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    The EU Clinical Trials Register currently displays   43977   clinical trials with a EudraCT protocol, of which   7312   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:2014-005156-26
    Sponsor's Protocol Code Number:PRIN-SUGAR-2014
    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:2015-01-26
    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 number2014-005156-26
    A.3Full title of the trial
    Effects of neuromuscular block reversal with sugammadex vs neostigmine on postoperative respiratory outcomes after major abdominal surgery. A randomized controlled trial.
    EFECTO DE LA REVERSION DEL BLOQUEO NEUROMUSCULAR CON SUGAMMADEX FRENTE A NEOSTIGMINA EN LA FUNCION PULMONAR POSTOPERATORIA. ESTUDIO ALEATORIZADO Y CONTROLADO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of neuromuscular block reversal with sugammadex vs neostigmine on postoperative respiratory outcomes after major abdominal surgery. A randomized controlled trial.
    EFECTO DE LA REVERSION DEL BLOQUEO NEUROMUSCULAR CON SUGAMMADEX FRENTE A NEOSTIGMINA EN LA FUNCION PULMONAR POSTOPERATORIA. ESTUDIO ALEATORIZADO Y CONTROLADO
    A.3.2Name or abbreviated title of the trial where available
    Sugammadex vs neostigmine on postoperative respiratory outcomes after major abdominal surgery.
    SUGAMMADEX FRENTE A NEOSTIGMINA EN LA FUNCION PULMONAR POSTOPERATORIA
    A.4.1Sponsor's protocol code numberPRIN-SUGAR-2014
    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 SponsorDr. Enrique Alday
    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 supportDr. Enrique Alday
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationServicio de Farmacología Clínica
    B.5.2Functional name of contact pointManuel Román
    B.5.3 Address:
    B.5.3.1Street AddressC/ Diego de León 62 Hospital Universitario de La Princesa
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28006
    B.5.3.4CountrySpain
    B.5.4Telephone number+34915202540
    B.5.5Fax number+34915202540
    B.5.6E-mailmanuel.roman@salud.madrid.org
    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.2.1.1.1Trade name Neostigmina Braun
    D.2.1.1.2Name of the Marketing Authorisation holderBraun Medical, S.A.
    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 nameNeostigmine
    D.3.2Product code Reference
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNEOSTIGMINE
    D.3.9.1CAS number 588-17-0
    D.3.9.2Current sponsor codeReference
    D.3.9.3Other descriptive nameR
    D.3.9.4EV Substance CodeSUB03411MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 Bridion
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp And Dohme Ltd
    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 nameSugammadex
    D.3.2Product code Test
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBridion
    D.3.9.2Current sponsor codeTest
    D.3.9.3Other descriptive nameSUGAMMADEX
    D.3.9.4EV Substance CodeSUB26695
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Patients of both sexes proposed for major abdominal surgery under general anesthesia plus epidural
    Pacientes de ambos sexos propuestos para cirugía mayor abdominal bajo anestesia general más epidural
    E.1.1.1Medical condition in easily understood language
    Patients of both sexes proposed for major abdominal surgery under general anesthesia plus epidural
    Pacientes de ambos sexos propuestos para cirugía mayor abdominal bajo anestesia general más epidural
    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
    Assess differences in the decline in forced vital capacity (FVC) among patients receiving sugammadex or neostigmine to reverse neuromuscular blockade.
    Evaluar las diferencias en el descenso en la capacidad vital forzada (CVF) entre los pacientes que reciben sugammadex o neostigmina para revertir el bloqueo neuromuscular.
    E.2.2Secondary objectives of the trial
    Differences in the size of atelectasis measured by planimetry.
    Differences in pO2 / FiO2 ratio in the first hour after surgery.
    Explore the accuracy of ultrasound to detect pulmonary atelectasis and its correlation with pO2 / FiO2, chest radiography and spirometry parameters
    Diferencias en el tamaño de las atelectasias medidas por planimetría.
    Diferencias en la relación pO2/FiO2 en la primera hora tras la intervención.
    Explorar la precisión de la ecografía pulmonar para detectar atelectasias y su correlación con la pO2/FiO2, la radiografía de tórax y los parámetros espirométricos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who previously signed informed consent.
    Patients undergoing one of the following interventions:
    -Segmental hepatectomy, atypical or lobar.
    -Whipple pancreaticoduodenectomy cephalic and type reconstruction.
    -Pancreatic resection without reconstruction
    -Splenectomy.
