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

NCT05723406 | Completed Phase 2

• 1 other identifier: NL82808.091.22
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Innate Inflammatory Response; Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (1)

• Postoperative innate immune function

  Ex vivo cytokine production capacity (TNF-α, IL-6, IL-10, IL-1β) of mononuclear cells upon whole blood Lipopolysaccharide(LPS) stimulation

  Postoperative day 1

Secondary Outcomes (7)

• Postoperative innate immune function

  2 timepoints: At the start of surgery (±30 minutes after administration neuraxial anesthesia) and at the end of surgery (15 minutes after administration intervention/placebo medication)

• Postoperative innate immune function

  3 timepoints: Postoperative day 1, at the start of surgery (±30 minutes after administration neuraxial anesthesia) and at the end of surgery (±15 minutes after administration intervention/placebo medication)

• Postoperative innate immune function

  3 timepoints: Postoperative day 1, at the start of surgery (±30 minutes after administration neuraxial anesthesia), and at the end of surgery (±15 minutes after administration intervention/placebo medication)

• Pain and total analgesia consumption

  During hospital admission up to 3 days postoperative

• Quality of Recovery

  Postoperative day 1

Study Arms (2)

Sugammadex

EXPERIMENTAL

Sugammadex administration at the end of surgery

Drug: Sugammadex 100 MG/ML [Bridion]

Placebo

PLACEBO COMPARATOR

Placebo administration at the end of surgery

Other: Placebo

Interventions

Sugammadex 100 MG/ML [Bridion] DRUG

8 mg/ml

Also known as: Bridion

Sugammadex

Placebo OTHER

Sodium 0.9% 5 ml

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 years or older
• Scheduled for total hip replacement surgery under neuraxial anesthesia
• Scheduled for primary hip replacement surgery
• Informed consent obtained

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, 6500HB, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 39957489 DERIVED

• 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.

  PMID: 39773137 DERIVED

MeSH Terms

Conditions

Inflammation; Osteoarthritis, Hip

Interventions

Sugammadex

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 10, 2023
• Study Start: March 21, 2023
• Primary Completion: November 23, 2023
• Study Completion: November 23, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)