Phase 3
Completed N=1,198
Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038)
Neuromuscular Blockade · Arthroplasty, Replacement, Hip · Arthroplasty, Replacement, Knee · Blood Coagulation
Source: ClinicalTrials.gov NCT01422304 ↗
Enrolled (actual)
1,198
Serious AEs
6.7%
Results posted
Oct 2013
Primary outcomePrimary: Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 24 Hours After Study Drug Administration — 17; 24 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 24 Hours After Study Drug Administration |
17; 24 | — |
| SECONDARY Percent Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at 10 and 60 Minutes Post Study Drug Administration |
6.0; -0.1; 0.4; -1.2 | — |
| SECONDARY Percent Change From Baseline in Prothrombin Time (International Normalized Ratio) (PT[INR]) at 10 and 60 Minutes Post Study Drug Administration |
8.0; 2.5; 8.9; 3.4 | — |
| SECONDARY Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 14 Days After Study Drug Administration |
24; 27 | — |
| SECONDARY Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 24 Hours After Study Drug Administration |
12; 20 | — |
| SECONDARY Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 14 Days After Study Drug Administration |
18; 23 | — |
| SECONDARY Number of Participants With One or More Adjudicated Venous Thromboembolic (VTE) Events With Onset Within 14 Days After Study Drug Administration |
5; 3 | — |
| SECONDARY Number of Participants With One or More Adjudicated Events of Anaphylaxis With Onset Within 14 Days After Study Drug Administration |
0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT01422304). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.