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Completed

NCT Number: NCT01785758

Efficacy and Safety of Sugammadex in Renal Diseased 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.

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Key information

Conditions

Kidney Failure, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Neuromuscular Blockade Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos

São Paulo, 04038002, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sugammadex (4 mg/Kg)

Drug

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

Primary outcomes

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

    Time frame: 2 hours

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Hospital General Universitario Santa Lucía

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 7, 2013
Registry last updated
Feb 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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