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

End Stage Renal Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870011
• Other study ID #: 4-2013-0208
• Status: Completed
• Phase: Phase 4
• First received: May 30, 2013
• Last updated: August 16, 2016
• Start date: December 2013
• Est. completion date: November 2014

Study information

• Verified date: August 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 69 Years

Eligibility

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:

1. Patient refusal

2. Hypersensitivity to propofol, soybeans or peanuts

3. History of vitamin C or E intake within 5 days before surgery

4. History of acute myocardial infarct within 6 months before surgery

5. Congestive heart failure (NYHA III-IV)

6. Autoimmune disease patients

7. BMI over 30 kg/m2

8. Left ventricular ejection fraction less than 35% upon preoperative echocardiography

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• Desflurane balanced anesthesia
Desflurane balanced anesthesia induced with thiopental sodium, remifentanil and atracurium and maintained with remifentanil target controlled infusion and desflurane inhalation
• Propofol total intravenous anesthesia
Propofol total intravenous anesthesia induced with propofol, remifentanil and atracurium and maintained with remifentanil and propofol target controlled infusion

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, 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
Other	The difference in global oxidative stress markers of recipients between groups during and after renal transplantation (Free Oxygen Radicals Testing, Free Oxygen Radial Defense)	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	changes of Global oxidative stress markers from Immediately after anesthesia induction to 2 hours after reperfusion	No
Primary	The difference in inflammatory markers of recipients between groups during and after renal transplantation (CRP, WBC differential count, IL-6, TGF-ß)	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	Inflammatory markers are evelauted immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction	No
Secondary	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	immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction	No