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Multicentre, parallel-group, comparative trial evaluating the efficacy and safety of sugammadex in patients with end-stage renal failure or normal renal function.
Br J Anaesth. 2008 Oct; 101(4):492-7.BJ

Abstract

BACKGROUND

Sugammadex, a modified gamma-cyclodextrin, is the first selective relaxant binding agent that specifically encapsulates the steroidal neuromuscular blocking agent, rocuronium. The action of rocuronium is prolonged in patients with renal failure. As sugammadex is primarily cleared renally, this phase III trial investigated the efficacy and safety of sugammadex for reversal of rocuronium-induced neuromuscular block (NMB) in patients with end-stage renal failure.

METHODS

Thirty adult patients were studied: 15 renally impaired [creatinine clearance (CL(CR)) <30 ml min(-1)] and 15 controls (CL(CR)>80 ml min(-1)). Anaesthesia was induced and maintained using i.v. opiates and propofol. Neuromuscular monitoring was performed by acceleromyography and train-of-four (TOF) nerve stimulation. Rocuronium (0.6 mg kg(-1)) was given, followed by a single i.v. dose of sugammadex (2.0 mg kg(-1)) at reappearance of the second twitch of the TOF. The primary efficacy variable was time from administration of sugammadex to recovery of the TOF ratio to 0.9. Safety variables included clinical evidence of reoccurrence of NMB.

RESULTS

After sugammadex administration, the mean (sd) time to recovery of the TOF ratio to 0.9 was 2.0 (0.72) min in renal patients and 1.65 (0.63) min in controls (NS). Recurrence of NMB was not observed in any patient. No sugammadex-related serious adverse events were reported.

CONCLUSIONS

Sugammadex administered at reappearance of T(2) rapidly and effectively reverses NMB induced by rocuronium in renal failure and healthy patients. Sugammadex was well tolerated by all patients. Further safety studies on sugammadex in patients with severe renal impairment are warranted.

Authors+Show Affiliations

Department of Anaesthesiology, Pain and Palliative Medicine, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands. l.staals@anes.umcn.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18653492

Citation

Staals, L M., et al. "Multicentre, Parallel-group, Comparative Trial Evaluating the Efficacy and Safety of Sugammadex in Patients With End-stage Renal Failure or Normal Renal Function." British Journal of Anaesthesia, vol. 101, no. 4, 2008, pp. 492-7.
Staals LM, Snoeck MM, Driessen JJ, et al. Multicentre, parallel-group, comparative trial evaluating the efficacy and safety of sugammadex in patients with end-stage renal failure or normal renal function. Br J Anaesth. 2008;101(4):492-7.
Staals, L. M., Snoeck, M. M., Driessen, J. J., Flockton, E. A., Heeringa, M., & Hunter, J. M. (2008). Multicentre, parallel-group, comparative trial evaluating the efficacy and safety of sugammadex in patients with end-stage renal failure or normal renal function. British Journal of Anaesthesia, 101(4), 492-7. https://doi.org/10.1093/bja/aen216
Staals LM, et al. Multicentre, Parallel-group, Comparative Trial Evaluating the Efficacy and Safety of Sugammadex in Patients With End-stage Renal Failure or Normal Renal Function. Br J Anaesth. 2008;101(4):492-7. PubMed PMID: 18653492.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multicentre, parallel-group, comparative trial evaluating the efficacy and safety of sugammadex in patients with end-stage renal failure or normal renal function. AU - Staals,L M, AU - Snoeck,M M J, AU - Driessen,J J, AU - Flockton,E A, AU - Heeringa,M, AU - Hunter,J M, Y1 - 2008/07/23/ PY - 2008/7/26/pubmed PY - 2008/10/23/medline PY - 2008/7/26/entrez SP - 492 EP - 7 JF - British journal of anaesthesia JO - Br J Anaesth VL - 101 IS - 4 N2 - BACKGROUND: Sugammadex, a modified gamma-cyclodextrin, is the first selective relaxant binding agent that specifically encapsulates the steroidal neuromuscular blocking agent, rocuronium. The action of rocuronium is prolonged in patients with renal failure. As sugammadex is primarily cleared renally, this phase III trial investigated the efficacy and safety of sugammadex for reversal of rocuronium-induced neuromuscular block (NMB) in patients with end-stage renal failure. METHODS: Thirty adult patients were studied: 15 renally impaired [creatinine clearance (CL(CR)) <30 ml min(-1)] and 15 controls (CL(CR)>80 ml min(-1)). Anaesthesia was induced and maintained using i.v. opiates and propofol. Neuromuscular monitoring was performed by acceleromyography and train-of-four (TOF) nerve stimulation. Rocuronium (0.6 mg kg(-1)) was given, followed by a single i.v. dose of sugammadex (2.0 mg kg(-1)) at reappearance of the second twitch of the TOF. The primary efficacy variable was time from administration of sugammadex to recovery of the TOF ratio to 0.9. Safety variables included clinical evidence of reoccurrence of NMB. RESULTS: After sugammadex administration, the mean (sd) time to recovery of the TOF ratio to 0.9 was 2.0 (0.72) min in renal patients and 1.65 (0.63) min in controls (NS). Recurrence of NMB was not observed in any patient. No sugammadex-related serious adverse events were reported. CONCLUSIONS: Sugammadex administered at reappearance of T(2) rapidly and effectively reverses NMB induced by rocuronium in renal failure and healthy patients. Sugammadex was well tolerated by all patients. Further safety studies on sugammadex in patients with severe renal impairment are warranted. SN - 1471-6771 UR - https://www.unboundmedicine.com/medline/citation/18653492/Multicentre_parallel_group_comparative_trial_evaluating_the_efficacy_and_safety_of_sugammadex_in_patients_with_end_stage_renal_failure_or_normal_renal_function_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0007-0912(17)34162-4 DB - PRIME DP - Unbound Medicine ER -