Kidney Disease, End-StageNCT07678073
Comparison of the Effects of General Anesthesia and Combined Spinal-Epidural Anesthesia on Ferroptosis, Humanin and MOTS-c Levels in Renal Transplantation
A study testing Sevoflurane General Anesthesia and Bupivacaine and Morphine for Combined Spinal-Epidural Anesthesia in people with Kidney Disease, End-Stage and Kidney Transplant, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Disease, End-Stage, Kidney Transplant, Kidney
- What is being tested?
- Sevoflurane General Anesthesia and Bupivacaine and Morphine for Combined Spinal-Epidural Anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziantep University Faculty of Medicine Hospital
Gaziantep, State/Province, 27310
Abdulkadir Uçar, MD, +90 534 030 89 56, drkadirucar@gmail.com
Berna KAYA UĞUR, Doç. Dr., +90 532 572 76 51, drkadirucar@gmail.com
About this study
Official title: Comparison of the Effects of General Anesthesia and Combined Spinal-Epidural Anesthesia on Ferroptosis, Humanin and MOTS-c Levels in Renal Transplantation: A Prospective Controlled Study
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.
Read the detailed description
Renal transplantation represents the most effective form of renal replacement therapy for patients with end-stage renal disease; however, ischemia-reperfusion injury remains a major determinant of early graft dysfunction and long-term transplant outcomes.
Ferroptosis, an iron-dependent form of regulated cell death characterized by lipid peroxidation, has recently been proposed as an important mechanism contributing to ischemia-reperfusion-related tissue injury. In addition, mitochondrial-derived peptides such as humanin and MOTS-c have been identified as key regulators of cellular stress responses and may exert protective effects against oxidative damage. Despite these emerging findings, the influence of anesthetic technique on ferroptosis-related pathways and mitochondrial protective peptides in kidney transplantation has not yet been fully elucidated.
This prospective controlled study is designed to evaluate the effect of anesthetic technique on perioperative biochemical and clinical outcomes in renal transplant recipients. Adult patients undergoing kidney transplantation will receive either sevoflurane-based general anesthesia (SGA) or combined spinal-epidural anesthesia (CSEA). The two anesthetic strategies will be compared in terms of their effects on circulating ferroptosis-related biomarkers, as well as serum levels of humanin and MOTS-c.
Peripheral arterial blood samples will be obtained at two standardized points: immediately before anesthesia induction (T1) and immediately prior to extubation (T2). Following collection, blood samples will be centrifuged, and serum aliquots will be stored under appropriate conditions at -80°C until batch analysis. Serum levels of ferroptosis-related biomarkers, humanin, and MOTS-c will be measured using enzyme-linked immunosorbent assay (ELISA) and standard biochemical techniques.
The primary objective of the study is to assess the effect of anesthetic technique on perioperative changes in serum ferroptosis-related biomarkers and mitochondrial-derived peptides (humanin and MOTS-c).
The secondary objectives are to evaluate early postoperative graft function and clinical recovery parameters, including incidence of delayed graft function, postoperative serum creatinine levels, requirement for dialysis, urine output, and length of hospital stay. In addition, the association between perioperative biomarker levels and clinical outcomes will be analyzed to explore potential predictive relationships.
It is anticipated that this study will provide further insight into the relationship between anesthetic technique, ferroptosis pathways, and mitochondrial-mediated cytoprotection in renal transplantation. The results may contribute to improved understanding of perioperative biological responses and support optimization of anesthetic strategies aimed at enhancing graft outcomes.
