Kidney Failure, Chronic, Neuromuscular Blockade
Conditions
Keywords
complications, renal;, kidney, failure;, neuromuscular block, antagonism;, neuromuscular block, rocuronium;, safety, drug, sugammadex
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.
Interventions
DRUGSugammadex (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
Sponsors
Hospital General Universitario Santa Lucía
Federal University of São Paulo
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from administration of sugammadex to recovery of the train-of-four ratio (TOF) to 0.9 | 2 hours |
Secondary
| Measure | Time frame |
|---|---|
| Time from administration of sugammadex to recovery of the train-of-four ratio (TOF) to 0.7 and 0.8 | 2 hours |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reoccurrence of neuromuscular blockade | 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 |
Countries
Brazil
Outcome results
None listed