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Efficacy and Safety of Sugammadex in Renal Diseased Patients

Primary Purpose

Kidney Failure, Chronic, Neuromuscular Blockade

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Sugammadex (4 mg/Kg)

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic focused on measuring complications, renal;, kidney, failure;, neuromuscular block, antagonism;, neuromuscular block, rocuronium;, safety, drug, sugammadex

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Renal Group

Control group

Arm Description

Sugammadex (4mg/Kg) single dose to reverse profound neuromuscular blockade

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01785758

First Posted

February 3, 2013

Last Updated

February 5, 2013

Sponsor

Federal University of São Paulo

Collaborators

Hospital General Universitario Santa Lucía

1. Study Identification

Unique Protocol Identification Number

NCT01785758

Brief Title

Efficacy and Safety of Sugammadex in Renal Diseased Patients

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 Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of São Paulo

Collaborators

Hospital General Universitario Santa Lucía

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Failure, Chronic, Neuromuscular Blockade

Keywords

complications, renal;, kidney, failure;, neuromuscular block, antagonism;, neuromuscular block, rocuronium;, safety, drug, sugammadex

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Renal Group

Arm Type

Experimental

Arm Description

Sugammadex (4mg/Kg) single dose to reverse profound neuromuscular blockade

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

Sugammadex (4mg/Kg) single dose to reverse profound neuromuscular blockade

Intervention Type

Drug

Intervention Name(s)

Sugammadex (4 mg/Kg)

Other Intervention Name(s)

Bridion

Intervention Description

Sugammadex administered at the end of surgical procedure, once skin suture had been finished, to reverse profound neuromuscular blockade induced and maintained with rocuronium

Primary Outcome Measure Information:

Title

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

Time Frame

2 hours

Secondary Outcome Measure Information:

Title

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 Pre-specified Outcome Measures:

Title

Reoccurrence of neuromuscular blockade

Description

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

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Camila M Souza, MD

Organizational Affiliation

Federal University of Sao Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos

City

São Paulo

State/Province

ZIP/Postal Code

04038002

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

18653492

Citation

Staals LM, Snoeck MM, Driessen JJ, Flockton EA, Heeringa M, Hunter JM. Multicentre, parallel-group, comparative trial evaluating the efficacy and safety of sugammadex in patients with end-stage renal failure or normal renal function. Br J Anaesth. 2008 Oct;101(4):492-7. doi: 10.1093/bja/aen216. Epub 2008 Jul 23.

Results Reference

background

PubMed Identifier

20007792

Citation

Staals LM, Snoeck MM, Driessen JJ, van Hamersvelt HW, Flockton EA, van den Heuvel MW, Hunter JM. Reduced clearance of rocuronium and sugammadex in patients with severe to end-stage renal failure: a pharmacokinetic study. Br J Anaesth. 2010 Jan;104(1):31-9. doi: 10.1093/bja/aep340.

Results Reference

background

PubMed Identifier

26225497

Citation

de Souza CM, Tardelli MA, Tedesco H, Garcia NN, Caparros MP, Alvarez-Gomez JA, de Oliveira Junior IS. Efficacy and safety of sugammadex in the reversal of deep neuromuscular blockade induced by rocuronium in patients with end-stage renal disease: A comparative prospective clinical trial. Eur J Anaesthesiol. 2015 Oct;32(10):681-6. doi: 10.1097/EJA.0000000000000312.

Results Reference

derived

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Efficacy and Safety of Sugammadex in Renal Diseased Patients

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