- Being tested
- Sevoflurane General Anesthesia, Bupivacaine and Morphine for Combined Spinal-Epidural Anesthesia
- Keywords
- GENERAL ANESTHESIA, REGIONAL ANESTHESIA, KIDNEY TRANSPLANTATION, CELLULAR STRESS RESPONSE, CELLULAR STRESS, ANESTHESIA, HUMANIN, MOTS-c, FERROPTOSIS
- Medical subject headings
- Kidney Failure, Chronic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane General AnesthesiaDrug
Also called Sevoflurane anesthesia
Participants 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 AnesthesiaDrug
Also called CSE anesthesia
Participants 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 group | Role | What they receive |
|---|---|---|
| Sevoflurane General Anesthesia (SGA) | Active comparator | Participants in this group will receive sevoflurane general anesthesia according to standard institutional protocols for kidney transplantation. Receives: Drug: Sevoflurane General Anesthesia |
| Combined Spinal-Epidural Anesthesia (CSEA) | Active comparator | Participants in this group will receive combined spinal-epidural anesthesia as the anesthetic technique for kidney transplantation. Receives: Drug: Bupivacaine and Morphine for Combined Spinal-Epidural Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum ferroptosis-related biomarkers (Fe, TFRC1, GPX4, MDA, ACSL4) and mitochondrial-derived peptides (humanin and MOTS-c)
The primary outcome is the perioperative change in serum levels of ferroptosis-related biomarkers and mitochondrial-derived peptides, including humanin and MOTS-c, between two standardized time points. Blood samples will be collected immediately prior to anesthesia induction and immediately prior to extubation. Biomarker levels will be quantified using ELISA-based and standard biochemical methods. The primary comparison will evaluate differences in biomarker changes between the sevoflurane general anesthesia (SGA) and combined spinal-epidural anesthesia (CSEA) groups.
Measured: Immediately before anesthesia induction and immediately before extubation (intraoperative period)
Secondary outcomes (6)
Delayed Graft Function (DGF)
Delayed graft function will be defined as the requirement for dialysis within the first 7 postoperative days or a reduction in serum creatinine of less than 30% during the first 48 hours after transplantation. The incidence of delayed graft function will be compared between the study groups.
Measured: Postoperative days 0-7
Postoperative Serum Creatinine Levels
Serial serum creatinine levels will be measured daily during the first postoperative week to evaluate early renal graft function and recovery.
Measured: Postoperative days 1-7
Requirement for Postoperative Dialysis
The need for dialysis during the early post-transplant period will be recorded as a clinical indicator of graft dysfunction.
Measured: Within first 7 postoperative days
Urine Output
Hourly urine output will be monitored to assess immediate graft perfusion and early functional recovery.
Measured: Intraoperative period and first 24 postoperative hours
Length of Hospital Stay
Total duration of postoperative hospitalization will be recorded as a measure of overall recovery and clinical course.
Measured: From surgery until discharge (up to 30 days)
Association Between Biomarkers and Clinical Outcomes
Correlation analyses will be performed to evaluate the relationship between perioperative biomarker levels (ferroptosis markers, humanin, and MOTS-c) and early clinical outcomes, including delayed graft function, serum creatinine levels, and urine output.
Measured: Perioperative period and first 7 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Mar 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Kidney Disease, End-StageStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will use a parallel assignment interventional model. Participants will be assigned to one of two study groups: sevoflurane general anesthesia (SGA) or combined spinal-epidural anesthesia (CSEA). Outcomes will be compared between the two groups to evaluate the effect of anesthetic technique on perioperative biomarker levels and clinical outcomes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Berna Kaya Ugur, University of Gaziantep
- Investigators
- Berna KAYA UĞUR, Doç. Dr., Principal investigator, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678073
- Sponsor's protocol ID
- 2024/420
- Other IDs
- 962387
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2026
- Last updated
- 8 Jul 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 publicly shared. Data may be available from the corresponding investigator upon reasonable request and after approval by the local ethics committee.
Publications
Ivascu R, Torsin LI, Hostiuc L, Nitipir C, Corneci D, Dutu M. The Surgical Stress Response and Anesthesia: A Narrative Review. J Clin Med. 2024 May 20;13(10):3017. doi: 10.3390/jcm13103017.
PubMed 38792558Siedlecki A, Irish W, Brennan DC. Delayed graft function in the kidney transplant. Am J Transplant. 2011 Nov;11(11):2279-96. doi: 10.1111/j.1600-6143.2011.03754.x. Epub 2011 Sep 19.
PubMed 21929642Perico N, Cattaneo D, Sayegh MH, Remuzzi G. Delayed graft function in kidney transplantation. Lancet. 2004 Nov 13-19;364(9447):1814-27. doi: 10.1016/S0140-6736(04)17406-0.
PubMed 15541456Zheng Y, Wei Z, Wang T. MOTS-c: A promising mitochondrial-derived peptide for therapeutic exploitation. Front Endocrinol (Lausanne). 2023 Jan 25;14:1120533. doi: 10.3389/fendo.2023.1120533. eCollection 2023.
