surgery.
    2. Patients with impaired coagulation or who are treated with
    antiaggregants or anticoagulants.
    3. Patients with antecedents of coronary arteriopathy or heart rhytm
    diseases (tachyarhythmias or blockages).
    4. Patients that at the time of surgery show signs of hypovolemia, severe hypotension or signs of heart failure.
    5. Patients with previous cerebro-vascular event.
    6. Patients with chronic treatment with beta-adrenergic blocker agents, or calcium channel blocking agents that have not been withdrawn for a wash-out period equivalent to at least 7 half-lives of the drug before the surgery.
    7. Patients for whom their caring physician considers that participation in the study may be clinically detrimental.
    1. Pacientes con contraindicaciones para someterse a la intervención quirúrgica CENSo para someterse al tratamiento anestésico utilizado en el estudio para la CENS.
    2. Pacientes con trastornos de la coagulación o que reciban tratamiento con medicamentos antiagregantes o anticoagulantes.
    3. Pacientes con historia previa de arteriopatía coronaria o trastornos del ritmo (taquiarrítmias cardiacas o bloqueos).
    4. Pacientes que en el momento de la intervención presenten signos de hipovolemia, hipotensión severa, o signos de insuficiencia cardíaca.
    5. Antecedente de accidente vascular cerebral
    6. Pacientes en tratamiento crónico con bloqueantes adrenérgicos o bloqueantes de los canales del calcio que en el momento de la intervención no hayan superado un periodo de blanqueo apropiado (mínimo de 7 semividas de eliminación).
    7. Pacientes en los que se considere que la participación en el estudio puede suponer un perjuicio clínico, en opinión del médico responsable del cuidado del paciente.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the Boezaart bleeding score from the surgical field where Boezaart scale degrees are defined as follows:
    Grade 1: cadaverous Conditions requiring minimum suction .
    Grade 2 : Minimum unusual bleeding that requires suction.
    Grade 3: Active bleeding that requires frequent suckling .
    Grade 4: Bleeding covers the surgical field after removing the suction and before the instrument can be maneuvered .
    Grade 5: uncontrolled bleeding . Bleeding outside the nostril to remove the suction.
    An average score will be calculated for the scale of Boezaart at different times and reclassified into a dichotomous variable of scant bleeding ( ratings equal or below 2 ) and abundant bleeding (ratings greater than 2 ) for the primary analysis of the study.
    La variable principal será la escala de Boezaart de sangrado del campo quirúrgico, donde los grados de la escala Boezaart quedan definidos de la siguiente manera:
    Grado 1: Condiciones cadavéricas que requieren de mínima succión.
    Grado 2: Sangrado mínimo que requiere de succión infrecuente.
    Grado 3: Sangrado activo que requiere de succión frecuente.
    Grado 4: El sangrado cubre el campo quirúrgico después de retirar la succión y antes de que el instrumento pueda ser maniobrado.
    Grado 5: Sangrado no controlado. Sangrado por fuera de la narina al retirar la succión.
    Se realizará un promedio de la puntuación en la escala de Boezaart a distintos tiempos y se reclasificará en una variable dicotómica de sangrado escaso (puntuaciones iguales o inferiores a 2) y sangrado copioso (puntuaciones superiores a 2) para el análisis principal del estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 60 minutes during the intervention
    Cada 60 minutos durante la intervención.
    E.5.2Secondary end point(s)
    -Intraoperative bleeding estimated in milliliters
    -Assessment of bleeding by both the surgeon and a blind evaluator from the video recording of interventions, every 60 minutes, using the visual analogue scale (VAS ) intensity of the operative field bleeding
    and the Boezaart scale
    -Duration Surgery , defined as time from the start of the intervention by the surgeon to the nasal tampooning .
    -Duration Anesthesia, defined as time from the start of induction to extubation of the patient.
    -Evaluation of Lund - Mackay scale before surgery
    -Postoperative surgical and anesthetic complications
    -Duration of the hospital stay
    -Assessment of bleeding and late complications of surgery at a follow-up outpatient visit one week after surgery.
    -La estimación del sangrado intraoperatorio en mililitros
    -Valoración del sangrado, tanto por el cirujano como por un evaluador ciego a partir de la grabación en video de las intervenciones, cada 60 minutos, mediante escalas:
    o Escala analógica visual (EVA) de intensidad del sangrado del campo operatorio
    o Escala de Boezaart
    -Duración de la cirugía, definida como tiempo desde el inicio de la intervención por parte del cirujano hasta el taponamiento nasal.
    -Duración de la anestesia, definida como tiempo desde el inicio de la inducción hasta la extubación del paciente.
    -Valoración de la escala de Lund-Mackay previa a la cirugía
    -Complicaciones postoperatorias, quirúrgicas y anestésicas
    -Duración del ingreso hospitalario
    -Evaluación en la visita de seguimiento ambulatoria al cabo de aproximadamente 1 semana del sangrado y/o complicaciones tardías postoperatorios.
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the surgery
    Durante la intervención
    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) Yes
    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 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) 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 patient last visit
    Última visita del último paciente incluido
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 94
    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 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 state94
    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)
    standard of care
    tratamiento habitual
    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 Decision2015-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-21
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 03 17:35:56 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA