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Completed

NCT Number: NCT03431532

Monocyte Subsets Altered by Anesthesia

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).

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Key information

Conditions

Regional Anesthesia General Anesthesia Immune Function

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Sven O. Schneider, MD

Homburg, Saarland, 66424, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 1 year

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

Secondary outcomes

  1. Intracellular TNF-alpha production

    Time frame: 1 year

    Intracellular TNF-alpha production in whole blood culture assay

  2. TNF-alpha and IL-10 release

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

University Hospital, Saarland

Other

Registry information

Official study title

Neuraxial Versus General Anesthesia for Total Knee Replacement Surgery - Are There Different Effects on the Immune System?

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 13, 2018
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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