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NCT Number: NCT02559297

Effects of Sevoflurane and Desflurane on Treg

This prospective interventional study aims to compare sevoflurane and desflurane anesthetic agents on regulatory T cell (Treg) numbers and its cytokine production in patients undergoing Living Donor Kidney Transplant (LDKT).

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Key information

Conditions

Transplant; Failure, Kidney

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ramathibodi Hospital

Ratchathewi, Bangkok, 10400, Thailand

About this study

All patients with end stage renal disease (ESRD) need renal replacement therapy, either dialysis or kidney transplantation. Dialysis, despite its effectiveness in prolonging ESRD patients' lives, is a burden. Successfulness in kidney transplantation will restore good quality of life in ESRD patients. However, one of the most important complications that lead to transplant failure is graft rejection. It is already known that the pathophysiology of the rejection is immune response. Recent evidence showed that regulatory T cell (Treg) plays a central role in preventing graft rejection by inhibiting recipient alloimmune response (1-3). Characterization of Treg numbers and/or functional changes under various conditions may lead to a new preventive measure and/or a novel therapeutic strategy for graft rejection.

Kidney transplantation is conducted under general anesthesia. Interestingly, several agents used in general anesthesia have also modulated immune functions (4-12). Although the effect of inhalation anesthetic agents on leukocyte count has been shown, the effect on Treg function has totally been unknown. Knowing the effects of inhalation agents on Treg numbers and functions will be beneficial to intraoperative management during transplant surgery, aiming toward reducing the risk of graft rejection in the future.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients receiving 1st living donor kidney transplantation

Exclusion criteria

  • Hyperacute graft rejection
  • Pre-existing autoimmune or immunodeficiency diseases in recipients
  • Receiving blood product during 24-h perioperative period
  • Patient refuse to participate this study at any time point

Treatment and study plan

Sevoflurane

Drug

After induction of anesthesia and successful intubation, 2 L/min N2O, 2 L/min O2 , and 2% to 2.5% sevoflurane will be given for 10 minutes then total flow will be decreased to 2 L/min. Anesthesia will be maintained using 1-1.5 minimal alveolar concentration (MAC) of sevoflurane in 50% O2 and 50% N2O. Ventilation will be adjusted to keep end-tidal carbon dioxide 30-35 mmHg (Tidal volume 7-10 mL/kg).

Other names: Ultane

Desflurane

Drug

After induction of anesthesia and successful intubation, 2 L/min N2O, 2 L/min O2 , and 6% to 8% desflurane will be given for 10 minutes then total flow will be decreased to 2 L/min. Anesthesia will be maintained using 1-1.5 minimal alveolar concentration (MAC) of desflurane in 50% O2 and 50% N2O. Ventilation will be adjusted to keep end-tidal carbon dioxide 30-35 mmHg (Tidal volume 7-10 mL/kg).

Other names: Suprane

Primary outcomes

  1. Number of regulatory T cells

    Time frame: Within 24-h peri-operative period

    Assessing change of Treg numbers by flow cytometry from baseline (before exposure to sevoflurane or desflurane) to after exposure to sevoflurane or desflurane for 2-h and 24-h

Secondary outcomes

  1. T lymphocyte cytokine production

    Time frame: Within 24-h peri-operative period

    Assessing change of T lymphocyte cytokine production using Multiplex immunoassay of interleukin (IL)-10, Tumor Necrosis Factor (TGF)-beta, IL-2, Interferon (IFN)-gamma, IL-4, IL-5, IL-13, from baseline (before exposure to sevoflurane or desflurane) to after exposure to sevoflurane or desflurane for 2-h and 24-h

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Effects of Sevoflurane and Desflurane Anesthesia on Regulatory T Cells in Patients Undergoing Living Donor Kidney Transplantation

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 24, 2015
Registry last updated
Jun 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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