NCT05723406

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Innate Inflammatory Response
• Osteoarthritis, Hip

Interventions

Type	Name	Description
DRUG	Sugammadex 100 MG/ML [Bridion]	8 mg/ml
OTHER	Placebo	Sodium 0.9% 5 ml

Timeline

• Start date: 2023-03-21
• Primary completion: 2023-11-23
• Completion: 2023-11-23
• First posted: 2023-02-10
• Last updated: 2023-11-28

Locations

1 site across 1 country: Netherlands