Efficacy and Safety of Sugammadex in Renal Diseased Patients

F

Federal University of São Paulo

Status and phase

Completed
Phase 4

Conditions

Neuromuscular Blockade
Kidney Failure, Chronic

Treatments

Drug: Sugammadex (4 mg/Kg)

Study type

Interventional

Funder types

Other

Identifiers

NCT01785758
CEP 1277/11 (Other Identifier)
Sugamadex01

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Renal Group
Experimental group
Description:
Sugammadex (4mg/Kg) single dose to reverse profound neuromuscular blockade
Treatment:
Drug: Sugammadex (4 mg/Kg)
Control group
Active Comparator group
Description:
Sugammadex (4mg/Kg) single dose to reverse profound neuromuscular blockade
Treatment:
Drug: Sugammadex (4 mg/Kg)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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