Effects of Sevoflurane and Desflurane on Treg

June 14, 2017 updated by: Arpa Chutipongtanate, Mahidol University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Ramathibodi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sevoflurane
In sevoflurane arm (n=20) at the beginning after successful intubation, 2 L/min nitric oxide (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.
Drug: Sevoflurane
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
Experimental: Desflurane
In desflurane arm (n=20) at the beginning after 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 MAC of desflurane in 50% O2 and 50% N2O.
Drug: Desflurane
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 24-h peri-operative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 24-h peri-operative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Arpa Chutipongtanate, MD, Department of Anesthesia, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2015

Primary Completion (Actual)

June 3, 2017

Study Completion (Actual)

June 3, 2017

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimate)

September 24, 2015

Study Record Updates

Last Update Posted (Actual)

June 15, 2017

Last Update Submitted That Met QC Criteria

June 14, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-58-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data is obtained by flow cytometry and multiplex immunoassay. The data includes percentages of regulatory T cells and the measured cytokines. The data will be available in the end of study period, 05/2017.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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