drugset / Trial / NCT01422304

Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038)

NCT01422304

Phase 3 Completed 1198 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupTriple-blindTreatment

Summary

This study will assess the effect of reversal of neuromuscular blockade with sugammadex compared with reversal according to usual care (neostigmine or spontaneous reversal) on the incidence of post-surgical bleeding events and on coagulation parameters in participants undergoing hip fracture surgery or joint (hip/knee) replacement surgery with neuromuscular blockage induced by rocuronium or vecuronium.

Timeline

Start
2011-10-12
Primary completion
2012-09-26
Completion
2012-09-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Neostigmine Other / unclassified Intravenous
Subject Sugammadex Other / unclassified 4 mg/kg Intravenous
Background Atropine Other / unclassified Intravenous
Background Glycopyrrolate Small molecule Intravenous