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

August 16, 2016 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Desflurane balanced anesthesia group
Drug: Desflurane balanced anesthesia
Desflurane balanced anesthesia induced with thiopental sodium, remifentanil and atracurium and maintained with remifentanil target controlled infusion and desflurane inhalation
ACTIVE_COMPARATOR: Propofol total intravenous anesthesia group
Drug: Propofol total intravenous anesthesia
Propofol total intravenous anesthesia induced with propofol, remifentanil and atracurium and maintained with remifentanil and propofol target controlled infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in inflammatory markers of recipients between groups during and after renal transplantation (CRP, WBC differential count, IL-6, TGF-β)
Time Frame: 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
Inflammatory markers are evelauted immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in renal function of kidney recipients between groups after renal transplantation (BUN/Cr, cystatin C, NGAL)
Time Frame: 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
immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in global oxidative stress markers of recipients between groups during and after renal transplantation (Free Oxygen Radicals Testing, Free Oxygen Radial Defense)
Time Frame: changes of Global oxidative stress markers from Immediately after anesthesia induction to 2 hours after reperfusion
  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
changes of Global oxidative stress markers from Immediately after anesthesia induction to 2 hours after reperfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

May 30, 2013

First Submitted That Met QC Criteria

May 30, 2013

First Posted (ESTIMATE)

June 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2013-0208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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