Sugammadex and Heart Failure

O

Onze Lieve Vrouw Hospital

Status and phase

Completed
Phase 3

Conditions

Postoperative Neuromuscular Block

Treatments

Drug: Sugammadex

Study type

Interventional

Funder types

Other

Identifiers

NCT01509651
B126201112363

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

12 participants in 1 patient group

Sugammadex
Experimental group
Treatment:
Drug: Sugammadex

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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