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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03431532
Other study ID # NA vs GA Immunology
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2013
Est. completion date March 1, 2015

Study information

Verified date February 2018
Source Universität des Saarlandes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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).


Description:

Numerous of factors affect the immunological response during surgery. Despite intensive research, 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). Samples of venous blood were taken from the patients before and after induction of anesthesia, immediately, 6 hours, 24 hours, and 48 hours after surgery. All blood samples were incubated in presence or absence of LPS (lipopolysaccharide; 1 µg/ml) for 24 hours. 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).


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Sven O. Schneider, MD Homburg Saarland

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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

Outcome

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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