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COMPARISON OF THE EFFECTS OF GENERAL ANESTHESIA AND COMBINED SPINAL-EPIDURAL ANESTHESIA ON FERROPTOSIS, HUMANIN, AND MOTS-C LEVELS IN RENAL TRANSPLANTATION

24 giugno 2026 aggiornato da: Berna Kaya Ugur, University of Gaziantep

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

68

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Turchia (Türkiye)
    • State/Province
      • Gaziantep, State/Province, Turchia (Türkiye), 27310
        • Reclutamento
        • Gaziantep University Faculty of Medicine Hospital
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Berna KAYA UĞUR, Doç. Dr.
        • Sub-investigatore:
          • Abdulkadir Uçar, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Sevoflurane General Anesthesia (SGA)
Participants in this group will receive sevoflurane general anesthesia according to standard institutional protocols for kidney transplantation.
Procedura: Sevoflurane General 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).
Altri nomi:
  • Sevoflurane anesthesia
Comparatore attivo: Combined Spinal-Epidural Anesthesia (CSEA)
Participants in this group will receive combined spinal-epidural anesthesia as the anesthetic technique for kidney transplantation.
Procedura: Combined Spinal-Epidural 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.
Altri nomi:
  • CSE anesthesia

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Serum ferroptosis-related biomarkers (Fe, TFRC1, GPX4, MDA, ACSL4) and mitochondrial-derived peptides (humanin and MOTS-c)
Lasso di tempo: 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.
Immediately before anesthesia induction and immediately before extubation (intraoperative period)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Delayed Graft Function (DGF)
Lasso di tempo: Postoperative days 0-7
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.
Postoperative days 0-7
Postoperative Serum Creatinine Levels
Lasso di tempo: Postoperative days 1-7
Serial serum creatinine levels will be measured daily during the first postoperative week to evaluate early renal graft function and recovery.
Postoperative days 1-7
Requirement for Postoperative Dialysis
Lasso di tempo: Within first 7 postoperative days
The need for dialysis during the early post-transplant period will be recorded as a clinical indicator of graft dysfunction.
Within first 7 postoperative days
Urine Output
Lasso di tempo: Intraoperative period and first 24 postoperative hours
Hourly urine output will be monitored to assess immediate graft perfusion and early functional recovery.
Intraoperative period and first 24 postoperative hours
Length of Hospital Stay
Lasso di tempo: From surgery until discharge (up to 30 days)
Total duration of postoperative hospitalization will be recorded as a measure of overall recovery and clinical course.
From surgery until discharge (up to 30 days)
Association Between Biomarkers and Clinical Outcomes
Lasso di tempo: Perioperative period and first 7 postoperative days
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.
Perioperative period and first 7 postoperative days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Gaziantep

Collaboratori

The Scientific and Technological Research Council of Turkey

Investigatori

  • Investigatore principale: Berna KAYA UĞUR, Doç. Dr., University of Gaziantep

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 marzo 2026

Completamento primario (Stimato)

1 ottobre 2026

Completamento dello studio (Stimato)

15 ottobre 2026

Date di iscrizione allo studio

Primo inviato

24 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 giugno 2026

Primo Inserito (Effettivo)

1 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2024/420
  • 962387 (Altro numero di sovvenzione/finanziamento: TUBITAK)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Malattie rare

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