    -Partial or total gastrectomy
    Partial or total colectomy with or without reconstruction transit
    Pacientes que firmen previamente el consentimiento informado.
    Pacientes sometidos a alguna de las siguientes intervenciones:
    -Hepatectomía segmentaria, atípica o lobar.
    -Duodenopancreatectomía cefálica y reconstrucción tipo Whipple.
    -Resecciones de páncreas sin reconstrucción
    -Esplenectomía.
    -Gastrectomía parcial o total
    -Colectomía total o parcial con o sin reconstrucción de tránsito
    E.4Principal exclusion criteria
    ? Do not give your consent.
    ? Come to the recovery unit mechanical ventilation.
    ? Have hypersensitivity reactions to any of the study drugs.
    ? A history of severe asthma or moderate asthma treated.
    ? Have a history of pulmonary fibrosis or very severe COPD (grade IV ranking GOLD).
    ? Have had myocardial infarction or coronary occlusion the three months prior to surgery.
    ? Have Myasthenia Gravis.
    ? Please specify emergency surgery.
    ? neuromuscular blockade was performed with non-steroidal blockers do not require pharmacological reversal of blockade.
    ? Do not have an epidural catheter for postoperative pain control.
    ?No den su consentimiento.
    ?Lleguen a la unidad de reanimación bajo ventilación mecánica.
    ?Tengan reacciones de hipersensibilidad a alguna de la drogas del estudio.
    ?Tengan antecedentes de asma severo o asma moderado bajo tratamiento.
    ?Tengan antecedentes de Fibrosis pulmonar o EPOC muy severo (grado IV en la clasificación de GOLD).
    ?Hayan tenido infarto de miocardio u oclusión coronaria los tres meses previos a la cirugía.
    ?Tengan Miastenia Gravis.
    ?Precisen intervención quirúrgica urgente.
    ?Se realice el bloqueo neuromuscular con bloqueantes no esteroideos o no precisen la reversión farmacológica del bloqueo.
    ?No tengan un catéter epidural para el control del dolor postoperatorio.
    E.5 End points
    E.5.1Primary end point(s)
    The analysis of the primary endpoint were performed with the difference between CVFb (basal) and CFV1h (the first time) and the difference between CVFb and CVF24h. (forced vital capacity at 24h).
    El análisis de la variable principal se realizará con la diferencia entre la CVFb (basal) y la CFV1h (la primera hora) y sobre la diferencia entre la CVFb y la CVF24h. (capacidad vital forzada a las 24h).
    E.5.1.1Timepoint(s) of evaluation of this end point
    difference between CVFb (basal) and CFV1h (the first time) and the difference between CVFb and CVF24h. (forced vital capacity at 24h).
    la diferencia entre la CVFb (basal) y la CFV1h (la primera hora) y sobre la diferencia entre la CVFb y la CVF24h. (capacidad vital forzada a las 24h).
    E.5.2Secondary end point(s)
    Differences in the size of atelectasis measured by planimetry.
    Differences in the relationship pO2 / FiO2 in the first hour after surgery.
    Explore the accuracy of ultrasound to detect pulmonary atelectasis and its correlation with pO2 / FiO2, chest radiography and spirometry parameters
    Diferencias en el tamaño de las atelectasias medidas por planimetría.
    Diferencias en la relación pO2/FiO2 en la primera hora tras la intervención.
    Explorar la precisión de la ecografía pulmonar para detectar atelectasias y su correlación con la pO2/FiO2, la radiografía de tórax y los parámetros espirométricos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Differences in the size of atelectasis measured by planimetry.
    Differences in the relationship pO2 / FiO2 in the first hour after surgery.
    Explore the accuracy of ultrasound to detect pulmonary atelectasis and its correlation with pO2 / FiO2, chest radiography and spirometry parameters
    Diferencias en el tamaño de las atelectasias medidas por planimetría.
    Diferencias en la relación pO2/FiO2 en la primera hora tras la intervención.
    Explorar la precisión de la ecografía pulmonar para detectar atelectasias y su correlación con la pO2/FiO2, la radiografía de tórax y los parámetros espirométricos.
    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 Yes
    E.8.1.7.1Other trial design description
    Ciego para terceros
    blind for third person
    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
    Date on which the last subject completed last study visit (day of discharge).
    Fecha en la que el último sujeto completa última visita del estudio (día del alta hospitalaria).
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    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 state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    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)
    Not Apply
    No aplica
    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 Decision2015-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-27
    P. End of Trial
    P.End of Trial StatusCompleted
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