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

NCT01870011 | Completed Phase 4

• 1 other identifier: 4-2013-0208
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Keywords

Propofol, renal protection, kidney transplantation

Outcome Measures

Primary Outcomes (1)

• The difference in inflammatory markers of recipients between groups during and after renal transplantation (CRP, WBC differential count, IL-6, TGF-β)

  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

  Inflammatory markers are evelauted immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction

Secondary Outcomes (1)

• 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

Other Outcomes (1)

• The difference in global oxidative stress markers of recipients between groups during and after renal transplantation (Free Oxygen Radicals Testing, Free Oxygen Radial Defense)

  changes of Global oxidative stress markers from Immediately after anesthesia induction to 2 hours after reperfusion

Study Arms (2)

Desflurane balanced anesthesia group

EXPERIMENTAL

Drug: Desflurane balanced anesthesia

Propofol total intravenous anesthesia group

ACTIVE COMPARATOR

Drug: Propofol total intravenous anesthesia

Interventions

Desflurane balanced anesthesia DRUG

Desflurane balanced anesthesia induced with thiopental sodium, remifentanil and atracurium and maintained with remifentanil target controlled infusion and desflurane inhalation

Desflurane balanced anesthesia group

Propofol total intravenous anesthesia DRUG

Propofol total intravenous anesthesia induced with propofol, remifentanil and atracurium and maintained with remifentanil and propofol target controlled infusion

Propofol total intravenous anesthesia group

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• (1) Refusal of legal guardian
• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 5, 2013
• Study Start: December 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 17, 2016

Record last verified: 2016-08

Locations

KR (1)