Korean J Anesthesiol.  2013 Dec;65(6):501-507. 10.4097/kjae.2013.65.6.501.

Sugammadex versus neostigmine reversal of moderate rocuronium-induced neuromuscular blockade in Korean patients

Affiliations
  • 1Clinical Development, Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA. tiffany.woo@merck.com
  • 2Department of Anesthesiology and Pain Medicine, College of Medicine, Hanyang University, Seoul, Korea.
  • 3Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea.
  • 4Department of Anesthesiology and Pain Medicine, College of Medicine, Kyung Hee University Hospital, Seoul, Korea.
  • 5Department of Anesthesiology and Pain Medicine, Korea University Anam Hospital, Seoul, Korea.
  • 6Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Korea.
  • 7Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  • 8Department of Anesthesiology and Pain Medicine, The Catholic University of Korea, School of Medicine, St. Mary's Hospital, Seoul, Korea.

Abstract

BACKGROUND
Rapid and complete reversal of neuromuscular blockade (NMB) is desirable at the end of surgery. Sugammadex reverses rocuronium-induced NMB by encapsulation. It is well tolerated in Caucasian patients, providing rapid reversal of moderate (reappearance of T2) rocuronium-induced NMB. We investigated the efficacy and safety of sugammadex versus neostigmine in Korean patients.
METHODS
This randomized, safety assessor-blinded trial (NCT01050543) included Korean patients undergoing general anesthesia. Rocuronium 0.6 mg/kg was given prior to intubation with maintenance doses of 0.1-0.2 mg/kg as required. Patients received sugammadex 2.0 mg/kg or neostigmine 50 microg/kg with glycopyrrolate 10 microg/kg to reverse the NMB at the reappearance of T2, after the last rocuronium dose. The primary efficacy endpoint was the time from sugammadex or neostigmine administration to recovery of the train-of-four (TOF) ratio to 0.9. The safety of these medications was also assessed.
RESULTS
Of 128 randomized patients, 118 had evaluable data (n = 59 in each group). The geometric mean (95% confidence interval) time to recovery of the TOF ratio to 0.9 was 1.8 (1.6, 2.0) minutes in the sugammadex group and 14.8 (12.4, 17.6) minutes in the neostigmine group (P < 0.0001). Sugammadex was generally well tolerated, with no evidence of residual or recurrence of NMB; four patients in the neostigmine group reported adverse events possibly indicative of inadequate NMB reversal.
CONCLUSIONS
Sugammadex was well tolerated and provided rapid reversal of moderate rocuronium-induced NMB in Korean patients, with a recovery time 8.1 times faster than neostigmine. These results are consistent with those reported for Caucasian patients.

Keyword

Caucasian; Korean; Neostigmine; Neuromuscular blockade; Rocuronium; Sugammadex

MeSH Terms

Anesthesia, General
Glycopyrrolate
Humans
Intubation
Neostigmine*
Neuromuscular Blockade*
Recurrence
Glycopyrrolate
Neostigmine

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