Clinical trial NCT01785758: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Failure, Chronic
Neuromuscular Blockade
Keywords: complications, renal;
kidney, failure;
neuromuscular block, antagonism;
neuromuscular block, rocuronium;
safety, drug
sugammadex
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Hospital General Universitario Santa Lucía
First posted: 2013-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Time from administration of sugammadex to recovery of the train-of-four ratio (TOF) to 0.9
timeFrame: 2 hours
Secondary outcomes:
measure: Time from administration of sugammadex to recovery of the train-of-four ratio (TOF) to 0.7 and 0.8
timeFrame: 2 hours
Other outcomes:
measure: Reoccurrence of neuromuscular blockade
timeFrame: 24 hours
Locations:
city: São Paulo
country: Brazil
facility: Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Camila M Souza, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.