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Efficacy and Safety of Sugammadex in Renal Diseased Patients

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ClinicalTrials.gov Identifier: NCT01785758
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : February 7, 2013
Sponsor:
Collaborator:
Hospital General Universitario Santa Lucía
Information provided by (Responsible Party):
Camila Machado de Souza, 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.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Neuromuscular Blockade Drug: Sugammadex (4 mg/Kg) Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure

Arm Intervention/treatment
Experimental: Renal Group
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
Other Name: Bridion

Active Comparator: Control group
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
Other Name: Bridion




Primary Outcome Measures :
  1. Time from administration of sugammadex to recovery of the train-of-four ratio (TOF) to 0.9 [ Time Frame: 2 hours ]

Secondary Outcome Measures :
  1. Time from administration of sugammadex to recovery of the train-of-four ratio (TOF) to 0.7 and 0.8 [ Time Frame: 2 hours ]

Other Outcome Measures:
  1. Reoccurrence of neuromuscular blockade [ Time Frame: 24 hours ]
    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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785758


Locations
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Brazil
Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos
São Paulo, SP, Brazil, 04038002
Sponsors and Collaborators
Federal University of São Paulo
Hospital General Universitario Santa Lucía
Investigators
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Principal Investigator: Camila M Souza, MD Federal University of Sao Paulo

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Camila Machado de Souza, MD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01785758     History of Changes
Other Study ID Numbers: Sugamadex01
CEP 1277/11 ( Other Identifier: Federal University of Sao Paulo - Ethics Committee )
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013
Keywords provided by Camila Machado de Souza, Federal University of São Paulo:
complications, renal;
kidney, failure;
neuromuscular block, antagonism;
neuromuscular block, rocuronium;
safety, drug
sugammadex
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs