Efficacy and Safety of Sugammadex in Renal Diseased Patients

Kidney Failure, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785758
• Other study ID #: Sugamadex01
• Secondary ID: CEP 1277/11
• Status: Completed
• Phase: Phase 4
• First received: February 3, 2013
• Last updated: February 5, 2013
• Start date: October 2011
• Est. completion date: January 2012

Study information

• Verified date: February 2013
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Neuromuscular Blockade
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Hospital General Universitario Santa Lucía

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reoccurrence of neuromuscular blockade	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	Yes
Primary	Time from administration of sugammadex to recovery of the train-of-four ratio (TOF) to 0.9		2 hours	No
Secondary	Time from administration of sugammadex to recovery of the train-of-four ratio (TOF) to 0.7 and 0.8		2 hours	No