title: 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.
abstract: BACKGROUND
  Renal failure affects the pharmacology of nondepolarizing neuromuscular blockers making recovery of neuromuscular function unpredictable. Sugammadex antagonises rocuronium-induced neuromuscular blockade by encapsulating rocuronium, creating a stable complex molecule that is mainly excreted by the kidneys. Previous studies suggest that sugammadex is effective in reversing moderate neuromuscular block in the presence of renal failure, but no data are available regarding reversal of profound neuromuscular block in patients with renal failure.
  
  
  OBJECTIVE
  The objective of this study is to compare the efficacy and safety of sugammadex in reversing profound neuromuscular block induced by rocuronium in patients with end-stage renal disease and those with normal renal function.
  
  
  METHODS
  A prospective clinical trial.
  
  
  METHODS
  Two university hospitals, from 1 October 2011 to 31 January 2012.
  
  
  METHODS
  Forty patients undergoing kidney transplant: 20 with renal failure [creatinine clearance (ClCr) <30 ml min] and 20 control patients (ClCr >90 ml min).
  
  
  METHODS
  Neuromuscular monitoring was performed by acceleromyography and train-of-four (TOF) stimulation. Profound neuromuscular block (posttetanic count, one to three responses) was maintained during surgery. Sugammadex 4 mg kg was administered on completion of skin closure. Recovery of the TOF ratio to 0.9 was recorded. Monitoring of neuromuscular function continued in the postanesthesia care unit for a further 2 h.
  
  
  METHODS
  The efficacy of sugammadex was evaluated by the time taken for the TOF ratio to recover to 0.9. The safety of sugammadex was assessed by monitoring for recurrence of neuromuscular block every 15 min for 2 h. Secondary variables were time to recovery of TOF ratio to 0.7 and 0.8.
  
  
  RESULTS
  After sugammadex administration, the mean time for recovery of the TOF ratio to 0.9 was prolonged in the renal failure group (5.6 ± 3.6 min) compared with the control group (2.7 ± 1.3 min, P = 0.003). No adverse events or evidence of recurrence of neuromuscular block were observed.
  
  
  CONCLUSIONS
  In patients with renal failure, sugammadex (4 mg kg) effectively and safely reversed profound rocuronium induced neuromuscular block, but the recovery was slower than healthy patients.
  
  
  BACKGROUND
  Clinicaltrials.gov identifier NCT01785758.
authors.affiliation: From the Division of Nephrology, Hospital do Rim e Hipertensão (CMS, HT), the Division of Anesthesiology, Pain and Intensive Care Medicine/Universidade Federal de São Paulo - UNIFESP, Sao Paulo, Brazil (MAT, ISO-J), and the University Hospital Sta Lucia, Cartagena, Spain (NNG, MPC, JAA-G).
authors.forename: Camila M
authors.initials: CM
authors.lastname: de Souza
authors.forename: Maria A
authors.initials: MA
authors.lastname: Tardelli
authors.forename: Helio
authors.initials: H
authors.lastname: Tedesco
authors.forename: Natalia N
authors.initials: NN
authors.lastname: Garcia
authors.forename: Mario P
authors.initials: MP
authors.lastname: Caparros
authors.forename: Jose A
authors.initials: JA
authors.lastname: Alvarez-Gomez
authors.forename: Itamar S
authors.initials: IS
authors.lastname: de Oliveira Junior
mesh_terms: D061725:Accelerometry; D000328:Adult; D000732:Androstanols / Q000008:administration & dosage*; D016022:Case-Control Studies; D005260:Female; D006785:Hospitals, University; D006801:Humans; D007676:Kidney Failure, Chronic / Q000503:physiopathology*; D016030:Kidney Transplantation / Q000379:methods; D008297:Male; D008875:Middle Aged; D019148:Neuromuscular Blockade / Q000379:methods*; D061886:Neuromuscular Monitoring; D003473:Neuromuscular Nondepolarizing Agents / Q000008:administration & dosage; D011446:Prospective Studies; D000077123:Rocuronium; D000077122:Sugammadex; D013997:Time Factors; D047408:gamma-Cyclodextrins / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000732:Androstanols; D003473:Neuromuscular Nondepolarizing Agents; D047408:gamma-Cyclodextrins; D000077122:Sugammadex; D000077123:Rocuronium