drugset / Trial / NCT01509651

Sugammadex and Heart Failure

NCT01509651

Phase 3 Completed 12 enrolled Onze Lieve Vrouw Hospital
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2012-01
Primary completion
2012-03
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Sugammadex Other / unclassified 2 mg/kg Intravenous

Indications

No indication recorded.