Comparison of Sugammadex With Neostigmine as Reversal Agents for Rocuronium at Reappearance of T2 (Study P06101)

Summary

This is a randomized, active-controlled, parallel-group, single-dose, multi-site, safety-assessor blinded study comparing sugammadex to neostigmine for reversal of neuromuscular blockade in Korean subjects undergoing elective surgical procedures under general anesthesia that require rocuronium for neuromuscular blockade. Study medication will be administered at reappearance of T2. Time to recovery will be measured from start of study medication administration to recovery of the T4/T1 ratio of 0.9. The primary hypothesis is that the time to recovery of the T4/T1 ratio of 0.9 is shorter with sugammadex than with neostigmine.

Timeline

Start

2010-02-01

Primary completion

2010-08-20

Completion

2010-08-20

Outcome

Met primary endpoint

registry analysis (superiority or other test); Sugammadex vs Neostigmine; p <0.0001; Mean Difference (Final Values) 8.1 (95% CI 6.8 to 9.6); ANOVA NCT01050543 ↗

paper 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). PMID 24427455 ↗

Publications

• Results Woo T, Kim KS, Shim YH, Kim MK, Yoon SM, Lim YJ, Yang HS, Phiri P, Chon JY. Sugammadex versus neostigmine reversal of moderate rocuronium-induced neuromuscular blockade in Korean patients. Korean J Anesthesiol. 2013 Dec;65(6):501-7. doi: 10.4097/kjae.2013.65.6.501. Epub 2013 Dec 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Neostigmine	Other / unclassified	50 ug/kg	Intravenous
Subject	Sugammadex	Other / unclassified	2 mg/kg	Intravenous
Background	Glycopyrrolate	Small molecule	10 ug/kg	Intravenous

Indications

No indication recorded.