Efficacy and Safety of Sugammadex in Renal Diseased Patients

Phase 4

Completed

• Conditions: Kidney Failure, Chronic; Neuromuscular Blockade
• Interventions: Drug: Sugammadex (4 mg/Kg)

• Registration Number: NCT01785758
• Lead Sponsor: Federal University of São Paulo

Brief 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.

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-02
• Study First Submitted: 2013-02-03
• Study First Submitted QC: 2013-02-05
• Last Update Submitted: 2013-02-05
• Study First Posted: 2013-02-07
• Last Update Posted: 2013-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• age between 18 and 65 years old
• end-stage renal disease defined by clearance of creatinine < 30 ml/min
• normal renal function defined by clearance if creatinine > 90 ml/min
• candidates to elective surgical procedures (control group) or kidney transplantation (renal group) under general anaesthesia

Exclusion Criteria

• pregnant and breastfeeding women
• patients with known or suspected neuromuscular disorders
• patients with hepatic disfunction
• a history of malignant hyperthermia
• allergy to narcotics, rocuronium or other medication used during general anaesthesia
• patients receiving medication known to interfere with the action of rocuronium (amino glycoside antibiotics, anticonvulsants, or magnesium)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Sugammadex (4 mg/Kg)	Sugammadex (4mg/Kg) single dose to reverse profound neuromuscular blockade
Renal Group	Sugammadex (4 mg/Kg)	Sugammadex (4mg/Kg) single dose to reverse profound neuromuscular blockade

Primary Outcome Measures

Name	Time	Method
Time from administration of sugammadex to recovery of the train-of-four ratio (TOF) to 0.9	2 hours

Secondary Outcome Measures

Name	Time	Method
Time from administration of sugammadex to recovery of the train-of-four ratio (TOF) to 0.7 and 0.8	2 hours

Trial Locations

Locations (1)

Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos; 🇧🇷 São Paulo, SP, Brazil