Comparison of the Effects of General Anesthesia and Combined Spinal-Epidural Anesthesia on Ferrop… (NCT07678073) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of the Effects of General Anesthesia and Combined Spinal-Epidural Anesthesia on Ferroptosis, Humanin and MOTS-c Levels in Renal Transplantation
Turkey (Türkiye)68 participantsStarted 2026-03-01
Plain-language summary
Renal transplantation is the most effective renal replacement therapy for patients with end-stage renal disease. Ischemia-reperfusion injury may adversely affect graft function and long-term outcomes. Ferroptosis has recently emerged as a potential mechanism involved in ischemia-reperfusion injury, while the mitochondrial-derived peptides humanin and MOTS-c are thought to exert protective effects against oxidative stress. However, the effects of different anesthetic techniques on these biomarkers in kidney transplant recipients have not been investigated.
This prospective controlled study aims to compare the effects of sevoflurane general anesthesia (SGA) and combined spinal-epidural anesthesia (CSEA) on serum ferroptosis markers, humanin, and MOTS-c levels in adult kidney transplant recipients. Blood samples will be obtained perioperatively for biomarker analysis.
The primary objective of the study is to evaluate the effects of the anesthetic technique on serum ferroptosis markers, humanin, and MOTS-c levels. Secondary objectives include evaluating early graft function and postoperative outcomes by assessing the incidence of delayed graft function, postoperative serum creatinine levels, requirement for dialysis, urine output, length of hospital stay, and the association of these outcomes with perioperative biomarker levels.
Who can participate
Age range
18 Years – 70 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:
* Patients aged 18-70 years with American Society of Anesthesiologists (ASA) physical status I-III.
* Patients scheduled for elective living-donor allogeneic kidney transplantation.
* Patients receiving sevoflurane-based general anesthesia as the anesthetic technique.
* Patients receiving combined spinal-epidural anesthesia as the anesthetic technique.
Exclusion Criteria:
* Patients younger than 18 years or older than 70 years.
* Patients undergoing deceased-donor kidney transplantation.
* Patients receiving total intravenous anesthesia (TIVA).
* Patients who decline to participate in the study or are unable to provide informed consent.
* Patients with American Society of Anesthesiologists (ASA) physical status IV or V.
* Patients with a history of previous organ transplantation.
* Patients with known or suspected mitochondrial disorders.
* Patients with a history of chronic corticosteroid use.
* Patients requiring red blood cell transfusion intraoperatively or within the first 24 postoperative hours.
* Patients with a primary warm ischemia time \>5 minutes, secondary warm ischemia time \>30 minutes, or cold ischemia time \>60 minutes.
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
Serum ferroptosis-related biomarkers (Fe, TFRC1, GPX4, MDA, ACSL4) and mitochondrial-derived peptides (humanin and MOTS-c)
Timeframe: Immediately before anesthesia induction and immediately before extubation (intraoperative period)