NCT01785758

Efficacy and Safety of Sugammadex in Renal Diseased Patients

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Kidney Failure, Chronic
• Neuromuscular Blockade

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2013-02-07
• Last updated: 2013-02-07

Locations

1 site across 1 country: Brazil