Back to resultsA Comparison of Propofol Based Total Intravenous Anesthesia and Desflurane Based Balanced Anesthesia on Renal Protection During Deceased Brain Dead Donor Kidney Transplantation - A Prospective, Randomized Trial
Primary Purpose
End Stage Renal Disease
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Desflurane balanced anesthesia
Propofol total intravenous anesthesia
Sponsored by
About this trial
This is an interventional prevention trial for End Stage Renal Disease focused on measuring Propofol, renal protection, kidney transplantation
Eligibility Criteria
Inclusion Criteria:
- Adult deceased brain dead kidney donors and recipients scheduled for renal transplantation
Exclusion Criteria:
1. Donor exclusion criteria:
(1) Refusal of legal guardian
2. Recipient exclusion criteria:
- Patient refusal
- Hypersensitivity to propofol, soybeans or peanuts
- History of vitamin C or E intake within 5 days before surgery
- History of acute myocardial infarct within 6 months before surgery
- Congestive heart failure (NYHA III-IV)
- Autoimmune disease patients
- BMI over 30 kg/m2
- Left ventricular ejection fraction less than 35% upon preoperative echocardiography
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Desflurane balanced anesthesia group
Propofol total intravenous anesthesia group
Arm Description
Outcomes
Primary Outcome Measures
The difference in inflammatory markers of recipients between groups during and after renal transplantation (CRP, WBC differential count, IL-6, TGF-β)
Kidney donor: Inflammatory markers are evaluated immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction
Kidney recipient:
(1) Inflammatory markers: Immediately after anesthesia induction, 2 and 24 hours after reperfusion (2) Renal function markers: Before anesthesia, 2 hours after reperfusion, immediate post-op, 24 and 48 hours postoperatively
Secondary Outcome Measures
The difference in renal function of kidney recipients between groups after renal transplantation (BUN/Cr, cystatin C, NGAL)
Kidney donor: Inflammatory markers are evaluated immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction
Kidney recipient:
(1) Inflammatory markers: Immediately after anesthesia induction, 2 and 24 hours after reperfusion (2) Renal function markers: Before anesthesia, 2 hours after reperfusion, immediate post-op, 24 and 48 hours postoperatively
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01870011
Brief Title
A Comparison of Propofol Based Total Intravenous Anesthesia and Desflurane Based Balanced Anesthesia on Renal Protection During Deceased Brain Dead Donor Kidney Transplantation - A Prospective, Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Renal ischemia/reperfusion (I/R)-induced injury is known to be associated with immediate and long-term kidney dysfunction after renal transplantation. Protecting the kidney against I/R injury and maintaining renal function during renal transplant surgery is therefore very important in order to improve post-operative outcome. This purpose of this study is to investigate whether propofol anesthesia done in both kidney donors and recipients during deceased brain dead donor kidney transplantation is effective in reducing renal I/R injury via its antioxidant and antiinflammatory properties and improve post-transplant outcome compared to desflurane anesthesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Propofol, renal protection, kidney transplantation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Desflurane balanced anesthesia group
Arm Type
Experimental
Arm Title
Propofol total intravenous anesthesia group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Desflurane balanced anesthesia
Intervention Description
Desflurane balanced anesthesia induced with thiopental sodium, remifentanil and atracurium and maintained with remifentanil target controlled infusion and desflurane inhalation
Intervention Type
Drug
Intervention Name(s)
Propofol total intravenous anesthesia
Intervention Description
Propofol total intravenous anesthesia induced with propofol, remifentanil and atracurium and maintained with remifentanil and propofol target controlled infusion
Primary Outcome Measure Information:
Title
The difference in inflammatory markers of recipients between groups during and after renal transplantation (CRP, WBC differential count, IL-6, TGF-β)
Description
Kidney donor: Inflammatory markers are evaluated immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction
Kidney recipient:
(1) Inflammatory markers: Immediately after anesthesia induction, 2 and 24 hours after reperfusion (2) Renal function markers: Before anesthesia, 2 hours after reperfusion, immediate post-op, 24 and 48 hours postoperatively
Time Frame
Inflammatory markers are evelauted immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction
Secondary Outcome Measure Information:
Title
The difference in renal function of kidney recipients between groups after renal transplantation (BUN/Cr, cystatin C, NGAL)
Description
Kidney donor: Inflammatory markers are evaluated immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction
Kidney recipient:
(1) Inflammatory markers: Immediately after anesthesia induction, 2 and 24 hours after reperfusion (2) Renal function markers: Before anesthesia, 2 hours after reperfusion, immediate post-op, 24 and 48 hours postoperatively
Time Frame
immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction
Other Pre-specified Outcome Measures:
Title
The difference in global oxidative stress markers of recipients between groups during and after renal transplantation (Free Oxygen Radicals Testing, Free Oxygen Radial Defense)
Description
Kidney donor: Inflammatory markers are evaluated immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction
Kidney recipient:
(1) Inflammatory markers: Immediately after anesthesia induction, 2 and 24 hours after reperfusion (2) Renal function markers: Before anesthesia, 2 hours after reperfusion, immediate post-op, 24 and 48 hours postoperatively
Time Frame
changes of Global oxidative stress markers from Immediately after anesthesia induction to 2 hours after reperfusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult deceased brain dead kidney donors and recipients scheduled for renal transplantation
Exclusion Criteria:
1. Donor exclusion criteria:
(1) Refusal of legal guardian
2. Recipient exclusion criteria:
Patient refusal
Hypersensitivity to propofol, soybeans or peanuts
History of vitamin C or E intake within 5 days before surgery
History of acute myocardial infarct within 6 months before surgery
Congestive heart failure (NYHA III-IV)
Autoimmune disease patients
BMI over 30 kg/m2
Left ventricular ejection fraction less than 35% upon preoperative echocardiography
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
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A Comparison of Propofol Based Total Intravenous Anesthesia and Desflurane Based Balanced Anesthesia on Renal Protection During Deceased Brain Dead Donor Kidney Transplantation - A Prospective, Randomized Trial
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