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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01132157
• Other study ID #: 4-2009-0598
• Status: Completed
• Phase: Phase 4
• First received: May 24, 2010
• Last updated: March 4, 2014
• Start date: March 2010
• Est. completion date: January 2012

Study information

• Verified date: March 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• End Stage Renal Disease
• Healthy
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 hour after surgery	No
Primary	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.	1 hour after surgery	No
Primary	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.	1 hour after surgery	No
Primary	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.	1 hour after surgery	No