Comparison of the Effects of General Anesthesia and Combined Spinal-Epidural Anesthesia on Ferroptosis, Humanin and MOTS-c Levels in Renal Transplantation
- Sponsor
- University of Gaziantep
- Study ID
- NCT07678073
- Status
- Recruiting
Conditions
- Kidney
- Kidney Disease
- Kidney Disease, End-Stage
- Kidney Transplant
- Renal Transplant
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Sevoflurane General Anesthesia — DRUGParticipants will receive standardized sevoflurane general anesthesia according to institutional kidney transplantation protocols. Anesthesia induction will include preoxygenation with 100% oxygen for 3-5 minutes, followed by intravenous propofol (1.5-2.5 mg/kg), fentanyl (1-2 µg/kg), and rocuronium bromide (0.6 mg/kg). Endotracheal intubation will be performed after short mask ventilation using direct laryngoscopy, and correct placement will be confirmed by auscultation. Anesthesia maintenance will be provided with sevoflurane (1.5-2.0% end-tidal) in a 40-50% oxygen/air mixture and remifentanil infusion (0.05-0.2 µg/kg/min). Mechanical ventilation will be set to 6-8 mL/kg tidal volume, PEEP 5 cmH₂O, and end-tidal CO₂ 35-40 mmHg. At the end of surgery, sevoflurane will be discontinued, neuromuscular blockade will be reversed with sugammadex (2-4 mg/kg), and extubation will be performed after recovery. Postoperative analgesia will include subcutaneous morphine (0.1 mg/kg).
- Bupivacaine and Morphine for Combined Spinal-Epidural Anesthesia — DRUGParticipants will receive combined spinal-epidural anesthesia under sterile conditions according to institutional protocols. The L3-L4 interspace will be identified, and local anesthesia will be administered with lidocaine (2-3 mL, 2%). A Tuohy needle will be inserted using a midline approach, and the epidural space will be identified using loss-of-resistance technique. Spinal anesthesia will be achieved via intrathecal injection of 2.5 mL of 0.5% hyperbaric bupivacaine after confirmation of cerebrospinal fluid flow. An epidural catheter will then be placed and secured. Sedation will be provided with intravenous midazolam (1-2 mg), and oxygen will be administered via nasal cannula (4 L/min). Intraoperative analgesia will be maintained with epidural 0.25% bupivacaine as needed. At the end of surgery, epidural morphine (3 mg) combined with 0.25% bupivacaine will be administered for postoperative analgesia.
Study Details
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.
Key Dates
- First listed
- Jul 1, 2026
- Start date
- Mar 1, 2026
- Status verified
- Jul 2026
- Primary completion
- Oct 1, 2026
- Completion
- Oct 15, 2026
Study Design
- Enrollment
- 68 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Active Comparator: Sevoflurane General Anesthesia (SGA)Participants in this group will receive sevoflurane general anesthesia according to standard institutional protocols for kidney transplantation.
- Active Comparator: Combined Spinal-Epidural Anesthesia (CSEA)Participants in this group will receive combined spinal-epidural anesthesia as the anesthetic technique for kidney transplantation.
Primary Outcome Measure
Serum ferroptosis-related biomarkers (Fe, TFRC1, GPX4, MDA, ACSL4) and mitochondrial-derived peptides (humanin and MOTS-c) [ Time Frame: Immediately before anesthesia induction and immediately before extubation (intraoperative period) ]
Central Contacts
- Abdulkadir UÇAR, MD+90 534 030 89 56
- Berna KAYA UĞUR, Doç. Dr.+90 532 572 76 51
Related Studies
- Immune System Related Kidney DiseaseRecruiting · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Bethesda, Maryland
- Study of Combined Kidney and Blood Stem Cell Transplant From a Brother or Sister DonorPHASE1/PHASE2 · Recruiting · Jeffrey Veale, MD · Los Angeles, California
- Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF SystemRecruiting · C. R. Bard · La Jolla, California
- The KidneyCARE (Community Access to Research Equity) StudyRecruiting · Tufts Medical Center · Danville, Pennsylvania