drugset / Trial / NCT00675792

Comparison of Sugammadex Administered at 1-2 Post Tetanic Counts (PTCs) or Better With Neostigmine Administered as Per Standard of Care to Reverse Rocuronium-Induced Neuromuscular Blockade in Adults Undergoing Elective Open Abdominal Procedure (19.4.334) (P05774)

NCT00675792

Phase 3 Completed 100 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupSingle-blindTreatment

Summary

The primary purpose of this study is to compare the incidence of residual neuromuscular blockade at the time of tracheal extubation after reversal of rocuronium bromide-induced neuromuscular blockade by 4 mg/kg sugammadex with that of 50 µg/kg neostigmine. Residual neuromuscular blockade is defined as the fourth twitch to first twitch (T4/T1) ratio of \< 0.90.

Timeline

Start
2008-05
Primary completion
2008-09
Completion
2008-09

Publications

  • Results Sabo D, Jones RK, Berry J, Sloan T, Chen J-Y, Morte JB, Groudine S. Residual neuromuscular blockade at extubation: a randomized comparison of sugammadex and neostigmine reversal of rocuronium-induced blockade in patients undergoing abdominal surgery. J Anesthe Clin Res. 2011;2:140.

Drugs

EvaluationDrugModalityDoseRoute
Comparator Neostigmine Other / unclassified 50 ug/kg
Subject Sugammadex Other / unclassified 4 mg/kg
Background Rocuronium Other / unclassified 0.15 mg/kg

Indications

No indication recorded.