Innate Inflammatory ResponsePhase 2MAGICNCT05723406
The Immunomodulatory Effect of Sugammadex After Total Hip Replacement Surgery Under Neuraxial Anaesthesia: a Pilot Study
A Phase 2 study testing Sugammadex 100 MG/ML [Bridion] in people with Innate Inflammatory Response and Osteoarthritis, Hip, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Innate Inflammatory Response, Osteoarthritis, Hip
- What is being tested?
- Sugammadex 100 MG/ML [Bridion]
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Mar 2023to 23 Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 years or older
- Scheduled for total hip replacement surgery under neuraxial anesthesia
- Scheduled for primary hip replacement surgery
- Informed consent obtained
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- Sugammadex 100 MG/ML [Bridion], Placebo
- Medical subject headings
- Inflammation, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugammadex 100 MG/ML [Bridion]Drug
Also called Bridion
8 mg/ml
PlaceboOther
Sodium 0.9% 5 ml
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex | Experimental | Sugammadex administration at the end of surgery Receives: Drug: Sugammadex 100 MG/ML [Bridion] |
| Placebo | Placebo comparator | Placebo administration at the end of surgery Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Postoperative day 1
Secondary outcomes (7)
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
Measured: 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
Circulating inflammatory cytokines (TNF-α, IL-6, IL-10)
Measured: 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
Danger associated molecular pattern (DAMP) release (Heat shock protein 70 (HSP 70), High mobility group box 1 (HMGB1))
Measured: 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
Pain scores by numeric rating scale (NRS 0-10)
Measured: During hospital admission up to 3 days postoperative
Quality of Recovery
Quality of Recovery 40 (QoR-40) validated questionnaire score. 40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)
Measured: Postoperative day 1
Postoperative complications
postoperative complications scored by Clavien-Dindo classification; grade 0 (no deviation from ideal) grade 5 (death of patient)
Measured: Postoperative day 30
Postoperative infectious complications
Postoperative infectious complications scored the definitions of the StEP-COMPAC group initiative
Measured: Postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start21 Mar 2023
- Primary completion23 Nov 2023
- Study completion23 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Innate Inflammatory ResponseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723406
- Sponsor's protocol ID
- NL82808.091.22
- Acronym
- MAGIC
- Status last verified
- Jan 2023
- First submitted
- 27 Jan 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be analyzed for publication. After that it belongs to Radboud umc where other researchers of Radboud umc may or may not include this database to their study. But there will be no active sharing
Publications
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.
PubMed 39957489Jacobs 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.
PubMed 39773137
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immunomodulatory Effect of Sugammadex After Total Hip Replacement Surgery Under Neuraxial Anaesthesia: a Pilot Study
- ClinicalTrials.gov ID
- NCT05723406
- Acronym / sponsor ID
- MAGIC / NL82808.091.22
- Conditions
- Innate Inflammatory Response, Osteoarthritis, Hip
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- 23 Nov 2023 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex | Experimental | Drug: Sugammadex 100 MG/ML [Bridion]Sugammadex administration at the end of surgery |
| Placebo | Placebo comparator | Other: PlaceboPlacebo administration at the end of surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of 18 years or older
- Scheduled for total hip replacement surgery under neuraxial anesthesia
- Scheduled for primary hip replacement surgery
- Informed consent obtained
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugammadex 100 MG/ML [Bridion]Also: Bridion8 mg/ml | Drug | Sugammadex |
| PlaceboSodium 0.9% 5 ml | Other | Placebo |
Primary outcome
Postoperative innate immune function
Time frame: Postoperative day 1
Ex vivo cytokine production capacity (TNF-α, IL-6, IL-10, IL-1β) of mononuclear cells upon whole blood Lipopolysaccharide(LPS) stimulation
7 secondary outcomes
Postoperative innate immune function
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: During hospital admission up to 3 days postoperative
Quality of Recovery
Time frame: Postoperative day 1
Postoperative complications
Time frame: Postoperative day 30
Postoperative infectious complications
Time frame: Postoperative day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 39957489Bijkerk 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.
- Derived from this study: PubMed 39773137Jacobs 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.
- Individual participant dataSharing planned: No. All data will be analyzed for publication. After that it belongs to Radboud umc where other researchers of Radboud umc may or may not include this database to their study. But there will be no active sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sugammadex 100 MG/ML [Bridion] in people with Innate Inflammatory Response and Osteoarthritis, Hip, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative innate immune function (time frame: Postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05723406, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.