Efficacy and Safety of Sugammadex in Renal Diseased Patients

February 5, 2013 updated by: Camila Machado de Souza, Federal University of São Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04038002
        • Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Bridion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Hospital General Universitario Santa Lucia

Investigators

  • Principal Investigator: Camila M Souza, MD, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

February 3, 2013

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Estimate)

February 7, 2013

Last Update Submitted That Met QC Criteria

February 5, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sugamadex01
  • CEP 1277/11 (Other Identifier: Federal University of Sao Paulo - Ethics Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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