دورية أكاديمية
Efficacy of naloxone in reducing postictal central respiratory dysfunction in patients with epilepsy: study protocol for a double- blind, randomized, placebo-controlled trial
| العنوان: | Efficacy of naloxone in reducing postictal central respiratory dysfunction in patients with epilepsy: study protocol for a double- blind, randomized, placebo-controlled trial |
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| المؤلفون: | Rheims, Sylvain, Valton, Luc, Michel, Véronique, Maillard, Louis, Navarro, Vincent, Convers, Philippe, Bartolomei, Fabrice, Biraben, Arnaud, Crespel, Arielle, Derambure, Philippe, de Toffol, Bertrand, Hirsch, Edouard, Kahane, Philippe, Lemesle Martin, Martine, Tourniaire, Didier, Boulogne, Sébastien, Mercier, Catherine, Roy, Pascal, Ryvlin, Philippe |
| المساهمون: | Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center (CRNL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Institut Des Épilepsies de l'Enfant et de l'adolescent (CTRS-IDEE), Hospices Civils de Lyon (HCL), Service de neurologie fonctionnelle et d'épileptologie Hôpital Pierre Wertheimer-HCL, Hôpital neurologique et neurochirurgical Pierre Wertheimer CHU - HCL, Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Pôle Neurosciences CHU Toulouse, Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Neurophysiologie clinique CHU Bordeaux, CHU Bordeaux Bordeaux, Service de neurologie CHRU Nancy, Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Centre de Recherche en Automatique de Nancy (CRAN), Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), CHU Pitié-Salpêtrière AP-HP, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut du Cerveau et de la Moëlle Epinière = Brain and Spine Institute (ICM), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière AP-HP, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Service de Neurologie CHU de Saint-Étienne, Centre Hospitalier Universitaire de Saint-Etienne CHU Saint-Etienne (CHU ST-E)-Université Jean Monnet - Saint-Étienne (UJM), Institut de Neurosciences de la Timone (INT), Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Service de neurologie Rennes, Université de Rennes (UR), Unité d'épilepsie CHU Montpellier, Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier), Département de neurologie Lille, Centre Hospitalier Régional Universitaire Lille (CHRU Lille), Service de Neurologie Tours, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau, Service de Neurologie Strasbourg, CHU Strasbourg-Hopital Civil, GIN Grenoble Institut des Neurosciences (GIN), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes 2016-2019 (UGA 2016-2019 ), Service de Neurologie : Unité Troubles du mouvement Hôpital Michallon, Grenoble, Hôpital Michallon, Service de neurochirurgie CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Centre d'épilepsie La Teppe, Service de Biostatistique des Hospices Civils de Lyon, Service de Biostatistiques Lyon, Centre Hospitalier Universitaire Vaudois Lausanne (CHUV) |
| المصدر: | ISSN: 1745-6215 ; Trials ; https://hal.sorbonne-universite.fr/hal-01404985Test ; Trials, 2016, 17, pp.529. ⟨10.1186/s13063-016-1653-1⟩. |
| بيانات النشر: | HAL CCSD BioMed Central |
| سنة النشر: | 2016 |
| المجموعة: | Archive Ouverte de l'Université Rennes (HAL) |
| مصطلحات موضوعية: | SUDEP, Naloxone, Epilepsy, Opioids, [SDV.NEU.NB]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology, [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication |
| الوصف: | on behalf of ENALEPSY study group ; International audience ; Background: Generalized tonic-clonic seizures (GTCSs) are the main risk factor for sudden unexpected death in epilepsy (SUDEP). Experimental and clinical data strongly suggest that the majority of SUDEP results from a postictal respiratory dysfunction progressing to terminal apnea. Postictal apnea could partly derive from a seizure-induced massive release of endogenous opioids. The main objective of this study is to evaluate the efficacy of an opioid antagonist, naloxone, administered in the immediate aftermath of a GTCS, in reducing the severity of the postictal central respiratory dysfunction.Methods/design: The Efficacy of Naloxone in Reducing Postictal Central Respiratory Dysfunction in Patients with Epilepsy (ENALEPSY) study is a multicenter, double-blind, randomized, placebo-controlled trial conducted in patients with drug-resistant focal epilepsy who are undergoing long-term video-electroencephalogram (EEG) monitoring (LTM) in an epilepsy monitoring unit (EMU). We plan to randomize 166 patients (1:1) to receive intravenous naloxone (0.4 mg) or placebo in the immediate aftermath of a GTCS. Because inclusion in the study needs to take place prior to the occurrence of the GTCS, and because such occurrence is observed in about one-fourth of patients undergoing LTM, we plan to include a maximum of 700 patients upon admission in the EMU. The primary endpoint will be the proportion of patients whose oxygen saturation is <90 % between 1 and 3 min after the end of a GTCS. Secondary outcomes will include the following: the proportion of patients who show postictal apnea, the occurrence and duration of postictal generalized EEG suppression, the total duration of the postictal coma, postictal pain, and the number of patients who have a second GTCS within 120 min after the intravenous injection.Discussion: The demonstration of naloxone’s efficacy on the severity of postictal hypoxemia will have two primary consequences. First, naloxone would be the first ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/27809868; hal-01404985; https://hal.sorbonne-universite.fr/hal-01404985Test; https://hal.sorbonne-universite.fr/hal-01404985/documentTest; https://hal.sorbonne-universite.fr/hal-01404985/file/efficacy.pdfTest; PUBMED: 27809868 |
| DOI: | 10.1186/s13063-016-1653-1 |
| الإتاحة: | https://doi.org/10.1186/s13063-016-1653-1Test https://hal.sorbonne-universite.fr/hal-01404985Test https://hal.sorbonne-universite.fr/hal-01404985/documentTest https://hal.sorbonne-universite.fr/hal-01404985/file/efficacy.pdfTest |
| حقوق: | http://creativecommons.org/licenses/byTest/ ; info:eu-repo/semantics/OpenAccess |
| رقم الانضمام: | edsbas.32F34A0A |
| قاعدة البيانات: | BASE |
| DOI: | 10.1186/s13063-016-1653-1 |
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