Tissue PerfusionPerf-LEXNCT07474480
Comparison of the Effects of General Anesthesia and Spinal Anesthesia on Tissue Perfusion in Patients Undergoing Lower Extremity Surgery
An observational study of Tissue Perfusion and Lower Extremity Surgery, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
This prospective, single-center observational study compares the effects of general anesthesia and spinal anesthesia on tissue perfusion in patients undergoing lower extremity surgery with tourniquet use. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tissue Perfusion, Lower Extremity Surgery, Tourniquet-Induced Ischemia-Reperfusion Injury
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2025to 25 Dec 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 65 years
- All sexes
- Adult, Older adult
Study population: Adults aged 18 to 65 years with ASA physical status I-II who were scheduled for elective lower extremity orthopedic surgery with tourniquet use at Prof. Dr. Cemil Taşcıoğlu City Hospital between 01 March 2025 and 30 September 2025. Eligible patients were assessed consecutively and enrolled after providing informed consent. Patients were analyzed in 2 observational cohorts according to anesthesia method used in routine clinical practice: general anesthesia and spinal anesthesia.
Who may be able to join
- Age 18 to 65 years
- Scheduled for elective lower extremity orthopedic surgery
- ASA physical status I or II
- Expected operation duration 30 to 120 minutes
- Expected tourniquet duration 30 to 90 minutes
- Informed about the anesthesia method and agreed to participate voluntarily
- No contraindication to neuraxial block
Who cannot join
- Refusal to participate
- History of peripheral arterial disease, diabetic neuropathy, or advanced vascular insufficiency
- Severe or uncontrolled systemic disease, including ASA III or higher
- Coagulopathy, local infection, or contraindication to spinal anesthesia
- Body mass index greater than 35 kg/m²
- Pregnancy or impaired consciousness
Show all 9Show fewer
- Intraoperative hemodynamic instability or anticipated instability
- Need for additional intraoperative sedative or analgesic medication
- Inability to obtain adequate and reliable NIRS signal for technical reasons
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cemil Tasciogu Research and Training Hospital
Istanbul, Sisli
About this study
Official title: Comparison of the Effects of Anesthesia Techniques on Tissue Perfusion in Patients Undergoing Lower Extremity Surgery With Tourniquet Use
This prospective, single-center observational study compares the effects of general anesthesia and spinal anesthesia on tissue perfusion in patients undergoing lower extremity surgery with tourniquet use. Tissue oxygenation in the limb distal to the tourniquet is monitored noninvasively using near-infrared spectroscopy (NIRS), and perfusion loss is quantified using an area-under-the-curve (AUC) approach. The primary objective is to evaluate whether spinal anesthesia better preserves distal tissue oxygenation during tourniquet inflation compared with general anesthesia. Secondary objectives are to assess reperfusion response after tourniquet release using changes in NIRS values at 20 minutes relative to baseline, the presence of early hyperemia (rSO₂ overshoot), and the association between tourniquet duration and perfusion loss. Additional exploratory analyses evaluate selected metabolic and inflammatory markers, including pH, lactate, and potassium.
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 |
|---|---|---|
| General Anesthesia Group | Patients undergoing lower extremity surgery under general anesthesia. | |
| Spinal Anesthesia Group | Patients undergoing lower extremity surgery under spinal anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage AUC Loss During Tourniquet Inflation
Distal tissue oxygenation/perfusion loss measured by near-infrared spectroscopy (NIRS) as the percentage area-under-the-curve (AUC) loss of regional tissue oxygen saturation (rSO₂) during tourniquet inflation.
Measured: From tourniquet inflation to tourniquet deflation during surgery
Secondary outcomes (3)
Reperfusion Response Assessed by ΔNIRS
Change in distal regional tissue oxygen saturation (rSO₂) measured by NIRS, defined as the 20th minute after tourniquet deflation minus baseline value.
Measured: Baseline to 20 minutes after tourniquet deflation
Early Hyperemia (rSO₂ Overshoot)
Mean Change in Regional Oxygen Saturation (rSO₂) Above Baseline After Tourniquet Deflation
Measured: Within 5 minutes after tourniquet deflation
Association Between Tourniquet Duration and Percentage AUC Loss
Correlation between tourniquet duration and percentage AUC loss in distal tissue oxygenation/perfusion.
