Comparison of the Protective Effect of Desflurane and Propofol in Patients With Renal Transplantation
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy End Stage Renal Disease |
Drug: Desflurane Drug: Propofol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | The Comparison of Preconditioning Effect of Desflurane and Antiapoptotic Effect of Propofol in Patients With Kidney Transplantation |
- BUN(Blood Urea Nitrogen) [ Time Frame: 1 hour after surgery ] [ Designated as safety issue: No ]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 [ Time Frame: 1 hour after surgery ] [ Designated as safety issue: No ]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) [ Time Frame: 1 hour after surgery ] [ Designated as safety issue: No ]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 [ Time Frame: 1 hour after surgery ] [ Designated as safety issue: No ]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 Enrollment: | 100 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Bon Nyeo Koo, MD, Ph.D | 82) 2-2228-2422 | koobn@yuhs.ac |
| Korea, Republic of | |
| Severance hospital, Yonsei University College of Medicine | Recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Contact: Bon Nyeo Koo, MD, Ph.D 82) 2-2228-2422 koobn@yuhs.ac | |
| Contact: Jae Hoon Lee | |
| Principal Investigator: | Bon Nyeo Koo, MD, Ph.D | Severance hospital, Yonsei University College of Medicine |
More Information
No publications provided
| Responsible Party: | Yonsei University |
| ClinicalTrials.gov Identifier: | NCT01132157 History of Changes |
| Other Study ID Numbers: | 4-2009-0598 |
| Study First Received: | May 24, 2010 |
| Last Updated: | February 1, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Yonsei University:
|
Healthy Kidney Donors and Their Recipients with End Stage Renal Disease |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency Propofol Desflurane Anesthetics, Intravenous Anesthetics, General |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Hypnotics and Sedatives Anesthetics, Inhalation |
ClinicalTrials.gov processed this record on June 18, 2013