The Immunomodulatory Effect of Sugammadex After Total Hip Replacement Surgery Under Neuraxial Ana… (NCT05723406) | Clinical Trial Compass
CompletedPhase 2
The Immunomodulatory Effect of Sugammadex After Total Hip Replacement Surgery Under Neuraxial Anaesthesia: a Pilot Study
Netherlands20 participantsStarted 2023-03-21
Plain-language 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
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age of 18 years or older
* Scheduled for total hip replacement surgery under neuraxial anesthesia
* Scheduled for primary hip replacement surgery
* Informed consent obtained
Exclusion Criteria:
* Insufficient control of the Dutch language to read the patient information and to fill out the questionnaires
* Mentally incapacitated patients
* Known or suspected hypersensitivity to sugammadex
* Deficiency of vitamin K dependent clotting factors or coagulopathy
* Severe 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 breastfeeding
* Women of childbearing potential who don't use adequate method of contraception
* Severe vertebral column disorder
* Chronic use of psychotropic drugs
* Known hypertrophic obstructive cardiomyopathy, severe aortic valve stenosis or severe mitral valve stenosis
* Chronic use of NSAID's, steroids or immunosuppressive drugs