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- Essai clinique NCT01509651
Sugammadex and Heart Failure
Reversal of Rocuronium-induced Neuromuscular Block With Sugammadex in Heart Failure Patients
Although anticholinesterase reversal agents have been used in combination with anticholinergic drugs for over half a century, it has been suggested that they should be used with caution in patients with underlying cardiovascular disease. As sugammadex has no endogenous targets, it is unlikely to cause any adverse cardiovascular effects. This selective relaxant binding agent is specifically designed to encapsulate rocuronium, which can, therefore, promptly restore neuromuscular function regardless of any levels of NMB as the dose is increased.
Some reports, however, suggest that sugammadex may have increased time to effect in some patient populations like the elderly, patients in intensive care and renal failure patients. A less dynamic circulation and increased transfer time to the effector site in these subjects are likely explanations for this effect. The present trial was designed to assess the safety and efficacy of sugammadex 2.0 mg kg-1 for the reversal of rocuronium-induced NMB in patients with heart failure.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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-
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Aalst, Belgique, 9300
- OLV Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- aged 18 yr or older
- categorized as American Society of Anesthesiologists class 3-4 and New York Heart Association class 2-4
- with an ejection fraction <25%
- scheduled to undergo elective surgery for cardiac resynchronization therapy, an automated implantable cardioverter-defibrillator (ICD), or battery replacement of an ICD or biventricular pacemaker, during general anaesthesia.
Exclusion Criteria:
- expected to have a difficult intubation for anatomic reasons
- they had a neuromuscular disorder
- a personal or family history of malignant hyperthermia
- or known allergy to medication used during general anaesthesia
- not able or willing to give written informed consent.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Sugammadex
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After the induction of anaesthesia, monitoring neuromuscular function is initiated and performed continuously using the TOF-Watch SX (Organon Ireland Ltd, Ireland) at the thumb.
Repetitive train-of four (TOF) stimulation is applied every 15 s at the ulnar nerve until the end of anaesthesia, at least until recovery of the TOF ratio to 0.9 after administration of sugammadex.
Each patient receives a single IV bolus dose of rocuronium 0.6 mg kg-1, after which tracheal intubation is performed.
Maintenance doses of rocuronium 0.1 mg kg-1, are permitted as required and administered at the reappearance of the second twitch in the TOF.
On reappearance of the second twitch at the end of surgery, patients receive a single IV bolus dose of sugammadex, 2.0 mg kg-1, for reversal.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
The time from start of sugammadex administration to recovery of the train-of-four (TOF) ratio to 0.9.
Délai: Participants will be followed for the duration of recovery from neuromuscular block, an expected average of 10min
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Participants will be followed for the duration of recovery from neuromuscular block, an expected average of 10min
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
The time from start of sugammadex administration to recovery of the TOF ratio to 0.7 and 0.8.
Délai: Participants will be followed for the duration of recovery from neuromuscular block, an expected average of 10min
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Participants will be followed for the duration of recovery from neuromuscular block, an expected average of 10min
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Adverse hemodynamic events.
Délai: From anesthesia induction until 3h after arrival in the postanaesthesia care unit (PACU).
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From anesthesia induction until 3h after arrival in the postanaesthesia care unit (PACU).
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Adverse respiratory events (SpO2 <90% and/or signs of airway obstruction).
Délai: From arrival in the PACU until 30min thereafter.
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From arrival in the PACU until 30min thereafter.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Guy Cammu, MD, PhD, OLV Hospital, Anesthesiology and CCM, Aalst, Belgium
Publications et liens utiles
Publications générales
- Staals LM, Snoeck MM, Driessen JJ, Flockton EA, Heeringa M, Hunter JM. Multicentre, parallel-group, comparative trial evaluating the efficacy and safety of sugammadex in patients with end-stage renal failure or normal renal function. Br J Anaesth. 2008 Oct;101(4):492-7. doi: 10.1093/bja/aen216. Epub 2008 Jul 23.
- Dahl V, Pendeville PE, Hollmann MW, Heier T, Abels EA, Blobner M. Safety and efficacy of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in cardiac patients undergoing noncardiac surgery. Eur J Anaesthesiol. 2009 Oct;26(10):874-84. doi: 10.1097/EJA.0b013e32832c605b.
- Sorgenfrei IF, Norrild K, Larsen PB, Stensballe J, Ostergaard D, Prins ME, Viby-Mogensen J. Reversal of rocuronium-induced neuromuscular block by the selective relaxant binding agent sugammadex: a dose-finding and safety study. Anesthesiology. 2006 Apr;104(4):667-74. doi: 10.1097/00000542-200604000-00009.
- Suzuki T, Kitajima O, Ueda K, Kondo Y, Kato J, Ogawa S. Reversibility of rocuronium-induced profound neuromuscular block with sugammadex in younger and older patients. Br J Anaesth. 2011 Jun;106(6):823-6. doi: 10.1093/bja/aer098. Epub 2011 Apr 29.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- B126201112363
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