NCT03431532

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
Last Updated

May 11, 2022

Status Verified

February 1, 2018

Enrollment Period

1.9 years

First QC Date

January 30, 2018

Last Update Submit

May 10, 2022

Conditions

Regional AnesthesiaGeneral AnesthesiaImmune Function

Keywords

anesthesiageneral anesthesianeuraxial anesthesiamonocyte funtionCD 14, HLA-DRInterleukines

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Intracellular TNF-alpha production

    1 year

  • TNF-alpha and IL-10 release

    1 year

Study Arms (2)

neuraxial anesthesia

Patients with total knee replacement surgery having neuraxial anesthesia along with the procedure.

general anesthesia

Patients with total knee replacement surgery having General anesthesia along with the procedure.

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Surgical patients ungergoing total knee replacement surgery in neuraxial or General aneshtesia

You may qualify if:

  • Total knee replacement surgery
  • years or older

You may not qualify if:

  • clinical signs of infection,
  • neoplasia
  • treatment with immunomodulatory agents
  • any kind of immune mediated disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sven O. Schneider, MD

Homburg, Saarland, 66424, Germany

Location

Related Publications (5)

  • Bomberg H, Volk T, Biedler A, Schneider SO. Impact of intraoperative blood salvage on monocyte subsets alteration and intracellular tumor necrosis factor-alpha production. J Biomed Mater Res A. 2018 Mar;106(3):815-821. doi: 10.1002/jbm.a.36281. Epub 2017 Nov 28.

    PMID: 29094483BACKGROUND

  • 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.

    PMID: 25294235BACKGROUND

  • 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.

    PMID: 22571497BACKGROUND

  • Schneider SO, Rensing H, Graber S, Kreuer S, Kleinschmidt S, Kreimeier S, Muller 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.

    PMID: 19630915BACKGROUND

  • 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. doi: 10.1097/00000542-200211000-00011.

    PMID: 12411792BACKGROUND

Study Officials

  • Sven Schneider, MD

    Universität des Saarlandes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2018

First Posted

February 13, 2018

Study Start

February 1, 2013

Primary Completion

January 1, 2015

Study Completion

March 1, 2015

Last Updated

May 11, 2022

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)