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NCT05723406
The Immunomodulatory Effect of Sugammadex After Total Hip Replacement Surgery Under Neuraxial Anaesthesia: a Pilot Study
Conditions: Innate Inflammatory Response, Osteoarthritis, Hip
Sex: All
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 20
Sponsor: Radboud University Medical Center
Location: Netherlands
Summary
Monocenter randomized controlled proof of principle study to investigate the effect of sugammadex at the end of total hip replacement surgery on the postoperative innate immune function
Eligibility Criteria
Inclusion Criteria:Age of 18 years or olderScheduled for total hip replacement surgery under neuraxial anesthesiaScheduled for primary hip replacement surgeryInformed consent obtainedExclusion Criteria:Insufficient control of the Dutch language to read the patient information and to fill out the questionnairesMentally incapacitated patientsKnown or suspected hypersensitivity to sugammadexDeficiency of vitamin K dependent clotting factors or coagulopathySevere renal disease (creatinine clearance <30 ml/min), including patients on dialysis)Severe liver disease (Child-Pugh Classification C)Women who are or may be pregnant or currently breastfeedingWomen of childbearing potential who don't use adequate method of contraceptionSevere vertebral column disorderChronic use of psychotropic drugsKnown hypertrophic obstructive cardiomyopathy, severe aortic valve stenosis or severe mitral valve stenosisChronic use of NSAID's, steroids or immunosuppressive drugs
Source: ClinicalTrials.gov (NCT05723406). StuddyBuddy aggregates publicly available trial information.