- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Aalst, Belgien, 9300
- OLV Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
The time from start of sugammadex administration to recovery of the train-of-four (TOF) ratio to 0.9.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
The time from start of sugammadex administration to recovery of the TOF ratio to 0.7 and 0.8.
Tidsramme: 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.
Tidsramme: 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).
Tidsramme: From arrival in the PACU until 30min thereafter.
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From arrival in the PACU until 30min thereafter.
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Guy Cammu, MD, PhD, OLV Hospital, Anesthesiology and CCM, Aalst, Belgium
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B126201112363
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