The Immunomodulatory Effect of Sugammadex After Total Hip Replacement Surgery Under Neuraxial Anaesthesia: a Pilot Study

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University Medical Center

Criteria

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