General Anesthesia Clinical Trial
Official title:
Neuraxial Versus General Anesthesia for Total Knee Replacement Surgery - Are There Different Effects on the Immune System?
Verified date | February 2018 |
Source | Universität des Saarlandes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The impact of different anesthetic techniques on the immune system remains unclear. Aim of this ex vivo / in vitro study was to determine the effects of general and neuraxial anesthesia on monocyte subset alteration and the release of prototypical pro- and anti-inflammatory cytokines. Twenty patients undergoing total knee replacement surgery were randomly assigned to receive either general anesthesia (ITN) or combined spinal/epidural anesthesia (CSE). CD14 and HLA-DR expression patterns on monocytes and intracellular TNF-alpha production were quantified via flow cytometry. TNF-α and IL-10 release were measured via enzyme linked immunosorbent assay (ELISA).
Status | Completed |
Enrollment | 20 |
Est. completion date | March 1, 2015 |
Est. primary completion date | January 1, 2015 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Total knee replacement surgery - 18 years or older Exclusion Criteria: - clinical signs of infection, - neoplasia - treatment with immunomodulatory agents - any kind of immune mediated disease. |
Country | Name | City | State |
---|---|---|---|
Germany | Sven O. Schneider, MD | Homburg | Saarland |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Saarland |
Germany,
Biedler AE, Schneider SO, Seyfert U, Rensing H, Grenner S, Girndt M, Bauer I, Bauer M. Impact of alloantigens and storage-associated factors on stimulated cytokine response in an in vitro model of blood transfusion. Anesthesiology. 2002 Nov;97(5):1102-9. — View Citation
Bomberg H, Volk T, Biedler A, Schneider SO. Impact of intraoperative blood salvage on monocyte subsets alteration and intracellular tumor necrosis factor-a production. J Biomed Mater Res A. 2018 Mar;106(3):815-821. doi: 10.1002/jbm.a.36281. Epub 2017 Nov 28. — View Citation
Schneider SO, Biedler AE, Behmenburg F, Volk T, Rensing H. Impact of shed blood products on stimulated cytokine release in an in vitro model of transfusion. Acta Anaesthesiol Scand. 2012 Jul;56(6):724-9. doi: 10.1111/j.1399-6576.2012.02704.x. Epub 2012 May 9. — View Citation
Schneider SO, Rensing H, Gräber S, Kreuer S, Kleinschmidt S, Kreimeier S, Müller P, Mathes AM, Biedler AE. Impact of platelets and fresh frozen plasma in contrast to red cell concentrate on unstimulated and stimulated cytokine release in an in vitro model of transfusion. Scand J Immunol. 2009 Aug;70(2):101-5. doi: 10.1111/j.1365-3083.2009.02278.x. — View Citation
Schneider SO, Rensing H, Hartmann L, Grundmann U, Volk T, Biedler A. Impact of intraoperatively salvaged and washed blood on stimulated cytokine release in vitro. Transfusion. 2014 Oct;54(10 Pt 2):2782-90. doi: 10.1111/trf.12781. Epub 2014 Oct 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CD 14 and HLA-DR Expression Patterns on monocytes | CD 14 and HLA-DR Expression Patterns on monocytes in whole blood culture assay | 1 year | |
Secondary | Intracellular TNF-alpha production | Intracellular TNF-alpha production in whole blood culture assay | 1 year | |
Secondary | TNF-alpha and IL-10 release | TNF-alpha and IL-10 release in whole blood culture assay | 1 year |
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