Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038)
Condition: Neuromuscular Blockade; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Blood Coagulation; Antithrombotic Agents
MeSH terms: Hip Fractures
Intervention: Sugammadex; neostigmine and glycopyrrolate or atropine; Placebo to neostigmine; Placebo to sugammadex
Intervention description: Sugammadex 4 mg/kg intravenously; Neostigmine and glycopyrrolate or neostigmine and atropine administered intravenously per usual practice and per the product labels; Normal saline (NaCl 0.9%); Normal saline (NaCl 0.9%)
Intervention MeSH terms: Atropine; Glycopyrrolate; Neostigmine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1198.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be American Society of Anesthesiologists (ASA) Class 1, 2, or 3

          -  Must be scheduled for a hip fracture surgery or joint (hip or knee) replacement
             surgery under general anesthesia including the use of rocuronium or vecuronium for
             neuromuscular blockade

          -  Must be:

               -  Currently receiving thromboprophylactic (anti-clotting) therapy with low
                  molecular weight heparin (LMWH) or unfractionated heparin (UFH), or

               -  Planned to initiate thromboprophylactic therapy with LMWH or UFH prior to or
                  during surgery, or

               -  Currently receiving ongoing thromboprophylactic therapy with a vitamin K
                  antagonist that has been temporarily substituted with peri-operative LMWH or UFH,
                  and/or

               -  Currently receiving ongoing thromboprophylactic therapy with low-dose aspirin or
                  other antiplatelet therapy

          -  Platelet count above the lower limit of normal range

          -  Appropriate candidate for rapid reversal of neuromuscular blockade

          -  Sexually active females must agree to use a medically accepted method of contraception
             through seven days after receiving protocol-specified medication

        Exclusion Criteria:

          -  Anatomical malformations that may lead to difficult intubation

          -  Neuromuscular disorder that may affect neuromuscular blockade

          -  History of a coagulation disorder, bleeding diathesis, systemic lupus erythematosus or
             antiphospholipid syndrome

          -  History or evidence of active abnormal bleeding or blood clotting within 30 days prior
             to screening

          -  Significant hepatic dysfunction

          -  Severe renal insufficiency

          -  History or family history of malignant hyperthermia

          -  Hypersensitivity or hypersensitivity-like reaction to sugammadex, muscle relaxants, or
             other medications used during general anesthesia

          -  Planned intravenous administration of toremifene and/or fusidic acid within 24 hours
             before or within 24 hours after study medication

          -  Recent, severe trauma

          -  Body Mass Index (BMI) > 35

          -  Any contraindication to administration of sugammadex or neostigmine/glycopyrrolate (or
             neostigmine/atropine)

          -  Pregnant or intends to become pregnant between randomization and the Day 30 follow-up
             visit

          -  Breast-feeding

          -  Previously treated with sugammadex or participated in a sugammadex clinical trial

          -  Has an active hip/knee infection and is scheduled for revision surgery