An interventional study of Sevoflurane and propofol in Kidney Transplant, sponsored by University of Gaziantep. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by University of Gaziantep · Not applicable, Interventional, and Basic science
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.
Following the approval of the Institutional Review Board (IRB), this prospective, comparative study will be conducted at the University Faculty of Medicine Hospital. The study will be concluded once the target number of eligible donors is reached. Written informed consent will be obtained from donors aged 18-65, classified as American Society of Anesthesiologists (ASA) physical status I-II, with a body mass index (BMI) below 35 kg/m², and scheduled for elective donor nephrectomy in the preoperative holding area before being transferred to the operating room. Informed consent forms will be obtained face-to-face by the investigators during the preoperative preparation process, prior to any clinical intervention, premedication, or randomization procedure.
Allocation of donors to the groups (Group S and Group P) will be performed in a 1:1 ratio using a computer-generated random numbers table via block randomization. To ensure strict allocation concealment, the assignments will be enclosed in sequentially numbered, opaque, sealed envelopes. The preparation of these envelopes will be handled by an independent researcher who is not involved in either the clinical phase of the study or the data analysis. Upon obtaining informed consent, the anesthesia team will open the corresponding sealed envelope in sequence and execute the assigned protocol, thereby preventing selection bias.
The Sevoflurane and Propofol methods utilized for anesthetic maintenance are part of the standard institutional routine application protocols of the Department of Anesthesiology and Reanimation. Donors will not receive any non-routine drug or dosage within the scope of this study. The randomization process is employed solely to determine which of the two standard and routine anesthetic regimens already available to the donor will be administered. Consequently, all anesthetic agents, intravenous administration sets, endotracheal tubes, and monitoring materials utilized intraoperatively are covered under the routine operational expenses of the hospital; no additional consumable materials will be introduced for research purposes.
A total of 34 donors enrolled in the study will be allocated into two groups via block randomization and the sealed envelope method to determine the maintenance regime of general anesthesia:
Sevoflurane and Propofol were selected as the comparative interventions due to their proven safety profiles and high preference rates in routine clinical practice, driven by their well-documented properties in preserving organ perfusion and ensuring rapid recovery. Both anesthetic agents are consistently and continuously stocked for routine clinical use in the hospital pharmacy. Potential adverse events, such as nausea, vomiting, shivering, or rare malignant hyperthermia associated with Sevoflurane, and injection pain, hypotension, or bradycardia associated with Propofol, will be monitored by the anesthesia team under standard monitoring and managed promptly according to institutional routine treatment protocols.
Upon arrival in the operating suite, standard monitoring-including Electrocardiography (ECG), Non-Invasive Blood Pressure (NIBP), Peripheral Oxygen Saturation (SpO2), and End-Tidal Carbon Dioxide (EtCO2)-will be established for all participating donors. To ensure pharmacological uniformity at the baseline phase between the groups, anesthesia induction will be performed using a standardized protocol in both groups as follows:
- Induction Protocol: All donors will routinely receive 0.03-0.05 mg/kg Midazolam, 2-2.5 mg/kg Propofol, 1-2 mcg/kg Fentanyl, and 0.6 mg/kg Rocuronium bromide for neuromuscular blockade, followed by endotracheal intubation.
Blood samples of 5 mL will be collected from the donors at three distinct clinical time points: prior to anesthesia induction (baseline value), at the end of surgery (post-extubation), and at the 24th postoperative hour. The blood sampling procedures will be performed during routine intravenous cannulation or through the existing intravenous line. Necessary medical precautions have been instituted to manage potential minor complications such as localized pain, hematoma, ecchymosis, or rare vasovagal syncope. The collected blood samples will be preserved by Dr. Tarik Oztuzcu at the Department of Medical Genetics, and plasma microRNA (miRNA) levels will be analyzed after the sample collection for all 34 donors is finalized.
MicroRNA Expression Methodology:
Within the scope of the project, expression levels of miR-146a, miR-155, miR-21, and the U6 gene will be analyzed in serum samples obtained by centrifuging the blood samples of the 34 donors.
University of Gaziantep is the lead sponsor of 105 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Sevoflurane
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.
Drug: propofol
Inhalation anesthetic agent administered at a concentration of 1.5-2% with a 50% Air / 50% Oxygen mixture for the maintenance of general anesthesia.
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.
Relative expression levels of plasma microRNAs (miR-146a, miR-155, and miR-21)
The relative changes in the expression levels of plasma miR-146a, miR-155, and miR-21 will be evaluated using blood samples. Total RNA will be isolated from serum samples using commercial kits, followed by complementary DNA (cDNA) synthesis and Quantitative Real-Time PCR (RT-PCR) array analysis. The 2\^-ΔΔCt method will be utilized to calculate relative gene expression folds, using U6 as an internal control reference gene.
Time frame: Baseline (pre-induction), immediately at the end of surgery (post-extubation), and at the 24th postoperative hour.
Plan to share: No
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Started May 2026 (actual). Primary completion is estimated for Oct 2026, 5 months after the start.
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Studies of the drugs tested here: Sevoflurane · Propofol