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.

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. - P07038

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35664

Enrollment

Registered

2011-08-19

Start date

2011-09-12

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opheffing van neuromusculaire blokkade bij heupfractuuroperatie of gewrichtsvervanging Reversal of muscle relaxant

Interventions

- Treatment with either sugammadex, combination of neostigmine and atropine, or placebo - One follow-up visit 4-7 weeks after treatment

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients must be: aged >=*18 years; ASA (American Society of Anesthesiologists) Class 1, 2, or 3; scheduled for hip fracture surgery or joint (hip or knee) replacement surgery under general anesthesia including the use of rocuronium or vecuronium for neuromuscular blockade; and appropriate candidates for rapid reversal of neuromuscular blockade. At screening, patients must be: currently receiving ongoing thromboprophylactic therapy with low molecular weight heparins (LMWH) or unfractionated heparins (UFH); planned to initiate thromboprophylactic therapy with LMWH or UFH prior to or during surgery (ie, prior to administration of study medication); currently receiving thromboprophylactic therapy with a vitamin K antagonist which will be temporarily substituted with peri-operative LMWH or UFH; and/or currently receiving ongoing thromboprophylaxis with low-dose aspirin or other antiplatelet therapy (eg, clopidogrel, ticlopidine, dipyridamole). Platelet count must be above the lower limit of the normal range.

Exclusion criteria

Exclusion criteria: Patients with severe renal impairment (eg, creatinine clearance

Design outcomes

Primary

Measure	Time frame
The primary analysis will assess the proportion of patients with at least one adjudicated event of bleeding (major or non-major) with an onset within 24 hours after administration of study medication. This assessment will use the stratified Cochran-Mantel-Haenszel method, stratifying for thromboprophylactic therapy (including LMWH, including UFH, or not including either LMWH or UFH) and renal function (estimated creatinine clearance = 60 mL/min).	—

Measure

Time frame

The primary analysis will assess the proportion of patients with at least one adjudicated event of bleeding (major or non-major) with an onset within 24 hours after administration of study medication. This assessment will use the stratified Cochran-Mantel-Haenszel method, stratifying for thromboprophylactic therapy (including LMWH, including UFH, or not including either LMWH or UFH) and renal function (estimated creatinine clearance = 60 mL/min).

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Secondary

Measure	Time frame
The key secondary analysis will assess aPTT measured at 10 and 60 minutes after administration of study medication. aPTT values will be analyzed using constrained longitudinal data analysis, adjusting for the following factors: investigational center, thromboprophylactic therapy (including LMWH, including UFH, or not including either LMWH or UFH), renal function (estimated creatinine clearance = 60 mL/min), usual care (neostigmine or spontaneous recovery), and surgical procedure (hip fracture surgery, hip replacement, knee replacement).	—

Measure

Time frame

The key secondary analysis will assess aPTT measured at 10 and 60 minutes after administration of study medication. aPTT values will be analyzed using constrained longitudinal data analysis, adjusting for the following factors: investigational center, thromboprophylactic therapy (including LMWH, including UFH, or not including either LMWH or UFH), renal function (estimated creatinine clearance = 60 mL/min), usual care (neostigmine or spontaneous recovery), and surgical procedure (hip fracture surgery, hip replacement, knee replacement).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)