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    The EU Clinical Trials Register currently displays   44157   clinical trials with a EudraCT protocol, of which   7327   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:2022-001027-33
    Sponsor's Protocol Code Number:PAFIBAR1.0
    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:2023-03-24
    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 number2022-001027-33
    A.3Full title of the trial
    Evaluation of the effect of Opioid-Free Anesthesia on oxygenation in bariatric surgery
    Evaluación del efecto de la Anestesia Libre de Opioides sobre la oxigenación en cirugía bariátrica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the effect of Opioid-Free Anesthesia
    Evaluación del efecto de la Anestesia Libre de Opioides
    A.3.2Name or abbreviated title of the trial where available
    PAFIBAR 1.0
    A.4.1Sponsor's protocol code numberPAFIBAR1.0
    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 SponsorFIMABIS
    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 supportOwn Department
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFIMABIS
    B.5.2Functional name of contact pointClinical Trials Unit
    B.5.3 Address:
    B.5.3.1Street Address7º Planta Pab A. Hospital Regional Universitario. Avda Carlos Haya s/n
    B.5.3.2Town/ cityMálaga
    B.5.3.3Post code29010
    B.5.3.4CountrySpain
    B.5.4Telephone number34951291977
    B.5.5Fax number34951440263
    B.5.6E-mailgloria.luque@ibima.eu
    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 DEXMETODIMINA
    D.2.1.1.2Name of the Marketing Authorisation holderALTAN PHARMA
    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 nameDEXMETODIMINA
    D.3.2Product code 113775-47-6
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfusion (Noncurrent)
    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 µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.4 to 1.4
    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.2.1.1.1Trade name PROPOFOL
    D.2.1.1.2Name of the Marketing Authorisation holderFRESENIUS
    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.3.4Pharmaceutical form Emulsion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfusion (Noncurrent)
    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.3.9.4EV Substance CodeSUB10116MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.5 to 2.5
    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.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
    Bariatric surgery
    Cirugía bariátrica
    E.1.1.1Medical condition in easily understood language
    Obesity surgery
    Cirugía de la obesidad
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10068900
    E.1.2Term Bariatric surgery
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of Opioid-Free Anesthesia on the ratio arterial oxygen pressure/Fraction of inspired oxygen (PaO2/FiO2) during the first 6 postoperative hours compared to conventional anesthesia.
    Evaluar el efecto de la Anestesia Libre de Opioides en el cociente Presión arterial de oxígeno/Fracción inspirada de oxígeno (PaO2/FiO2) durante las primeras 6 horas postoperatorias en comparación con la anestesia convencional.
    E.2.2Secondary objectives of the trial
    - Assess the effects on ventilation by measuring the partial pressure of oxygen (PCO2).
    - Evaluate hemodynamic stability, by comparing blood pressure (BP) and basal heart rate, after intubation, after surgical stimulation and upon arrival at the post-anesthesia resuscitation unit (PACU).
    - Evaluate pain control and consumption of postoperative morphic.
    - Evaluate postoperative nausea and vomiting.
    - Evaluate post-surgical recovery and length of hospital stay.
    - Assess costs
    • Evaluar los efectos sobre la ventilación mediante la medición de la presión parcial de oxígeno (PCO2).
    • Evaluar la estabilidad hemodinámica, mediante la comparación entre Tensión arterial (TA) y frecuencia cardiaca basal, tras la intubación, tras el estímulo quirúrgico y a su llegada a la unidad de reanimación postanestésica (URPA).
    • Evaluar el control del dolor y consumo de mórfico postoperatorio.
    • Evaluar las nauseas y vómitos postoperatorios.
    • Evaluar la recuperación postquirúrgica y la duración del ingreso hospitalario.
    • Evaluar los costes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients aged 18 or over.
