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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   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:2011-005965-18
    Sponsor's Protocol Code Number:ORL-CENS-2012
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-19
    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 number2011-005965-18
    A.3Full title of the trial
    Open randomized trial to compare the bleeding during endoscopic nasal surgery after hypotensive anesthesia with clonidine or remifentanil.
    Ensayo clínico aleatorizado abierto para comparar el sangrado durante la cirugía endoscópica nasal tras anestesia hipotensiva con clonidina o remifentanilo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open randomized trial to compare the bleeding during endoscopic nasal surgery after hypotensive anesthesia with clonidine or remifentanil.
    Ensayo clínico aleatorizado abierto para comparar el sangrado durante la cirugía endoscópica nasal tras anestesia hipotensiva con clonidina o remifentanilo.
    A.4.1Sponsor's protocol code numberORL-CENS-2012
    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 number34937236673
    B.5.5Fax number34937175067
    B.5.6E-mailfpt@tauli.cat
    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.2.5The 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.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive nameNot applicable
    D.3.9.4EV Substance CodeSUB06730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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.2.5The 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 nameremifentanil
    D.3.4Pharmaceutical form Powder for 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.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive nameNot applicable
    D.3.9.4EV Substance CodeSUB10272MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.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 14.1
    E.1.2Level PT
    E.1.2Classification code 10028756
    E.1.2Term Nasal polyps
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10052967
    E.1.2Term Nasopharyngeal surgery
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10040749
    E.1.2Term Sinus polyp
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    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 between two anesthetic schemes routinely used in clinical practice: one based on opioid derivatives and one that includes preoperative administration of clonidine, as assessed through a modified Boezaart score for surgical field bleeding.
    Comparar el sangrado intraoperatorio durante la cirugía endoscópica nasosinusal entre dos pautas anestésicas empleadas en la práctica clínica habitual: una basada en derivados opioides, y una que incluye la administración preoperatoria de clonidina mediante la estimación realizada con la escala de Boezaart del sangrado del campo quirúrgico modificada.
    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
    - Validation of assessments of the surgical field through the unmodified and modified Boezaart score and with the Wormald scale.
    - 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
    - Validar la evaluación del estado del campo quirúrgico evaluado según la clasificación entre la escala Boezaart completa y reclasificada en sangrado escaso y copioso con la obtenida con la escala de Wormald.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients of age >18 and < 65 who will undergo nasosinusal endoscopic surgery because of chronic infectious sinusitis and/or nasal polyposis
    Patients with ASA criteria I, II o III.
    Women with child-bearing potential should have a negative result in a pregnancy test either in blood or urine in the selection visit, and should agree to use appropriate contraceptive methods during at least 14 days before the first treatment dose and until at least 14 days after last treatment dose.
    Patients providing their informed consent
    Criterios de inclusión:
    Pacientes mayores de 18 años y menores de 65 años que vayan a ser sometidos a CENS por patología sinusal crónica; primaria o secundaria, ya sea por poliposis nasal o por sinusopatía crónica infecciosa.
    Pacientes con criterios ASA I, II o III.
    Las mujeres en edad fértil deberán obtener un resultado negativo en una prueba de embarazo en suero o en orina en la visita de selección, y aceptar el empleo de métodos anticonceptivos adecuados al menos desde los 14 días previos a la administración de la primera dosis del fármaco de estudio y hasta los 14 días siguientes a la última dosis administrada.
    Pacientes que otorguen su consentimiento informado.
    E.4Principal exclusion criteria
    Patients who have contraindications to the intended nasosinusal endoscopic surgery or to the anaesthesic treatment used in the routine clinical practice of this type of surgery.
    Pregnant women, women who are breast-feeding.
    Patients with impaired coagulation or who are treated with antiaggregants or anticoagulants.
    Patients with antecedents of coronary arteriopathy or heart rhytm diseases (tachyarhythmias or blockages).
    Patients that at the time of surgery show signs of hypovolemia, severe hypotension or signs of heart failure.