Measured: Intraoperative period, during tourniquet use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start25 Mar 2025
- Primary completion12 Sep 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue PerfusionStudies 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
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taylan Kırdan, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474480
- Sponsor's protocol ID
- TK-LEP-001
- Acronym
- Perf-LEX
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no formal data-sharing plan was established for this thesis-based observational study, and sharing is limited by institutional and ethics requirements.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Anesthesia Techniques on Tissue Perfusion in Patients Undergoing Lower Extremity Surgery With Tourniquet Use
- ClinicalTrials.gov ID
- NCT07474480
- Acronym / sponsor ID
- Perf-LEX / TK-LEP-001
- Conditions
- Tissue Perfusion, Lower Extremity Surgery, Tourniquet-Induced Ischemia-Reperfusion Injury, General Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 16 Mar 2026 (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.
This prospective, single-center observational study compares the effects of general anesthesia and spinal anesthesia on tissue perfusion in patients undergoing lower extremity surgery with tourniquet use. Tissue oxygenation in the limb distal to the tourniquet is monitored noninvasively using near-infrared spectroscopy (NIRS), and perfusion loss is quantified using an area-under-the-curve (AUC) approach. The primary objective is to evaluate whether spinal anesthesia better preserves distal tissue oxygenation during tourniquet inflation compared with general anesthesia. Secondary objectives are to assess reperfusion response after tourniquet release using changes in NIRS values at 20 minutes relative to baseline, the presence of early hyperemia (rSO₂ overshoot), and the association between tourniquet duration and perfusion loss. Additional exploratory analyses evaluate selected metabolic and inflammatory markers, including pH, lactate, and potassium.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia Group | – | –Patients undergoing lower extremity surgery under general anesthesia. |
| Spinal Anesthesia Group | – | –Patients undergoing lower extremity surgery under spinal anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 to 65 years with ASA physical status I-II who were scheduled for elective lower extremity orthopedic surgery with tourniquet use at Prof. Dr. Cemil Taşcıoğlu City Hospital between 01 March 2025 and 30 September 2025. Eligible patients were assessed consecutively and enrolled after providing informed consent. Patients were analyzed in 2 observational cohorts according to anesthesia method used in routine clinical practice: general anesthesia and spinal anesthesia.
Key inclusion criteria (7 listed)
- Age 18 to 65 years
- Scheduled for elective lower extremity orthopedic surgery
- ASA physical status I or II
- Expected operation duration 30 to 120 minutes
- Expected tourniquet duration 30 to 90 minutes
Key exclusion criteria (9 listed)
- Refusal to participate
- History of peripheral arterial disease, diabetic neuropathy, or advanced vascular insufficiency
- Severe or uncontrolled systemic disease, including ASA III or higher
- Coagulopathy, local infection, or contraindication to spinal anesthesia
- Body mass index greater than 35 kg/m²
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
Percentage AUC Loss During Tourniquet Inflation
Time frame: From tourniquet inflation to tourniquet deflation during surgery
Distal tissue oxygenation/perfusion loss measured by near-infrared spectroscopy (NIRS) as the percentage area-under-the-curve (AUC) loss of regional tissue oxygen saturation (rSO₂) during tourniquet inflation.
3 secondary outcomes
Reperfusion Response Assessed by ΔNIRS
Time frame: Baseline to 20 minutes after tourniquet deflation
Early Hyperemia (rSO₂ Overshoot)
Time frame: Within 5 minutes after tourniquet deflation
Association Between Tourniquet Duration and Percentage AUC Loss
Time frame: Intraoperative period, during tourniquet use
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 28 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no formal data-sharing plan was established for this thesis-based observational study, and sharing is limited by institutional and ethics requirements.
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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 Tissue Perfusion and Lower Extremity Surgery, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization 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 7 inclusion and 9 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 28 May 2026. 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?
Percentage AUC Loss During Tourniquet Inflation (time frame: From tourniquet inflation to tourniquet deflation during surgery). 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 28 May 2026.