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    Summary
    EudraCT Number:2021-000727-12
    Sponsor's Protocol Code Number:RC31/20/0443
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-11
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-000727-12
    A.3Full title of the trial
    Quality Assessment of Tracheal intubation without neuromuscular blocking drugs (Propofol+ Remifentanil) in obese patients: Pilot Study

    Évaluation de la qualité d’intubation sans curare (propofol et rémifentanil) chez le patient obèse : étude pilote
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Quality Assessment of Tracheal intubation without neuromuscular blocking drugs (Propofol+ Remifentanil) in obese patients: Pilot Study
    Évaluation de la qualité d’intubation sans curare (propofol et rémifentanil) chez le patient obèse : étude pilote
    A.3.2Name or abbreviated title of the trial where available
    OBEREM
    OBEREM
    A.4.1Sponsor's protocol code numberRC31/20/0443
    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 SponsorUniversity Hospital of Toulouse
    B.1.3.4CountryFrance
    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 supportUniversity Hospital of Toulouse
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Toulouse
    B.5.2Functional name of contact pointDRI
    B.5.3 Address:
    B.5.3.1Street Address2 rue VIGUERIE
    B.5.3.2Town/ cityTOULOUSE
    B.5.3.3Post code31059
    B.5.3.4CountryFrance
    B.5.4Telephone number330561777132
    B.5.5Fax number330561778411
    B.5.6E-mailbelloc.a@chu-toulouse.fr
    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 rémifentanil 2mg ; poudre pour solution injectable ou pour perfusion
    D.2.1.1.2Name of the Marketing Authorisation holderMylan
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namerémifentanil
    D.3.4Pharmaceutical form Powder for concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    induction phase of the general anesthesia in obese patients
    Phase d'induction de l'anesthésie générale chez le patient obèse
    E.1.1.1Medical condition in easily understood language
    induction phase of the general anesthesia in obese patients
    Phase d'induction de l'anesthésie générale chez le patient obèse
    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
    To evaluate in obese subjects the quality of intubation with two dosages, after induction without curare (propofol and remifentanil) in order to have a reliable estimate of the percentage of patients with excellent intubation conditions
    Evaluer chez le sujet obèse la qualité d’intubation avec deux posologies, après induction sans curare (propofol et rémifentanil) afin d’avoir une estimation fiable du pourcentage de patient ayant d’excellentes conditions d’intubation
    E.2.2Secondary objectives of the trial
    To evaluate in both groups the difficulty of intubation, the respiratory impact of induction, the hemodynamic impact, and the occurrence of traumatic complications related to intubation.
    Evaluer dans les deux groupes la difficulté d’intubation, le retentissement respiratoire de l’induction, le retentissement hémodynamique, et la survenue de complications traumatiques liées à l’intubation..
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient 18-60 years of age.
    - ASA class ≤ 3
    - Patient with a BMI between 35 and 60 with indication for bariatric surgery, or BMI greater than 30 in case of bariatric surgery revision.
    - Patient scheduled for bariatric surgery (or repeat bariatric surgery) scheduled under general anesthesia with orotracheal intubation.
    - Patient de 18 à 60 ans.
    - Classe ASA ≤ 3
    - Patient ayant un BMI compris entre 35 et 60 avec indication de chirurgie bariatrique, ou BMI supérieur à 30 dans le cas de reprise de chirurgie bariatrique.
    - Patient prévu pour une chirurgie bariatrique (ou reprise de chirurgie bariatrique) programmée sous anesthésie générale avec intubation orotrachéale.
    E.4Principal exclusion criteria
    "Full stomach" patient defined by at least 1 of the following criteria:
    o Esophageal fibroscopy with visualized hiatal hernia.
    o Authenticated and treated gastroesophageal reflux.
    o Previously placed gastric band.
    - Known difficult orotracheal intubation (Cormack score ≥ 3 (see Appendix 5)31).
    - Opioid or substituted drug addiction (Methadone, Buprenorphine...).
    - Chronic alcoholism (suspected or admitted).
    - Chronic treatment with an opiate.
    - Patient under guardianship, curatorship or under court protection.
    - Known hypersensitivity to propofol, sufentanil, remifentanil, soy or peanuts.
    - Severe renal or hepatic impairment.
    - Severe respiratory insufficiency.
    - Pregnant or breastfeeding woman.
    - Patient participating in another interventional research protocol that may interfere with study drugs
    - Patient « estomac plein » défini par au moins 1 critère parmi :
    o Fibroscopie oeso-gastrique avec hernie hiatale visualisée.
    o Reflux gastro-œsophagien authentifié et traité.
    o Anneau gastrique déjà posé.
    - Intubation orotrachéale difficile connue (score de Cormack ≥ 3 (cf. annexe 5)31).
    - Toxicomanie à un opiacé ou substituée (Méthadone, Buprénorphine…)
    - Alcoolisme chronique (suspecté ou avoué).
    - Traitement chronique par un opiacé.
    - Patient sous tutelle, curatelle ou en sauvegarde de justice.
    - Hypersensibilité connue au propofol, au sufentanil, au rémifentanil, au soja ou aux arachides.
    - Insuffisance rénale ou hépatique sévère.
    - Insuffisance respiratoire sévère.
    - Femme enceinte ou allaitante.
    - Patient participant à un autre protocole de recherche interventionnelle pouvant interférer avec les médicaments de l’étude.
    E.5 End points
    E.5.1Primary end point(s)
    percentage of patients with excellent orotracheal intubation conditions
    pourcentage de patients présentant des conditions excellentes d’intubation orotrachéale
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0 Hour 0
    Jour 0 Heure 0
    E.5.2Secondary end point(s)
    - Difficulty of orotracheal intubation
    o Intubation Difficulty Scale (IDS) score (Appendix 2) for complexity of endotracheal intubation28
    o Percentage of patients who required re-ventilation after a failed first attempt at intubation
    o Percentage of patients who received an additional dose of propofol at induction
    o Percentage using the emergency protocol established by the study.

