Trial reportEuropean journal of anaesthesiology2025
The immunomodulatory effect of sugammadex in vitro and after total hip arthroplasty : A randomised controlled pilot and retrospective cohort study.
Trial report in European journal of anaesthesiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Early Postoperative Pain and 30-day Complications Following Major Abdominal Surgery: an Observational Study
The Immunomodulatory Effect of Sugammadex After Total Hip Replacement Surgery Under Neuraxial Anaesthesia: a Pilot Study
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPostoperative immunosuppression is a well known phenomenon associated with infectious complications. Peri-operative immune dysregulation is likely induced by surgical damage and anaesthetics, but remains far from comprehensively characterised. To address this, the effects of individual drugs on immune function must be explored. Sugammadex, a cyclodextrin that encapsulates rocuronium, also binds other drugs and structures and may influence the inflammatory response.
objectiveInvestigate the potential immunomodulatory effect of sugammadex.
designAn in-vitro experiment, randomised controlled pilot study and retrospective cohort study.
settingTertiary teaching hospital. PATIENTS: Twelve healthy donors, 20 adults undergoing total hip arthroplasty and 1000 major abdominal surgery patients.
interventionIn vitro: isolated peripheral blood mononuclear cells were exposed to sugammadex and rocuronium before stimulation with Escherichia coli lipopolysaccharides (LPS).Pilot study: patients undergoing total hip arthroplasty under single shot spinal anaesthesia randomised to sugammadex (8 mg kg -1 ) or placebo at the end of surgery.
main outcome measureIn vitro: TNF, IL-1β and IL-6 production capacity.Pilot study: Ex-vivo cytokine production capacity after whole blood stimulation with LPS.Retrospective cohort: sugammadex as a predictor of postoperative infectious complications.
resultsIn vitro : rocuronium suppressed TNF and IL-1β production capacity. Higher doses of sugammadex (100 and 1000 μg ml -1 ; 100 μg ml -1 corresponds to plasma concentration reached upon 8 mg kg -1 sugammadex) restored suppression of TNF and IL-1β.Pilot study: no differences in ex-vivo cytokine production capacity between the sugammadex and placebo group at the end of surgery or on postoperative day 1.Retrospective cohort study : no association between sugammadex and postoperative infectious complications (OR = 1.000, 95% CI 0.998 to 1.002).
conclusionSugammadex preserved cytokine production capacity of TNF and IL-1β in vitro . The clinical pilot study and retrospective cohort study revealed no early postoperative immunomodulatory effects for sugammadex in the clinically used dosing range.
trial registrationclinicaltrials.gov identifier: NCT05723406 and NCT05244655.
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