The effect of sugammadex on the postoperative immune function after total hip replacement under neuraxial anesthesia

The immunomodulatory effect of sugammadex after total hip replacement surgery under neuraxial anaesthesia: a pilot study - MAGIC study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-003325-22-NL

Enrollment

Registered

2022-11-07

Start date

2023-01-25

Completion date

Unknown

Last updated

2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip osteoarthritis

Interventions

Trade Name: Sugammadex Product Name: Sugammadex Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intraveno

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age of 18 years or older - Scheduled for total hip replacement surgery under neuraxial surgery - Scheduled for primary hip replacement surgery - Informed consent obtained Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - Insufficient control of the Dutch language to read the patient information and to fill out de questionnaires - 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 - Severe vertebral column disorder - Chronic use of psychotropic drugs - Known hypertrophic obstructive cardiomyopathy, severe aortic valve stenosis or severe mitral valve stenosis - Use of immunomodulatory medication

Design outcomes

Primary

Measure	Time frame
Main Objective: The overall objective of this study is to investigate the potential immunomodulatory effect of sugammadex as seen in previous ex vivo experiments. Specified, the main objective is to investigate the effect of administration of sugammadex without prior neuromuscular blockade on postoperative innate immune function as reflected by cytokine production capacity of mononuclear cells.;Secondary Objective: To investigate the effect of administration of sugammadex without prior neuromuscular blockade on: - Postoperative innate immune function as reflected by DAMP release - Systemic inflammation as reflected by circulating inflammatory cytokines - Postoperative pain scores and analgesia consumption - Postoperative quality of recovery - Postoperative (infectious) complications ;Primary end point(s): Innate immune function as reflected by - Ex vivo cytokine (TNF-a, IL-6, IL-10, IL-1ß) production capacity of mononuclear cells upon whole blood lipopolysaccharide (LPS) stimulation. ;Timepoint(s) of evaluation of this end point: End of surgery Postoperative day 1	—

Measure

Time frame

Main Objective: The overall objective of this study is to investigate the potential immunomodulatory effect of sugammadex as seen in previous ex vivo experiments. Specified, the main objective is to investigate the effect of administration of sugammadex without prior neuromuscular blockade on postoperative innate immune function as reflected by cytokine production capacity of mononuclear cells.;Secondary Objective: To investigate the effect of administration of sugammadex without prior neuromuscular blockade on: - Postoperative innate immune function as reflected by DAMP release - Systemic inflammation as reflected by circulating inflammatory cytokines - Postoperative pain scores and analgesia consumption - Postoperative quality of recovery - Postoperative (infectious) complications ;Primary end point(s): Innate immune function as reflected by - Ex vivo cytokine (TNF-a, IL-6, IL-10, IL-1ß) production capacity of mononuclear cells upon whole blood lipopolysaccharide (LPS) stimulation. ;Timepoint(s) of evaluation of this end point: End of surgery Postoperative day 1

—

Secondary

Measure	Time frame
Secondary end point(s): - Innate immune function at the end of surgery and postoperative day 1 as reflected by - Circulating inflammatory cytokines (TNF-a, IL-6, IL-10) - DAMP release (HSP70, HMGB1) - Pain scores (NRS 0-10) and total analgesia consumption at the post anesthesia care unit (PACU) and postoperative day 1. - Quality of Recovery score (QoR-40) at postoperative day 1(11). - 30-day postoperative infectious complications scored according to the relevant endpoint of the StEP-COMPAC group initiative - 30-day postoperative complications scored by Clavien Dindo classification. ;Timepoint(s) of evaluation of this end point: End of surgery Post anesthesia care unit Postoperative day 1 Postoperative day 30	—

Measure

Time frame

Secondary end point(s): - Innate immune function at the end of surgery and postoperative day 1 as reflected by - Circulating inflammatory cytokines (TNF-a, IL-6, IL-10) - DAMP release (HSP70, HMGB1) - Pain scores (NRS 0-10) and total analgesia consumption at the post anesthesia care unit (PACU) and postoperative day 1. - Quality of Recovery score (QoR-40) at postoperative day 1(11). - 30-day postoperative infectious complications scored according to the relevant endpoint of the StEP-COMPAC group initiative - 30-day postoperative complications scored by Clavien Dindo classification. ;Timepoint(s) of evaluation of this end point: End of surgery Post anesthesia care unit Postoperative day 1 Postoperative day 30

—

Countries

Netherlands

Contacts

Public ContactVascular surgery

Radboudumc

veerle.bijkerk@radboudumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026