Comparison of the Effects of General Anesthesia and Spinal Anesthesia on Tissue Perfusion in Pati… (NCT07474480) | Clinical Trial Compass
CompletedNot Applicable
Comparison of the Effects of General Anesthesia and Spinal Anesthesia on Tissue Perfusion in Patients Undergoing Lower Extremity Surgery
Turkey (Türkiye)60 participantsStarted 2025-03-25
Plain-language 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. 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage AUC Loss During Tourniquet Inflation
Timeframe: From tourniquet inflation to tourniquet deflation during surgery
Trial details
NCT IDNCT07474480
SponsorProf. Dr. Cemil Tascıoglu Education and Research Hospital Organization