Effects Of Propofol And Sevoflurane On Plasma Mirna Levels İn Living Kidney Donors

Sponsor
University of Gaziantep
Study ID
NCT07760402
Status
Recruiting
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Conditions

  • Kidney Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Sevoflurane — DRUG
    Inhalation anesthetic agent administered at a concentration of 1.5-2% with a 50% Air / 50% Oxygen mixture for the maintenance of general anesthesia.
  • propofol — DRUG
    Intravenous anesthetic agent administered via continuous TIVA infusion at a dose of 4-10 mg/kg/hour with a 50% Air / 50% Oxygen mixture for the maintenance of general anesthesia.

Study Details

Surgical interventions and associated tissue trauma induce a complex systemic inflammatory stress response characterized by the activation of neuroendocrine, metabolic, and immunological systems. Donor nephrectomy operations performed in living kidney donors are among the unique clinical models where these inflammatory cascades and cellular stress pathways are most intensely observed, due to major surgical trauma and unavoidable ischemia-reperfusion injury during organ clamping. Recent studies have demonstrated that microRNAs (miRNAs), which epigenetically regulate gene expression at the post-transcriptional level, serve as key determinants in perioperative medicine regarding immune response, resolution of inflammation, and cellular adaptation processes . Among our target molecules, miR-146a acts as a dominant, negative regulator (brake mechanism) of the innate immune response , while miR-155 plays an important role in the inflammatory response by triggering pro-inflammatory macrophage activation . Conversely, miR-21 displays an anti-apoptotic adaptation mechanism against tissue damage by directly targeting programmed cell death pathways . Propofol, an intravenous agent, and sevoflurane, a volatile anesthetic, are known to differentially impact microRNAs in circulating extracellular vesicles during major surgical interventions . The original value of this study lies in being the first randomized clinical trial in the literature to comprehensively examine the acute comparative effects of these two anesthesia techniques on perioperative inflammatory miRNA expression profiles in completely healthy living kidney donors. The objective is to comparatively evaluate the dynamic changes in plasma miR-146a, miR-155, and miR-21 levels under general anesthesia maintained with propofol or sevoflurane. Regarding the methodology, the research will be conducted on 34 voluntary living kidney donors aged 18-65 in the ASA I-II risk group, scheduled for elective donor nephrectomy at Gaziantep University Faculty of Medicine Şahinbey Training and Research Hospital, Department of Anesthesiology and Reanimation. Donors will be allocated into two equal groups (Group P: Propofol, n=17 and Group S: Sevoflurane, n=17) using a computer-assisted block randomization method, with anesthesia maintenance titrated to a Bispectral Index (BIS) of 40-60. Peripheral venous blood samples will be collected into K3-EDTA tubes at three different time points: before anesthesia induction (T0: basal), at the end of surgery (T1), and at the postoperative 24th hour (T2). In accordance with project management and data privacy principles, personal identity information will be masked, and each participant will be recorded in the system with a unique "File Number" (Dosya No). In the molecular phase conducted in coordination with the Department of Medical Genetics laboratory, total RNA isolation and cDNA synthesis will be performed from plasma samples separated under cold chain rules. Expression levels of target genes and the U6 snRNA internal control will be quantitatively analyzed in duplicate using Real-Time Quantitative PCR (RT-qPCR). Fold change ratios will be calculated using the method and analyzed with biostatistical methods including Shapiro-Wilk, Student's t-test, and Mann-Whitney U test. As for the widespread impact, the molecular findings to be obtained will elucidate the epigenetic reflections of general anesthesia applications on systemic inflammation and organ protection capacities for the first time. These results will lead to the development of the safest, evidence-based anesthesia protocols that will minimize the inflammatory load caused by surgical trauma at the cellular level in living kidney donors, increase donor comfort and postoperative recovery quality, and protect kidney graft quality against ischemic injury, providing a strong scientific foundation for international transplantation guidelines.

Key Dates

First listed
Aug 12, 2026
Start date
May 1, 2026
Status verified
Aug 2026
Primary completion
Oct 15, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: GROUP S
    General anesthesia maintenance will be provided using Sevoflurane at a concentration of 1.5-2% combined with a 50% Air / 50% Oxygen mixture. Standard monitoring and routine anesthesia induction protocols will be implemented.
  • Active Comparator: GROUP P
    General anesthesia maintenance will be provided using Total Intravenous Anesthesia (TIVA) via Propofol infusion at a dose of 4-10 mg/kg/hour combined with a 50% Air / 50% Oxygen mixture. Standard monitoring and routine anesthesia induction protocols will be implemented.

Primary Outcome Measure

Relative expression levels of plasma microRNAs (miR-146a, miR-155, and miR-21) [ Time Frame: Baseline (pre-induction), immediately at the end of surgery (post-extubation), and at the 24th postoperative hour. ]

Central Contacts

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