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

NCT ID: NCT05723406

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-21

Study Completion Date

2023-11-23

Brief Summary

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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

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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

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Innate Inflammatory Response Osteoarthritis, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Sugammadex

Sugammadex administration at the end of surgery

Group Type EXPERIMENTAL

Sugammadex 100 MG/ML [Bridion]

Intervention Type DRUG

8 mg/ml

Placebo

Placebo administration at the end of surgery

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Sodium 0.9% 5 ml

Interventions

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Sugammadex 100 MG/ML [Bridion]

8 mg/ml

Intervention Type DRUG

Placebo

Sodium 0.9% 5 ml

Intervention Type OTHER

Other Intervention Names

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Bridion

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Radboudumc

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

References

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Bijkerk V, Jacobs LMC, Visser J, van Helden EV, Keijzer C, Helder LS, Albers KI, Warle MC. The immunomodulatory effect of sugammadex in vitro and after total hip arthroplasty : A randomised controlled pilot and retrospective cohort study. Eur J Anaesthesiol. 2025 Aug 1;42(8):676-686. doi: 10.1097/EJA.0000000000002132. Epub 2025 Feb 14.

Reference Type DERIVED
PMID: 39957489 (View on PubMed)

Jacobs LMC, Bijkerk V, van Eijk LT, Joosten LAB, Keijzer C, Visser J, Warle MC. The effect of general versus spinal anesthesia on perioperative innate immune function in patients undergoing total hip arthroplasty. BMC Anesthesiol. 2025 Jan 7;25(1):10. doi: 10.1186/s12871-024-02883-1.

Reference Type DERIVED
PMID: 39773137 (View on PubMed)

Other Identifiers

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NL82808.091.22

Identifier Type: -

Identifier Source: org_study_id