    Previous cerebro-vascular event.
    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.
    Patients for whom their caring physician considers that participation in the study may be clinically detrimental.
    Pacientes con contraindicaciones para someterse a la intervención quirúrgica CENS o al tratamiento anestésico utilizado en la práctica clínica habitual para la cirugía CENS
    Mujeres embarazadas o en periodo de lactancia
    Pacientes con trastornos de la coagulación, o que reciban tratamiento con medicamentos antiagregantes o anticoagulantes.
    Pacientes con historia previa de arteriopatía coronaria o trastornos del ritmo (taquiarrítmias cardiacas o bloqueos).
    Pacientes que en el momento de la intervención presenten signos de hipovolemia, hipotensión severa, o signos de fallo cardíaco.
    Antecedente de accidente vascular cerebral
    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).
    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)
    Surgical field bleeding as assessed by a modified Boezaart scale every 60 minutes; the average score for the assessments at different time points will be calculated and this will be recoded for the main study assessment to a dichotomic variable, where mild bleeding will be scores lower or equal to 2 and intense bleeding will be those scores higher than 2.
    Variable principal: Sangrado del campo quiru?rgico evaluado mediante la escala de Boezaart cada 60 minutos
    ? Grado 1: Condiciones cadave?ricas que requieren de mi?nima succio?n.
    ? Grado 2: Sangrado mi?nimo que requiere de succio?n infrecuente.
    ? Grado 3: Sangrado activo que requiere de succio?n frecuente.
    ? Grado 4: El sangrado cubre el campo quiru?rgico despue?s de retirar la succio?n y antes de que el instrumento pueda ser maniobrado.
    ? Grado 5: Sangrado no controlado. Sangrado por fuera de la narina al retirar la succio?n.
    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
    Cada 60 minutos durante la intervención; 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.5.2Secondary end point(s)
    Intraoperative bleeding in mL where blood loss is measured as Hb (g dl-1) x V (ml) / Hbm (g dl-1)
    Bleeding assessment as measured by the surgeon and a third assessor who will be blind to treatment assignation, through visualization of video recorded surgery, through different scales assessed every 60 minutes:
    Visual analogue scale (VAS) of bleeding intensity
    Boezaart scale
    Wormald scale
    Duration of the procedure, assessed as time from surgeon starting the procedure until the nasal tampooning.
    Duration of anaesthesia, defined as the time lapsed between induction until extubation.
    Postoperative, intraoperative and anaesthetic complications
    Duration of the hospital stay
    Assessment at a follow-up outpatient visit one week after surgery: bleeding and late somplications of surgery
    Proportion of patients with AE
    Proportion of patients with AE with suspected relationship to stuyd medication
    Variables secundarias:
    ? Estimación del sangrado intraoperatorio estimado en mililitros, donde la pérdida de sangre en ml se calcula como Hba (g dl-1) x V (ml) / Hbm (g dl-1)
    ? 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:
    ? Escala analógica visual (EVA) de intensidad del sangrado del campo operatorio
    ? Escala de Boezaart
    ? Escala de Wormald
    ? 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.
    ? Complicaciones postoperatorias, Q y anestesia
    ? Duración del ingreso hospitalario
    ? Evaluación en la visita de seguimiento ambulatoria al cabo de aproximadamente 1 semana del sangrado y/o complicaciones tardías postoperatorias.
    ? Proporción de pacientes con AAs posteriores al tratamiento en cada grupo de asignación
    ? Proporción de pacientes con AAs con sospecha de relación con la medicación del estudio en cada grupo de tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 60 minutes during the surgical procedure.
    Follow-up one week after surgery.
    Cada 60 minutos durante la intervención quirúrgica.
    Seguimiento tras el alta al cabo de 1 semana.
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 last patient
    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 months3
    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 months3
    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: 46
    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 state46
    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 Decision2012-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-07
    P. End of Trial
    P.End of Trial StatusCompleted
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