PubMed 36761202Yong CQY, Tang BL. A Mitochondrial Encoded Messenger at the Nucleus. Cells. 2018 Aug 13;7(8):105. doi: 10.3390/cells7080105.
PubMed 30104535Wan W, Zhang L, Lin Y, Rao X, Wang X, Hua F, Ying J. Mitochondria-derived peptide MOTS-c: effects and mechanisms related to stress, metabolism and aging. J Transl Med. 2023 Jan 20;21(1):36. doi: 10.1186/s12967-023-03885-2.
PubMed 36670507Coradduzza D, Congiargiu A, Chen Z, Cruciani S, Zinellu A, Carru C, Medici S. Humanin and Its Pathophysiological Roles in Aging: A Systematic Review. Biology (Basel). 2023 Apr 6;12(4):558. doi: 10.3390/biology12040558.
PubMed 37106758Gong Z, Tas E, Muzumdar R. Humanin and age-related diseases: a new link? Front Endocrinol (Lausanne). 2014 Dec 4;5:210. doi: 10.3389/fendo.2014.00210. eCollection 2014.
PubMed 25538685Gong Z, Goetzman E, Muzumdar RH. Cardio-protective role of Humanin in myocardial ischemia-reperfusion. Biochim Biophys Acta Gen Subj. 2022 Feb;1866(2):130066. doi: 10.1016/j.bbagen.2021.130066. Epub 2021 Dec 9.
PubMed 34896254Hazafa A, Batool A, Ahmad S, Amjad M, Chaudhry SN, Asad J, Ghuman HF, Khan HM, Naeem M, Ghani U. Humanin: A mitochondrial-derived peptide in the treatment of apoptosis-related diseases. Life Sci. 2021 Jan 1;264:118679. doi: 10.1016/j.lfs.2020.118679. Epub 2020 Oct 29.
PubMed 33130077Wang W, Chen J, Zhan L, Zou H, Wang L, Guo M, Gao H, Xu J, Wu W. Iron and ferroptosis in kidney disease: molecular and metabolic mechanisms. Front Immunol. 2025 Feb 5;16:1531577. doi: 10.3389/fimmu.2025.1531577. eCollection 2025.
PubMed 39975561Feng Q, Yu X, Qiao Y, Pan S, Wang R, Zheng B, Wang H, Ren KD, Liu H, Yang Y. Ferroptosis and Acute Kidney Injury (AKI): Molecular Mechanisms and Therapeutic Potentials. Front Pharmacol. 2022 Apr 19;13:858676. doi: 10.3389/fphar.2022.858676. eCollection 2022.
PubMed 35517803Liu J, Han X, Zhou J, Leng Y. Molecular Mechanisms of Ferroptosis and Their Involvement in Acute Kidney Injury. J Inflamm Res. 2023 Nov 2;16:4941-4951. doi: 10.2147/JIR.S427505. eCollection 2023.
PubMed 37936596
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of General Anesthesia and Combined Spinal-Epidural Anesthesia on Ferroptosis, Humanin and MOTS-c Levels in Renal Transplantation: A Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT07678073
- Acronym / sponsor ID
- 2024/420
- Keywords
- GENERAL ANESTHESIA, REGIONAL ANESTHESIA, KIDNEY TRANSPLANTATION, CELLULAR STRESS RESPONSE, CELLULAR STRESS, ANESTHESIA, HUMANIN, MOTS-c
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 1 Jul 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.
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.
Detailed description
Renal transplantation represents the most effective form of renal replacement therapy for patients with end-stage renal disease; however, ischemia-reperfusion injury remains a major determinant of early graft dysfunction and long-term transplant outcomes.
Ferroptosis, an iron-dependent form of regulated cell death characterized by lipid peroxidation, has recently been proposed as an important mechanism contributing to ischemia-reperfusion-related tissue injury. In addition, mitochondrial-derived peptides such as humanin and MOTS-c have been identified as key regulators of cellular stress responses and may exert protective effects against oxidative damage. Despite these emerging findings, the influence of anesthetic technique on ferroptosis-related pathways and mitochondrial protective peptides in kidney transplantation has not yet been fully elucidated.
