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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

2026년 7월 6일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

68

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 터키 (Türkiye)
    • State/Province
      • Gaziantep, State/Province, 터키 (Türkiye), 27310
        • 모병
        • Gaziantep University Faculty of Medicine Hospital
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Berna KAYA UĞUR, Doç. Dr.
        • 부수사관:
          • Abdulkadir Uçar, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Sevoflurane General Anesthesia (SGA)
Participants in this group will receive sevoflurane general anesthesia according to standard institutional protocols for kidney transplantation.
의약품: 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).
다른 이름들:
  • Sevoflurane anesthesia
활성 비교기: Combined Spinal-Epidural Anesthesia (CSEA)
Participants in this group will receive combined spinal-epidural anesthesia as the anesthetic technique for kidney transplantation.
의약품: Bupivacaine and Morphine for 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.
다른 이름들:
  • CSE anesthesia

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Serum ferroptosis-related biomarkers (Fe, TFRC1, GPX4, MDA, ACSL4) and mitochondrial-derived peptides (humanin and MOTS-c)
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Delayed Graft Function (DGF)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Gaziantep

협력자

The Scientific and Technological Research Council of Turkey

수사관

  • 수석 연구원: Berna KAYA UĞUR, Doç. Dr., University of Gaziantep

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 3월 1일

기본 완료 (추정된)

2026년 10월 1일

연구 완료 (추정된)

2026년 10월 15일

연구 등록 날짜

최초 제출

2026년 6월 24일

QC 기준을 충족하는 최초 제출

2026년 6월 24일

처음 게시됨 (실제)

2026년 7월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 6일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2024/420
  • 962387 (기타 보조금/기금 번호: TUBITAK)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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