Efficacy and Safety of Sugammadex in Renal Diseased Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Kidney Failure, Chronic, Neuromuscular Blockade

Intervention / Treatment
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* Drug: Sugammadex (4 mg/Kg)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Group<br>Sugammadex (4mg/Kg) single dose to reverse profound neuromuscular blockade | Drug: Sugammadex (4 mg/Kg)<br>* Sugammadex administered at the end of surgical procedure, once skin suture had been finished, to reverse profound neuromuscular blockade induced and maintained with rocuronium<br>* Other names: Bridion;|
| Active Comparator: Control group<br>Sugammadex (4mg/Kg) single dose to reverse profound neuromuscular blockade | Drug: Sugammadex (4 mg/Kg)<br>* Sugammadex administered at the end of surgical procedure, once skin suture had been finished, to reverse profound neuromuscular blockade induced and maintained with rocuronium<br>* Other names: Bridion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from administration of sugammadex to recovery of the train-of-four ratio (TOF) to 0.9 |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from administration of sugammadex to recovery of the train-of-four ratio (TOF) to 0.7 and 0.8 |  | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complications, renal;, kidney, failure;, neuromuscular block, antagonism;, neuromuscular block, rocuronium;, safety, drug, sugammadex