Kidney Failure, Chronic Clinical Trial
Official title:
Efficacy and Safety of Sugammadex (Bridion™) in the Reversal of Profound Rocuronium-induced Neuromuscular Blockade in Patients With End-stage Renal Failure: Comparison With Healthy Patients
The purpose of this study is to determine whether sugammadex reverses a profound neuromuscular blockade induced by rocuronium in patients with end-stage renal disease just as effectively and safely as it does in patients with normal renal function.
Sugammadex antagonizes rocuronium induced neuromuscular blockade by encapsulating the
molecules of this agent in the plasma and originating a complex which is highly stable, and
mainly eliminated by the kidneys. In patients with end stage renal disease, this complex
remains in the circulation for days. Previous studies have shown that sugammadex adequately
reverses the blockade induced by rocuronium in such patients, and no evidence of recurrence
was observed after a dosis of 2 mg/Kg administered to reverse a moderate level of blockade.
To our knowledge, nothing has been published so far on the reversal of profound blockade by
sugammadex in patients with renal failure.
The aim of our study was to evaluate the efficacy and safety of sugammadex in the reversal
of profound neuromuscular block (NMB) induced by rocuronium in patients with end-stage renal
failure and compare it to patients with normal renal function.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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