Conditions: Neuromuscular Blockade Arthroplasty, Replacement, Hip Arthroplasty, Replacement, Knee Blood Coagulation Antithrombotic Agents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1198
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Prior to randomization, participants will be assigned to planned active reversal or planned spontaneous recovery by the anesthesiologist according to the recovery method the anesthesiologist would have chosen if the participant were not in the study. In this treatment arm, participants assigned to planned active reversal will receive sugammadex and placebo to neostigmine, and participants assigned to planned spontaneous recovery will receive sugammadex. Study drug will be administered after the last dose of rocuronium or vecuronium and after wound closure. arm 2: Prior to randomization, participants will be assigned to planned active reversal or planned spontaneous recovery by the anesthesiologist according to the recovery method the anesthesiologist would have chosen if the participant were not in the study. In this treatment arm, participants assigned to planned active reversal will receive neostigmine and placebo to sugammadex, and participants assigned to planned spontaneous recovery will receive placebo to sugammadex. Study drug will be administered after the last dose of rocuronium or vecuronium and after wound closure.

Interventions: intervention 1: Sugammadex intervention 2: neostigmine and glycopyrrolate or atropine intervention 3: Placebo to neostigmine intervention 4: Placebo to sugammadex
Intervention descriptions: intervention 1: Sugammadex 4 mg/kg intravenously intervention 2: Neostigmine and glycopyrrolate or neostigmine and atropine administered intravenously per usual practice and per the product labels intervention 3: Normal saline (NaCl 0.9%) intervention 4: Normal saline (NaCl 0.9%)

Protocol document: