Sugammadex versus neostigmine reversal of moderate rocuronium-induced neuromuscular blockade in Korean patients.
10.4097/kjae.2013.65.6.501
- Author:
Tiffany WOO
1
;
Kyo Sang KIM
;
Yon Hee SHIM
;
Mi Kyeong KIM
;
Suk Min YOON
;
Young Jin LIM
;
Hong Seuk YANG
;
Phillip PHIRI
;
Jin Young CHON
Author Information
1. Clinical Development, Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA. tiffany.woo@merck.com
- Publication Type:Original Article ; Randomized Controlled Trial
- Keywords:
Caucasian;
Korean;
Neostigmine;
Neuromuscular blockade;
Rocuronium;
Sugammadex
- MeSH:
Anesthesia, General;
Glycopyrrolate;
Humans;
Intubation;
Neostigmine*;
Neuromuscular Blockade*;
Recurrence
- From:Korean Journal of Anesthesiology
2013;65(6):501-507
- CountryRepublic of Korea
- Language:English
-
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.
