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

Radboud University Medical Center

Status and phase

Completed

Phase 2

Conditions

Osteoarthritis, Hip

Innate Inflammatory Response

Treatments

Other: Placebo

Drug: Sugammadex 100 MG/ML [Bridion]

Study type

Interventional

Funder types

Other

Identifiers

NCT05723406

NL82808.091.22

Details and patient eligibility

About

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

Full description

Rationale: With infections being the number one complication after surgery, more research is aimed at therapeutic strategies that positively influence the postoperative immune dysregulation. In the search for reducing surgical stress by a deep neuromuscular block (NMB), our group recently found evidence that sugammadex, used to antagonize a deep NMB, may have an immunomodulatory effect. Ex vivo analysis showed that sugammadex counteracted the immunosuppressive effect of rocuronium, but even in absence of rocuronium it had a positive effect on cytokine production capacity.

Therefore, we now propose a clinical pilot study in patients planned for total hip surgery under neuraxial anaesthesia to further investigate whether sugammadex has beneficial immunomodulatory effects.

Primary objective: To investigate the effect of sugammadex on the postoperative innate immune function.

Study design: A blinded, randomized controlled pilot study

Study population: 20 adults scheduled for primary hip replacement surgery under neuraxial anaesthesia.

Intervention: Patients will be randomized between a group receiving sugammadex at the end of surgery and a group receiving placebo.

Primary endpoint: Postoperative innate immune function as reflected by ex vivo mononuclear cell cytokine production capacity upon whole blood lipopolysaccharide (LPS) stimulation.

Secondary endpoint: Postoperative innate immune function as reflected by DAMP release and circulating inflammatory cytokines, Quality of Recovery score (QoR-40) postoperative day 1, postoperative pain and analgesia consumption, 30-day postoperative (infectious) complications

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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