This prospective controlled study is designed to evaluate the effect of anesthetic technique on perioperative biochemical and clinical outcomes in renal transplant recipients. Adult patients undergoing kidney transplantation will receive either sevoflurane-based general anesthesia (SGA) or combined spinal-epidural anesthesia (CSEA). The two anesthetic strategies will be compared in terms of their effects on circulating ferroptosis-related biomarkers, as well as serum levels of humanin and MOTS-c.
Peripheral arterial blood samples will be obtained at two standardized points: immediately before anesthesia induction (T1) and immediately prior to extubation (T2). Following collection, blood samples will be centrifuged, and serum aliquots will be stored under appropriate conditions at -80°C until batch analysis. Serum levels of ferroptosis-related biomarkers, humanin, and MOTS-c will be measured using enzyme-linked immunosorbent assay (ELISA) and standard biochemical techniques.
The primary objective of the study is to assess the effect of anesthetic technique on perioperative changes in serum ferroptosis-related biomarkers and mitochondrial-derived peptides (humanin and MOTS-c).
The secondary objectives are to evaluate early postoperative graft function and clinical recovery parameters, including incidence of delayed graft function, postoperative serum creatinine levels, requirement for dialysis, urine output, and length of hospital stay. In addition, the association between perioperative biomarker levels and clinical outcomes will be analyzed to explore potential predictive relationships.
It is anticipated that this study will provide further insight into the relationship between anesthetic technique, ferroptosis pathways, and mitochondrial-mediated cytoprotection in renal transplantation. The results may contribute to improved understanding of perioperative biological responses and support optimization of anesthetic strategies aimed at enhancing graft outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will use a parallel assignment interventional model. Participants will be assigned to one of two study groups: sevoflurane general anesthesia (SGA) or combined spinal-epidural anesthesia (CSEA). Outcomes will be compared between the two groups to evaluate the effect of anesthetic technique on perioperative biomarker levels and clinical outcomes.
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane General Anesthesia (SGA) | Active comparator | Drug: Sevoflurane General AnesthesiaParticipants in this group will receive sevoflurane general anesthesia according to standard institutional protocols for kidney transplantation. |
| Combined Spinal-Epidural Anesthesia (CSEA) | Active comparator | Drug: Bupivacaine and Morphine for Combined Spinal-Epidural AnesthesiaParticipants in this group will receive combined spinal-epidural anesthesia as the anesthetic technique for kidney transplantation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| Sevoflurane General AnesthesiaAlso: Sevoflurane anesthesiaParticipants 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). | Drug | Sevoflurane General Anesthesia (SGA) |
| Bupivacaine and Morphine for Combined Spinal-Epidural AnesthesiaAlso: CSE anesthesiaParticipants 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. | Drug | Combined Spinal-Epidural Anesthesia (CSEA) |
Primary outcome
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)
The primary outcome is the perioperative change in serum levels of ferroptosis-related biomarkers and mitochondrial-derived peptides, including humanin and MOTS-c, between two standardized time points. Blood samples will be collected immediately prior to anesthesia induction and immediately prior to extubation. Biomarker levels will be quantified using ELISA-based and standard biochemical methods. The primary comparison will evaluate differences in biomarker changes between the sevoflurane general anesthesia (SGA) and combined spinal-epidural anesthesia (CSEA) groups.
6 secondary outcomes
Delayed Graft Function (DGF)
Time frame: Postoperative days 0-7
Postoperative Serum Creatinine Levels
Time frame: Postoperative days 1-7
Requirement for Postoperative Dialysis
Time frame: Within first 7 postoperative days
Urine Output
Time frame: Intraoperative period and first 24 postoperative hours
Length of Hospital Stay
Time frame: From surgery until discharge (up to 30 days)
Association Between Biomarkers and Clinical Outcomes
Time frame: Perioperative period and first 7 postoperative days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 38792558Ivascu R, Torsin LI, Hostiuc L, Nitipir C, Corneci D, Dutu M. The Surgical Stress Response and Anesthesia: A Narrative Review. J Clin Med. 2024 May 20;13(10):3017. doi: 10.3390/jcm13103017.
