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    Summary
    EudraCT Number:2016-002197-13
    Sponsor's Protocol Code Number:ANE_SEVPRO_2016_01
    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:2016-10-26
    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 number2016-002197-13
    A.3Full title of the trial
    IMPLICATION OF TWO ANESTHETIC TECHNIQUES: SEVOFLURANE VERSUS PROPOFOL TO REDUCE BLOOD LOSS IN ORTHOGNATHIC SURGERY
    IMPLICACIÓN DE DOS TÉCNICAS ANESTÉSICAS: SEVOFLURANE VERSUS PROPOFOL PARA REDUCIR LA PÉRDIDA SANGUÍNEA EN CIRUGÍA ORTOGNÁTICA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    IMPLICATION OF TWO ANESTHETIC TECHNIQUES TO REDUCE BLOOD LOSS IN CORRECTIVE JAW SURGERY.
    IMPLICACIÓN DE DOS TÉCNICAS ANESTÉSICAS PARA REDUCIR EL SANGRADO EN LA CIRUGÍA CORRECTIVA DE LA MANDÍBULA.
    A.4.1Sponsor's protocol code numberANE_SEVPRO_2016_01
    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 SponsorServicio de Anestesiología y Reanimación
    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 supportHOSPITAL UNIVERSITARIO LA PAZ
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationServicio de Anestesiología y Reanimación
    B.5.2Functional name of contact pointBLANCA
    B.5.3 Address:
    B.5.3.1Street AddressPASEO DE LA CASTELLANA 261
    B.5.3.2Town/ cityMADRID
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number34912077558
    B.5.5Fax number34912071466
    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
    D.2.1.1.2Name of the Marketing Authorisation holderABBVIE
    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 nameSEVORANE
    D.3.2Product code 61.451
    D.3.4Pharmaceutical form Inhalation vapour, liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSevoflurane
    D.3.9.1CAS number 28523-86-6
    D.3.9.3Other descriptive nameSEVOFLURANE
    D.3.9.4EV Substance CodeSUB10506MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4 to 6
    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.2.1.1.2Name of the Marketing Authorisation holderPropofol Lipomed Fresenius
    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 namePROPOFOL
    D.3.2Product code PROPOFOL
    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.3.8 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/kg/h milligram(s)/kilogram/hour
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number3 to 8
    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
    Assessment of the bleeding in ortognatic surgery.
    Evaluación del sangrado en cirugía ortognática.
    E.1.1.1Medical condition in easily understood language
    Assessment of the bleeding in corrective jaw surgery.
    Evaluación del sangrado en la cirugía correctiva de la mandíbula.
    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
    Quantification of blood loss in orthognathic surgery comparing Propofol against Sevoflurane.
    Cuantificación de pérdida sanguínea en cirugía ortognática comparando Sevofluorane frente a Propofol.
    E.2.2Secondary objectives of the trial
    To compare the incidence of adverse events, especially the appearance of postoperative nausea and vomiting between the two drugs.

    Evaluation of postoperative facial edema.

    Assess the immediate and late postoperative pain.

    Evaluation of bleeding in surgical field according to the scale of Fromme.

    Assessing the degree of patient satisfaction.
    Comparar la incidencia de acontecimientos adversos, en especial la aparición de náuseas y vómitos postoperatorios entre ambos fármacos.

    Evaluación del edema facial postoperatorio.

    Evaluar el dolor postoperatorio inmediato y tardío.

    Evaluación del sangrado en campo quirúrgico según la escala de Fromme.

    Evaluación del grado de satisfacción del paciente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients ≥ 18 and ≤ 65 years old.

    • Classification ASA (American Society of Anesthesiologists) I or II.

    • orthognathic surgery scheduled bimaxillary

    • Signed informed consent
    • Pacientes ≥ 18 y ≤ 65 años.

    • Clasificación según la sociedad americana de anestesia (ASA) I o II.

    • Cirugía ortognática bimaxilar programada

    • Firma del consentimiento informado
    E.4Principal exclusion criteria
    • Patients who do not wish to consent to participate in the study.
    • Hemodynamic instability determined by the need for continuous infusion of inotropic or vasopressor.
    • Severe heart disease (Grades III and IV, NYHA)
    • Kidney disease (creatinine clearance ≤ 30 mL / min)
    • Liver disease (Grade C Child-Pugh).
    • Diabetes Mellitus Type I or II compensated or decompensated.
    • Previous surgery in the surgical field including orthognathic surgery.
    • Patients with treatments or diseases affecting the coagulation cascade or platelet aggregation.
    • Pacientes que no deseen dar su consentimiento para participar en el estudio.
    • Inestabilidad hemodinámica determinada por la necesidad de infusión continúa de inotrópicos o vasopresores.
    • Enfermedad cardiaca severa (Grados III y IV) de la NYHA
    • Enfermedad renal ((Aclaramiento de creatinina ≤ 30 mL/min)
    • Enfermedad hepática (Grado C de Child-Pugh).
    • Diabetes Mellitus tipo I o II compensados o descompensados
    • Cirugía previa en el campo quirúrgico que incluye la cirugía ortognática.
    • Pacientes con tratamientos o enfermedades que afecten a la cascada de coagulación o a la agregación plaquetaria.
    E.5 End points
    E.5.1Primary end point(s)
    Total intra-operative bleeding or surgical difficulty (subjective)
    Sangrado total intraoperatorio o dificultad quirúrgica (subjetivo)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of surgery.
    Al final de la cirugía.
    E.5.2Secondary end point(s)
    Demographic variables:
    •Age
    • Sex
    •Weight
    •Height
    • Body Mass Index

    Time variables:
    • Duration of surgery
    • Duration of anesthesia

    Anesthetic variables:
    • Mean arterial pressure (MAP)
    • Systolic blood pressure (SBP)
    • diastolic blood pressure (DBP)
    • Total dose administered per kg weight of intraoperative remifentanil and opioids.
    Variables demográficas:
    • Edad
    • Sexo
    • Peso
    • Altura
    • Índice de masa corporal

    Variables de tiempo:
    • Duración de la cirugía
    • Duración de la anestesia

    Variables anestésicas:
    • Presión arterial media (PAM)
    • Presión Arterial Sistólica (PAS)
    • Presión Arterial Diastólica (PAD)
    • Dosis total administrada por kg peso de Remifentanilo y opioides intraoperatorios.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the start of the study: Demographic variables.

    At the end of surgery: Time and anesthetic variables.
    Al principio del estudio: Variables demográficas.

    Al final de la cirugía: Variables de tiempo y anestésicas.
    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 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 Yes
    E.8.2.3.1Comparator description
    Propofol
    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
    LVLS
    Última visita del último sujeto.
    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 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: 100
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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
    NINGUNO
    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 Decision2017-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-09
    P. End of Trial
    P.End of Trial StatusOngoing
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