    - Respiratory impact of induction
    o Percentage of patients with desaturation, defined as pulse oxygen saturation below 90%.
    o Percentage of patients with suspected inhalation, defined as visualization of gastric fluid in the oropharynx on intubation or inhalation pneumonitis diagnosed within 48 hours of surgery.

    - Hemodynamic impact of induction
    o Percentage of patients with a drop of more than 20% in mean arterial pressure (MAP) within 40 minutes of induction.
    o Percentage of patients with a decrease of more than 20% in Heart Rate (HR) within 40 minutes of induction.
    o Number of uses of vasopressor drugs, with details of the drug administered (ephedrine, phenylephrine, norepinephrine, adrenaline, atropine).

    - Traumatic complications related to intubation
    o Percentage of patients with traumatic complications associated with intubation: dental breaks, lip and/or mouth sores, oropharyngeal bleeding, vocal cord trauma
    o Percentage of patients with laryngeal pain, aphonia, dysphonia postoperatively.
    - Difficulté d’intubation orotrachéale
    o Score « Intubation Difficulty Scale » (IDS) ; (Annexe 2) de complexité de l’intubation endotrachéale28.
    o Pourcentage de patient ayant nécessité une re-ventilation avec échec d’une première tentative d’intubation.
    o Pourcentage de patient ayant bénéficié d’une dose complémentaire de propofol à l’induction.
    o Pourcentage de recours au protocole d’urgence établie par l’étude.

    - Retentissement respiratoire de l’induction
    o Pourcentage de patient présentant une désaturation, définie par une saturation pulsée en oxygène inférieure à 90%.
    o Pourcentage de patient présentant une suspicion d’inhalation, définie par la visualisation à l’intubation de liquide gastrique dans l’oropharynx ou une pneumopathie d’inhalation diagnostiquée dans les 48h post-opératoire.

    - Retentissement hémodynamique de l’induction
    o Pourcentage de patients présentant une baisse de plus de 20% de Pression Artérielle Moyenne (PAM) dans les 40 minutes suivant l’induction.
    o Pourcentage de patients présentant une baisse de plus de 20% de Fréquence Cardiaque (FC) dans les 40 minutes suivant l’induction.
    o Nombre de recours aux médicaments vasopresseurs, avec détail du médicament administré (éphedrine, phényléphrine, noradrénaline, adrénaline, atropine).

    - Complications traumatiques liées à l’intubation
    o Pourcentage de patients avec des complications traumatiques associées à l’intubation : bris dentaires, plaie de lèvre et/ou de bouche, saignement oropharyngé, traumatisme des cordes vocales.
    o Pourcentage de patient présentant des douleurs laryngées, une aphonie, une dysphonie en post-opératoire.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Hour H2 and Hour H48 post anesthesic induction without curare (propofol and remifentanil)
    Heure H2 and heure H48 après induction anesthésique sans curare (propofol etremifentanil)
    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 Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    même médicament (rémifentanil) mais avec un dosage différent
    same treatment (remifentanil) but with other dosis
    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
    DVDP
    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 months19
    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: 60
    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 state60
    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)
    Identical than expected normal treatment of that condition
    Identique au traitement normal attendu
    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 Decision2021-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-23
    P. End of Trial
    P.End of Trial StatusCompleted
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