- Background: PubMed 21929642Siedlecki A, Irish W, Brennan DC. Delayed graft function in the kidney transplant. Am J Transplant. 2011 Nov;11(11):2279-96. doi: 10.1111/j.1600-6143.2011.03754.x. Epub 2011 Sep 19.
- Background: PubMed 15541456Perico N, Cattaneo D, Sayegh MH, Remuzzi G. Delayed graft function in kidney transplantation. Lancet. 2004 Nov 13-19;364(9447):1814-27. doi: 10.1016/S0140-6736(04)17406-0.
- Background: PubMed 36761202Zheng Y, Wei Z, Wang T. MOTS-c: A promising mitochondrial-derived peptide for therapeutic exploitation. Front Endocrinol (Lausanne). 2023 Jan 25;14:1120533. doi: 10.3389/fendo.2023.1120533. eCollection 2023.
- Background: PubMed 30104535Yong CQY, Tang BL. A Mitochondrial Encoded Messenger at the Nucleus. Cells. 2018 Aug 13;7(8):105. doi: 10.3390/cells7080105.
- Background: PubMed 36670507Wan W, Zhang L, Lin Y, Rao X, Wang X, Hua F, Ying J. Mitochondria-derived peptide MOTS-c: effects and mechanisms related to stress, metabolism and aging. J Transl Med. 2023 Jan 20;21(1):36. doi: 10.1186/s12967-023-03885-2.
- Background: PubMed 37106758Coradduzza D, Congiargiu A, Chen Z, Cruciani S, Zinellu A, Carru C, Medici S. Humanin and Its Pathophysiological Roles in Aging: A Systematic Review. Biology (Basel). 2023 Apr 6;12(4):558. doi: 10.3390/biology12040558.
- Background: PubMed 25538685Gong Z, Tas E, Muzumdar R. Humanin and age-related diseases: a new link? Front Endocrinol (Lausanne). 2014 Dec 4;5:210. doi: 10.3389/fendo.2014.00210. eCollection 2014.
- Background: PubMed 34896254Gong Z, Goetzman E, Muzumdar RH. Cardio-protective role of Humanin in myocardial ischemia-reperfusion. Biochim Biophys Acta Gen Subj. 2022 Feb;1866(2):130066. doi: 10.1016/j.bbagen.2021.130066. Epub 2021 Dec 9.
- Background: PubMed 33130077Hazafa A, Batool A, Ahmad S, Amjad M, Chaudhry SN, Asad J, Ghuman HF, Khan HM, Naeem M, Ghani U. Humanin: A mitochondrial-derived peptide in the treatment of apoptosis-related diseases. Life Sci. 2021 Jan 1;264:118679. doi: 10.1016/j.lfs.2020.118679. Epub 2020 Oct 29.
- Background: PubMed 39975561Wang W, Chen J, Zhan L, Zou H, Wang L, Guo M, Gao H, Xu J, Wu W. Iron and ferroptosis in kidney disease: molecular and metabolic mechanisms. Front Immunol. 2025 Feb 5;16:1531577. doi: 10.3389/fimmu.2025.1531577. eCollection 2025.
- Background: PubMed 35517803Feng Q, Yu X, Qiao Y, Pan S, Wang R, Zheng B, Wang H, Ren KD, Liu H, Yang Y. Ferroptosis and Acute Kidney Injury (AKI): Molecular Mechanisms and Therapeutic Potentials. Front Pharmacol. 2022 Apr 19;13:858676. doi: 10.3389/fphar.2022.858676. eCollection 2022.
- The provided link refers to the official website of Gaziantep University Faculty of Medicine Hospital, where the study will be conducted and institutional information can be accessed.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared. Data may be available from the corresponding investigator upon reasonable request and after approval by the local ethics committee.
Related trials for Kidney Disease, End-Stage
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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.
Berna KAYA UĞUR, Doç. Dr. principal investigator
University of Gaziantep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane General Anesthesia and Bupivacaine and Morphine for Combined Spinal-Epidural Anesthesia in people with Kidney Disease, End-Stage and Kidney Transplant, run by University of Gaziantep 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 8 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdulkadir UÇAR, MD (+90 534 030 89 56, drkadirucar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07678073, which also lists 13 linked publications.
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 8 Jul 2026.