A Phase 4 interventional study of Sugammadex (4 mg/Kg) in Kidney Failure, Chronic and Neuromuscular Blockade, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-02-07.
Sponsored by Federal University of São Paulo · Phase 4, Interventional, and Treatment
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.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 40 is close to the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
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Sugammadex (4mg/Kg) single dose to reverse profound neuromuscular blockade
Drug: Sugammadex (4 mg/Kg)
Sugammadex (4mg/Kg) single dose to reverse profound neuromuscular blockade
Drug: Sugammadex (4 mg/Kg)
Sugammadex administered at the end of surgical procedure, once skin suture had been finished, to reverse profound neuromuscular blockade induced and maintained with rocuronium
Also known as: Bridion
Time from administration of sugammadex to recovery of the train-of-four ratio (TOF) to 0.9
Time frame: 2 hours
Time from administration of sugammadex to recovery of the train-of-four ratio (TOF) to 0.7 and 0.8
Time frame: 2 hours
Reoccurrence of neuromuscular blockade
Patients will be monitored for evidence of reoccurrence of neuromuscular blockade for the first two hours after administration of sugammadex and clinically reevaluated after 24 hours
Time frame: 24 hours
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo