NCT01422304

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

A Randomized, Controlled, Parallel-group, Double-blind Trial of Sugammadex or Usual Care (Neostigmine or Spontaneous Recovery) for Reversal of Rocuronium- or Vecuronium-induced Neuromuscular Blockade in Patients Receiving Thromboprophylaxis and Undergoing Hip Fracture Surgery or Joint (Hip/Knee) Replacement (Protocol No. P07038)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,198 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will be randomized to sugammadex or usual care in a 1:1 ratio.

Conditions

• Neuromuscular Blockade
• Arthroplasty, Replacement, Hip
• Arthroplasty, Replacement, Knee
• Blood Coagulation
• Antithrombotic Agents

Interventions

Type	Name	Description
DRUG	Sugammadex	Sugammadex 4 mg/kg intravenously
DRUG	neostigmine and glycopyrrolate or atropine	Neostigmine and glycopyrrolate or neostigmine and atropine administered intravenously per usual practice and per the product labels
DRUG	Placebo to neostigmine	Normal saline (NaCl 0.9%)
DRUG	Placebo to sugammadex	Normal saline (NaCl 0.9%)

Timeline

• Start date: 2011-10-12
• Primary completion: 2012-09-26
• Completion: 2012-09-26
• First posted: 2011-08-23
• Last updated: 2021-02-12
• Results posted: 2013-10-30