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

Primary Purpose

Innate Inflammatory Response, Osteoarthritis, Hip

Status
Recruiting
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Sugammadex 100 MG/ML [Bridion]
Placebo
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Innate Inflammatory Response

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • RadboudumcRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sugammadex

Placebo

Arm Description

Sugammadex administration at the end of surgery

Placebo administration at the end of surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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 innate immune function
Circulating inflammatory cytokines (TNF-α, IL-6, IL-10)
Postoperative innate immune function
Danger associated molecular pattern (DAMP) release (Heat shock protein 70 (HSP 70), High mobility group box 1 (HMGB1))
Pain and total analgesia consumption
Pain scores by numeric rating scale (NRS 0-10)
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)
Postoperative complications
postoperative complications scored by Clavien-Dindo classification; grade 0 (no deviation from ideal) grade 5 (death of patient)
Postoperative infectious complications
Postoperative infectious complications scored the definitions of the StEP-COMPAC group initiative

Full Information

First Posted
January 27, 2023
Last Updated
March 28, 2023
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05723406
Brief Title
The Immunomodulatory Effect of Sugammadex After Total Hip Replacement Surgery Under Neuraxial Anaesthesia: a Pilot Study
Acronym
MAGIC
Official Title
The Immunomodulatory Effect of Sugammadex After Total Hip Replacement Surgery Under Neuraxial Anaesthesia: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Innate Inflammatory Response, Osteoarthritis, Hip

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sugammadex
Arm Type
Experimental
Arm Description
Sugammadex administration at the end of surgery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administration at the end of surgery
Intervention Type
Drug
Intervention Name(s)
Sugammadex 100 MG/ML [Bridion]
Other Intervention Name(s)
Bridion
Intervention Description
8 mg/ml
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Sodium 0.9% 5 ml
Primary Outcome Measure Information:
Title
Postoperative innate immune function
Description
Ex vivo cytokine production capacity (TNF-α, IL-6, IL-10, IL-1β) of mononuclear cells upon whole blood Lipopolysaccharide(LPS) stimulation
Time Frame
Postoperative day 1
Secondary Outcome Measure Information:
Title
Postoperative innate immune function
Description
Ex vivo cytokine production capacity (TNF-α, IL-6, IL-10, IL-1β) of mononuclear cells upon whole blood Lipopolysaccharide(LPS) stimulation
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)
Title
Postoperative innate immune function
Description
Circulating inflammatory cytokines (TNF-α, IL-6, IL-10)
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)
Title
Postoperative innate immune function
Description
Danger associated molecular pattern (DAMP) release (Heat shock protein 70 (HSP 70), High mobility group box 1 (HMGB1))
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)
Title
Pain and total analgesia consumption
Description
Pain scores by numeric rating scale (NRS 0-10)
Time Frame
During hospital admission up to 3 days postoperative
Title
Quality of Recovery
Description
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)
Time Frame
Postoperative day 1
Title
Postoperative complications
Description
postoperative complications scored by Clavien-Dindo classification; grade 0 (no deviation from ideal) grade 5 (death of patient)
Time Frame
Postoperative day 30
Title
Postoperative infectious complications
Description
Postoperative infectious complications scored the definitions of the StEP-COMPAC group initiative
Time Frame
Postoperative day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Radboudumc
City
Nijmegen
ZIP/Postal Code
6500HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veerle Bijkerk, MD
Phone
0031 24 361 5333
First Name & Middle Initial & Last Name & Degree
Michiel C Warlé, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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

Learn more about this trial

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

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