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CompletedNCT06984315Updated May 25, 2025

Effects of Anesthesia Type on Inflammatory Response

An observational study in Spinal Aneshtesia, General Anesthetic and Inflammation, sponsored by Tokat Gaziosmanpasa University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-25.

Sponsored by Tokat Gaziosmanpasa University · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
849
Ages
18 Years to 75 Years
Sex
All
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Study summary

In total knee arthroplasty, surgical and anesthetic procedures can lead to a significant increase in systemic inflammation. This procedure is frequently performed under either general or spinal anesthesia. However, studies investigating the effect of anesthesia type on systemic inflammation have shown conflicting results. The Systemic Inflammatory Response Index (SIRI) and the Systemic Immune-Inflammation Index (SII) provide important information about the extent of systemic inflammation. This study aimed to investigate the effects of general and spinal anesthesia on perioperative changes in SII and SIRI during total knee arthroplasty. Between January 2020 and April 2025, data from 849 patients who underwent total knee arthroplasty were retrospectively reviewed. Patients received either spinal anesthesia (Group S) or general anesthesia (Group G). The groups were compared in terms of changes in perioperative SII and SIRI (ΔSII and ΔSIRI), total opioid consumption, postoperative complications, and length of hospital stay.

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Conditions studied

  • Spinal Aneshtesia
  • General Anesthetic
  • Inflammation
  • Neutrophils
  • Total Knee Arthroplasty
  • White Blood Cells

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In context

Inflammation

3,512 studies on the registry are indexed under Inflammation; 640 are open to participants now.

This study's enrollment of 849 is above the median of 95 across 913 observational studies indexed under Inflammation.

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Lead sponsor

Tokat Gaziosmanpasa University is the lead sponsor of 170 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Between January 2020 and April 2025, data from 849 patients who underwent total knee arthroplasty were retrospectively reviewed.

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Inclusion criteria

  • Patients aged 18 to 75 years
  • Patients with ASA physical status I or II
  • Patients who have underwent total knee arthroplasty under general or spinal anesthesia

Exclusion criteria

Exclusion Criteria:

  • Patients with BMI ≥40 kg/m2
  • Patients with ASA physical status ≥III
  • Patients with severe cardiopulmonary or metabolic disorders, coagulation disorders or active infection
  • Patients with known allergies or chronic steroid use
  • Patients with incomplete laboratory data
  • Patients who underwent revision total knee arthroplasty
  • Patients who required intraoperative conversion from spinal to general anesthesia
  • Patients with a history of major trauma and/or emergency surgery
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
849 participants (actual)
Patient registry
No

Groups and cohorts

  • Group S

    Underwent total knee arthroplasty under spinal anesthesia

    Other: The effects of the groups on perioperative inflammation changes were compared.

  • Group G

    Underwent total knee arthroplasty under general anesthesia

    Other: The effects of the groups on perioperative inflammation changes were compared.

Interventions

  • OtherThe effects of the groups on perioperative inflammation changes were compared.

    Between January 2020 and April 2025, data from 849 patients who underwent total knee arthroplasty were retrospectively reviewed. Preoperative hemogram values were obtained during routine anesthesia clinic evaluation, typically one day prior to surgery. Postoperative hemogram samples were collected on the day of surgery (postoperative day 0), within 4 to 12 hours after the procedure. Blood parameters included neutrophil, lymphocyte, monocyte, and platelet counts. Based on these values, inflammatory indices such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), systemic immune-inflammation index (SII), and systemic inflammatory response index (SIRI) were calculated.

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What researchers measure

Primary outcomes

  1. Systemic immune inflammation index (SII) and systemic inflammatory response index (SIRI)

    SII = neutrophil X platelet / lymphocyte count and the SIRI = neutrophil X monocyte / lymphocyte count

    Time frame: Preoperative hemogram values were obtained during routine anesthesia clinic evaluation, typically one day prior to surgery. Postoperative hemogram samples were collected on the day of surgery (postoperative day 0), within 4 to 12 hours after the procedur

Secondary outcomes

  1. Neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR)

    NLR = neutrophil / lymphocyte and PLR= platelet / lymphocyte

    Time frame: Preoperative hemogram values were obtained during routine anesthesia clinic evaluation, typically one day prior to surgery. Postoperative hemogram samples were collected on the day of surgery (postoperative day 0), within 4 to 12 hours after the procedur

  2. Total amount of opioids consumed postoperatively

    Total opioid consumption was calculated by converting all opioid doses to morphine milligram equivalents

    Time frame: Total amount of opioids requirement within the first 24 postoperative hours

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Study locations

1 site
  • Tokat Gaziosmanpasa University
    Tokat Province, 60100, Turkey (Türkiye)
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References and documents

Individual participant data

Plan to share: Yes — The data used to support the findings of this study can be obtained from the corresponding author on request.

Supporting information: Statistical analysis plan

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2020 to primary completion in Apr 2025, 63 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 14, 2025
First posted
May 22, 2025
StartActual
Jan 1, 2020
Primary completionActual
Apr 1, 2025
CompletionActual
May 10, 2025
Last update
May 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06984315
Responsible party
Ali Genc (Assistant professor, Tokat Gaziosmanpasa University) — Principal investigator
First posted
May 22, 2025
Start date
Jan 1, 2020
Primary completion
Apr 1, 2025
Completion
May 10, 2025
Last update
May 25, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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