Comparison of the Protective Effect of Desflurane and Propofol in Patients With Renal Transplantation

March 4, 2014 updated by: Yonsei University

The Comparison of Preconditioning Effect of Desflurane and Antiapoptotic Effect of Propofol in Patients With Kidney Transplantation

Ischemia/reperfusion (IR) injury is the major cause of early renal dysfunction and acute renal failure of the transplanted kidney after renal transplantation. In 1986, Murry et al. described the phenomenon "ischemic preconditioning". Also, it was reported that a few non-ischemic stimuli could provide cellular tolerance against major ischemia through a mechanism similar to ischemic preconditioning. In an animal study, 1 minimal alveolar concentration of volatile anesthetics - a clinically relevant concentration - was reported to have a protective effect against ischemia/reperfusion injury, the effect being variable between types of anesthetics. Also, there were somm reports that intravenous anesthetics such as propofol could reduce IR injury by decreasing oxidative stress and apoptosis.

By reducing the ischemia/reperfusion injury of the grafted kidney, the morbidity and mortality related to renal transplantation can be reduced as well. The objective of this study is to find out whether, according to the type of anesthetics (Desflurane vs. Propofol), there is a difference in the protective effect against ischemia/reperfusion injury of the grafted kidney in patients receiving renal transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 4

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Severance Hospital, Yonsei University College of Medicine

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy kidney donors and their recipients of renal transplantation.

Exclusion Criteria:

  • a donor that has any medical or surgical history,
  • a recipient that is scheduled to have any other surgery with renal transplantation surgery.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propofol group
Drug: Propofol
In Desflurane group, donors and their recipients will be anesthetized with desflurane and remifentanil. In contrast, in Propofol group, donors will be anesthetized with Propofol and remifentanil and recipients will be anesthetized with desflurane and remifentanil.
Active Comparator: Desflurane group
Drug: Desflurane
In Desflurane group, donors and their recipients will be anesthetized with desflurane and remifentanil. In contrast, in Propofol group, donors will be anesthetized with Propofol and remifentanil and recipients will be anesthetized with desflurane and remifentanil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BUN(Blood Urea Nitrogen)
Time Frame: 1 hour after surgery
The primary outcome of our study is to find out whether, according to donors' anesthetics (desflurane or propofol), there is a difference in grafted kidney function postoperatively.
1 hour after surgery
Cr density
Time Frame: 1 hour after surgery
The primary outcome of our study is to find out whether, according to donors' anesthetics (desflurane or propofol), there is a difference in grafted kidney function postoperatively.
1 hour after surgery
estimated GFR(Glomerular Filtration Ratio)
Time Frame: 1 hour after surgery
The primary outcome of our study is to find out whether, according to donors' anesthetics (desflurane or propofol), there is a difference in grafted kidney function postoperatively.
1 hour after surgery
urine output to check the the degree of protection for renal function
Time Frame: 1 hour after surgery
The primary outcome of our study is to find out whether, according to donors' anesthetics (desflurane or propofol), there is a difference in grafted kidney function postoperatively.
1 hour after surgery

Collaborators and Investigators

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

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Bon Nyeo Koo, MD, Ph.D, Severance Hospital, Yonsei University College of Medicine

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

March 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

May 24, 2010

First Submitted That Met QC Criteria

May 26, 2010

First Posted (Estimate)

May 27, 2010

Study Record Updates

Last Update Posted (Estimate)

March 5, 2014

Last Update Submitted That Met QC Criteria

March 4, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2009-0598

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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