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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.EJ

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.

DESIGN

A prospective clinical trial.

SETTING

Two university hospitals, from 1 October 2011 to 31 January 2012.

PATIENTS

Forty patients undergoing kidney transplant: 20 with renal failure [creatinine clearance (ClCr) <30 ml min] and 20 control patients (ClCr >90 ml min).

INTERVENTION

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.

MAIN OUTCOME MEASURES

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.

CONCLUSION

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.

TRIAL REGISTRATION

Clinicaltrials.gov identifier NCT01785758.

Authors+Show Affiliations

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).No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26225497

Citation

de Souza, Camila M., et al. "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." European Journal of Anaesthesiology, vol. 32, no. 10, 2015, pp. 681-6.
de Souza CM, Tardelli MA, Tedesco H, et al. 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;32(10):681-6.
de Souza, C. M., Tardelli, M. A., Tedesco, H., Garcia, N. N., Caparros, M. P., Alvarez-Gomez, J. A., & de Oliveira Junior, I. S. (2015). 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. European Journal of Anaesthesiology, 32(10), 681-6. https://doi.org/10.1097/EJA.0000000000000312
de Souza CM, et al. 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;32(10):681-6. PubMed PMID: 26225497.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - de Souza,Camila M, AU - Tardelli,Maria A, AU - Tedesco,Helio, AU - Garcia,Natalia N, AU - Caparros,Mario P, AU - Alvarez-Gomez,Jose A, AU - de Oliveira Junior,Itamar S, PY - 2015/7/31/entrez PY - 2015/8/1/pubmed PY - 2016/6/2/medline SP - 681 EP - 6 JF - European journal of anaesthesiology JO - Eur J Anaesthesiol VL - 32 IS - 10 N2 - 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. DESIGN: A prospective clinical trial. SETTING: Two university hospitals, from 1 October 2011 to 31 January 2012. PATIENTS: Forty patients undergoing kidney transplant: 20 with renal failure [creatinine clearance (ClCr) <30 ml min] and 20 control patients (ClCr >90 ml min). INTERVENTION: 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. MAIN OUTCOME MEASURES: 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. CONCLUSION: 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. TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT01785758. SN - 1365-2346 UR - https://www.unboundmedicine.com/medline/citation/26225497/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_ L2 - https://doi.org/10.1097/EJA.0000000000000312 DB - PRIME DP - Unbound Medicine ER -