    2. Patients pending laparoscopic sleeve gastrectomy for bariatric surgery.
    3. Informed consent.
    1. Pacientes con 18 o más años cumplidos.
    2. Pacientes pendientes de realización de gastrectomía vertical laparoscópica por cirugía bariátrica.
    3. Que otorgue el consentimiento informado.
    E.4Principal exclusion criteria
    1. Advanced heart block (grade 2 or 3 in the absence of a pacemaker).
    2. Preoperative renal dysfunction, estimated through the preoperative GFR rate (creatinine clearance < 50ml/min).
    3. Liver failure.
    4. Hypersensitivity to gabapentin, lidocaine, dexmedetomidine, ketamine, NSAIDs, paracetamol or Magnesium Sulfate.
    5. Myasthenia gravis.
    1. Bloqueo cardiaco avanzado (grado 2 o 3 en ausencia de marcapasos).
    2. Disfunción renal preoperatoria, estimada a través de la tasa de FG preoperatoria (aclaramiento de creatinina < 50ml/min).
    3. Insuficiencia hepática.
    4. Hipersensibilidad a gabapentina, lidocaína, dexmedetomidina, ketamina, AINEs, paracetamol o Sulfato de Magnesio.
    5. Miastenia gravis.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the effect of Opioid-Free Anesthesia on the ratio arterial oxygen pressure/Fraction of inspired oxygen (PaO2/FiO2) during the first 6 postoperative hours compared to conventional anesthesia.
    Evaluar el efecto de la Anestesia Libre de Opioides en el cociente Presión arterial de oxígeno/Fracción inspirada de oxígeno (PaO2/FiO2) durante las primeras 6 horas postoperatorias en comparación con la anestesia convencional.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Intrasurgery
    Post-Anesthetic Recovery Unit arrival
    1 hour after Post-Anesthetic Recovery Unit arrival
    6 hours Post-Anesthetic Recovery Unit arrival
    24 hours ince begining of the surgery
    Intraoperatoria
    Llegada a la Unidad de Recuperación Postanestésica
    1 hora tras la llegada a la Unidad de Recuperación Postanestésica
    6 horas tras la llegada a la Unidad de Recuperación Postanestésica
    24 horas tras el inicio de la cirugía
    E.5.2Secondary end point(s)
    - Assess the effects on ventilation by measuring the partial pressure of oxygen (PCO2).
    - Evaluate hemodynamic stability, by comparing blood pressure (BP) and basal heart rate, after intubation, after surgical stimulation and upon arrival at the post-anesthesia resuscitation unit (PACU).
    - Evaluate pain control and consumption of postoperative morphic.
    - Evaluate postoperative nausea and vomiting.
    - Evaluate post-surgical recovery and length of hospital stay.
    - Assess costs
    • Evaluar los efectos sobre la ventilación mediante la medición de la presión parcial de oxígeno (PCO2).
    • Evaluar la estabilidad hemodinámica, mediante la comparación entre Tensión arterial (TA) y frecuencia cardiaca basal, tras la intubación, tras el estímulo quirúrgico y a su llegada a la unidad de reanimación postanestésica (URPA).
    • Evaluar el control del dolor y consumo de mórfico postoperatorio.
    • Evaluar las nauseas y vómitos postoperatorios.
    • Evaluar la recuperación postquirúrgica y la duración del ingreso hospitalario.
    • Evaluar los costes
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Assess the effects on ventilation by measuring the partial pressure of oxygen (PCO2).
    - Evaluate hemodynamic stability, by comparing blood pressure (BP) and basal heart rate, after intubation, after surgical stimulation and upon arrival at the post-anesthesia resuscitation unit (PACU).
    - Evaluate pain control and consumption of postoperative morphic.
    - Evaluate postoperative nausea and vomiting.
    - Evaluate post-surgical recovery and length of hospital stay.
    - Assess costs
    • Evaluar los efectos sobre la ventilación mediante la medición de la presión parcial de oxígeno (PCO2).
    • Evaluar la estabilidad hemodinámica, mediante la comparación entre Tensión arterial (TA) y frecuencia cardiaca basal, tras la intubación, tras el estímulo quirúrgico y a su llegada a la unidad de reanimación postanestésica (URPA).
    • Evaluar el control del dolor y consumo de mórfico postoperatorio.
    • Evaluar las nauseas y vómitos postoperatorios.
    • Evaluar la recuperación postquirúrgica y la duración del ingreso hospitalario.
    • Evaluar los costes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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
    LVLP
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    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) No
    F.1.2.1Number of subjects for this age range: 72
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 72
    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 Yes
    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 state72
    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)
    Nono
    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 Decision2023-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-06-07
    P. End of Trial
    P.End of Trial StatusOngoing
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