Monocyte Subsets Altered by Anesthesia

• Sponsor: University Hospital, Saarland (Other)
• Overall Status: Completed
• CT.gov ID: NCT03431532
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Actual Duration (Months): 24.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Regional Anesthesia; General Anesthesia; Immune Function

Detailed 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).

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Neuraxial Versus General Anesthesia for Total Knee Replacement Surgery - Are There Different Effects on the Immune System?
• Actual Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. CD 14 and HLA-DR Expression Patterns on monocytes [1 year]

   CD 14 and HLA-DR Expression Patterns on monocytes in whole blood culture assay

Secondary Outcome Measures

1. Intracellular TNF-alpha production [1 year]

   Intracellular TNF-alpha production in whole blood culture assay

2. TNF-alpha and IL-10 release [1 year]

   TNF-alpha and IL-10 release in whole blood culture assay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sven O. Schneider, MD	Homburg	Saarland	Germany	66424

Sponsors and Collaborators

• University Hospital, Saarland

Investigators

• Principal Investigator: Sven Schneider, MD, Universität des Saarlandes

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: University Hospital, Saarland
• ClinicalTrials.gov Identifier: NCT03431532
• Other Study ID Numbers: NA vs GA Immunology
• First Posted: Feb 13, 2018
• Last Update Posted: May 11, 2022
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Saarland: anesthesia; general anesthesia; neuraxial anesthesia; monocyte funtion; CD 14, HLA-DR; Interleukines

Study Results

No Results Posted as of May 11, 2022