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

Phase 4

Completed

• Conditions: End Stage Renal Disease
• Interventions: Drug: Propofol total intravenous anesthesia; Drug: Desflurane balanced anesthesia

• Registration Number: NCT01870011
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2013-05-30
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-06-05
• Study Start: 2013-12
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Adult deceased brain dead kidney donors and recipients scheduled for renal transplantation

Read More

Exclusion Criteria

1. Donor exclusion criteria:

(1) Refusal of legal guardian

2. Recipient exclusion criteria:

3. Patient refusal

4. Hypersensitivity to propofol, soybeans or peanuts

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

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

7. Congestive heart failure (NYHA III-IV)

8. Autoimmune disease patients

9. BMI over 30 kg/m2

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol total intravenous anesthesia group	Propofol total intravenous anesthesia	-
Desflurane balanced anesthesia group	Desflurane balanced anesthesia	-

Primary Outcome Measures

Name	Time	Method
The difference in inflammatory markers of recipients between groups during and after renal transplantation (CRP, WBC differential count, IL-6, TGF-β)	Inflammatory markers are evelauted immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction	1. Kidney donor: Inflammatory markers are evaluated immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction; 2. 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

Name	Time	Method
The difference in renal function of kidney recipients between groups after renal transplantation (BUN/Cr, cystatin C, NGAL)	immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction	1. Kidney donor: Inflammatory markers are evaluated immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction; 2. 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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of