Regional AnesthesiaNCT03431532
Monocyte Subsets Altered by Anesthesia
An observational study of Regional Anesthesia and General Anesthesia, run by University Hospital, Saarland at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Regional Anesthesia, General Anesthesia, Immune Function
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2013to 1 Mar 2015
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Surgical patients ungergoing total knee replacement surgery in neuraxial or General aneshtesia
Who may be able to join
- Total knee replacement surgery
- 18 years or older
Who cannot join
- clinical signs of infection,
- neoplasia
- treatment with immunomodulatory agents
- any kind of immune mediated disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuraxial Versus General Anesthesia for Total Knee Replacement Surgery - Are There Different Effects on the Immune System?
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).
Read the 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).
- Conditions
- Regional Anesthesia, General Anesthesia, Immune Function
- Keywords
- anesthesia, general anesthesia, neuraxial anesthesia, monocyte funtion, CD 14, HLA-DR, Interleukines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD 14 and HLA-DR Expression Patterns on monocytes
CD 14 and HLA-DR Expression Patterns on monocytes in whole blood culture assay
Measured: 1 year
Secondary outcomes (2)
Intracellular TNF-alpha production
Intracellular TNF-alpha production in whole blood culture assay
Measured: 1 year
TNF-alpha and IL-10 release
TNF-alpha and IL-10 release in whole blood culture assay
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Feb 2013
- Primary completion1 Jan 2015
- Study completion1 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Regional AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sven Schneider, MD, Principal investigator, Universität des Saarlandes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431532
- Sponsor's protocol ID
- NA vs GA Immunology
- Status last verified
- Feb 2018
- First submitted
- 30 Jan 2018
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29094483Schneider 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.
PubMed 25294235Schneider 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.
PubMed 22571497Schneider 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.
PubMed 19630915Biedler 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.
PubMed 12411792
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuraxial Versus General Anesthesia for Total Knee Replacement Surgery - Are There Different Effects on the Immune System?
- ClinicalTrials.gov ID
- NCT03431532
- Acronym / sponsor ID
- NA vs GA Immunology
- Conditions
- Regional Anesthesia, General Anesthesia, Immune Function
- Keywords
- anesthesia, general anesthesia, neuraxial anesthesia, monocyte funtion, CD 14, HLA-DR, Interleukines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 1 Jan 2015 (actual)
- Study completion
- 1 Mar 2015 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical patients ungergoing total knee replacement surgery in neuraxial or General aneshtesia
Key inclusion criteria (2 listed)
- Total knee replacement surgery
- 18 years or older
Key exclusion criteria (4 listed)
- clinical signs of infection,
- neoplasia
- treatment with immunomodulatory agents
- any kind of immune mediated disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Intracellular TNF-alpha production
Time frame: 1 year
TNF-alpha and IL-10 release
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Background: PubMed 29094483Bomberg 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.
- Background: PubMed 25294235Schneider 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.
- Background: PubMed 22571497Schneider 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.
- Background: PubMed 19630915Schneider 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.
- Background: PubMed 12411792Biedler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Schneider, MD principal investigator
Universität des Saarlandes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Regional Anesthesia and General Anesthesia, run by University Hospital, Saarland at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD 14 and HLA-DR Expression Patterns on monocytes (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03431532, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.