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

Primary Purpose

Healthy, End Stage Renal Disease

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Desflurane

Propofol

About this trial

This is an interventional supportive care trial for Healthy focused on measuring Healthy Kidney Donors and Their Recipients with End Stage Renal Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Severance hospital, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Propofol group

Desflurane group

Arm Description

Outcomes

Primary Outcome Measures

BUN(Blood Urea Nitrogen)

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.

Cr density

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.

estimated GFR(Glomerular Filtration Ratio)

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.

urine output to check the the degree of protection for renal function

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01132157

First Posted

May 24, 2010

Last Updated

March 4, 2014

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01132157

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, End Stage Renal Disease

Keywords

Healthy Kidney Donors and Their Recipients with End Stage Renal Disease

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Propofol group

Arm Type

Experimental

Arm Title

Desflurane group

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Desflurane

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Propofol

Intervention Description

Primary Outcome Measure Information:

Title

BUN(Blood Urea Nitrogen)

Description

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.

Time Frame

1 hour after surgery

Title

Cr density

Description

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.

Time Frame

1 hour after surgery

Title

estimated GFR(Glomerular Filtration Ratio)

Description

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.

Time Frame

1 hour after surgery

Title

urine output to check the the degree of protection for renal function

Description

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.

Time Frame

1 hour after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bon Nyeo Koo, MD, Ph.D

Organizational Affiliation

Severance Hospital, Yonsei University College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Severance hospital, Yonsei University College of Medicine

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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