Spinal AneshtesiaNCT06984315
Effects of Anesthesia Type on Inflammatory Response
An observational study of Spinal Aneshtesia and General Anesthetic, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Aneshtesia, General Anesthetic, Inflammation
- What is being tested?
- The effects of the groups on perioperative inflammation changes were compared.
- How many people
- 849 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 10 May 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Between January 2020 and April 2025, data from 849 patients who underwent total knee arthroplasty were retrospectively reviewed.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University
Tokat Province, 60100
About this study
Official title: Spinal Anesthesia Mitigates Systemic Inflammatory Response Compared to General Anesthesia in Total Knee Arthroplasty: A Retrospective Study
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.
- Conditions
- Spinal Aneshtesia, General Anesthetic, Inflammation, Neutrophils, Total Knee Arthroplasty, White Blood Cells
- Being tested
- The effects of the groups on perioperative inflammation changes were compared.
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The effects of the groups on perioperative inflammation changes were compared.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Group S | Underwent total knee arthroplasty under spinal anesthesia Receives: Other: The effects of the groups on perioperative inflammation changes were compared. | |
| Group G | Underwent total knee arthroplasty under general anesthesia Receives: Other: The effects of the groups on perioperative inflammation changes were compared. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (2)
Neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR)
NLR = neutrophil / lymphocyte and PLR= platelet / lymphocyte
Measured: 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
Total amount of opioids consumed postoperatively
Total opioid consumption was calculated by converting all opioid doses to morphine milligram equivalents
Measured: Total amount of opioids requirement within the first 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Jan 2020
- Primary completion1 Apr 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AneshtesiaStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 849 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Genc, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984315
- Sponsor's protocol ID
- 25-MOBAEK-160
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data used to support the findings of this study can be obtained from the corresponding author on request.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Anesthesia Mitigates Systemic Inflammatory Response Compared to General Anesthesia in Total Knee Arthroplasty: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06984315
- Acronym / sponsor ID
- 25-MOBAEK-160
- Conditions
- Spinal Aneshtesia, General Anesthetic, Inflammation, Neutrophils, Total Knee Arthroplasty, White Blood Cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 849 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 22 May 2025 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | – | Other: The effects of the groups on perioperative inflammation changes were compared.Underwent total knee arthroplasty under spinal anesthesia |
| Group G | – | Other: The effects of the groups on perioperative inflammation changes were compared.Underwent total knee arthroplasty under general anesthesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between January 2020 and April 2025, data from 849 patients who underwent total knee arthroplasty were retrospectively reviewed.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The 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. | Other | Group G, Group S |
Primary outcome
Systemic immune inflammation index (SII) and systemic inflammatory response index (SIRI)
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
SII = neutrophil X platelet / lymphocyte count and the SIRI = neutrophil X monocyte / lymphocyte count
2 secondary outcomes
Neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR)
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
Total amount of opioids consumed postoperatively
Time frame: Total amount of opioids requirement within the first 24 postoperative hours
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 25 May 2025.
- Individual participant dataSharing planned: Yes. The data used to support the findings of this study can be obtained from the corresponding author on request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Spinal Aneshtesia and General Anesthetic, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
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 3 inclusion and 8 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 25 May 2025. 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 Turkey (Türkiye). 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?
Systemic immune inflammation index (SII) and systemic inflammatory response index (SIRI) (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2025.