Efficacy and Safety of Sugammadex in Renal Diseased Patients

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)