The Effect of Propofol Infusion on Total Antioxidant Status During Tourniquet-Induced Ischemia-Reperfusion Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Diskapi Teaching and Research Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
derya özkan, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT01638624
First received: July 3, 2012
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

The release of tourniquet produces reactive oxygen species which can cause injury. Propofol is chemically similar to phenol-based free radical scavengers.

Plasma total antioxidant capacity is a well-established marker of the overall protective effect of antioxidants in body fluids.The aim of the study is to investigate the effects of propofol on ischemia-reperfusion injury in total knee arthroplasty (TKA).


Condition Intervention Phase
Total Knee Arthroplasty
Tourniquet-Induced Ischemia-Reperfusion Injury
Drug: Propofol
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Propofol Infusion on Total Antioxidant Status During Tourniquet-Induced Ischemia-Reperfusion Injury in Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Diskapi Teaching and Research Hospital:

Primary Outcome Measures:
  • The perioperative alternation of the venous blood total antioxidant capacity levels of the arms [ Time Frame: T1,T2,T3 ] [ Designated as safety issue: Yes ]
    T1 : Before the spinal anesthesia performed T2 : At 30th min of tourniquet inflation T3 : At 2nd hours of tourniquet deflation


Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Propofol
Propofol infusion group: Under spinal anesthesia, a continuous intravenous infusion (2mg/kg/h) of propofol will be use during the operation
Drug: Propofol
Propofol :Propofol is an anesthetic agent, has structure similar to that of known such as alfa tocopherol.
Placebo Comparator: Control group
Placebo group: Under spinal anesthesia, a continuous intravenous infusion of volume-equivalent placebo will use during the operation
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-II physical status
  • Unilateral total knee arthroplasty
  • Age 18 years to 65 years

Exclusion Criteria:

  • Severe central nervous system disorders
  • Severe cardiopulmonary,renal,metabolic, or hepatic disease,
  • Blood volume deficits,
  • Coagulopathy,
  • Allergy to local anesthetics,
  • Peripheral neuropathies,
  • Body mass index > 35,
  • History of antioxidant drug use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01638624

Contacts
Contact: Derya Özkan, MD +903125962553 derya_z@yahoo.com

Locations
Turkey
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Anesthesiology and Biochemistry Clinics Recruiting
Ankara, Turkey, 06110
Contact: Derya Özkan, MD    +903125962553    derya_z@yahoo.com   
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Investigators
Principal Investigator: Derya Özkan, MD Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Anesthesiology Clinic
Study Chair: Taylan Akkaya, MD Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Anesthesiology Clinic
Study Chair: Ali Yalcindag, MD Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Biochemistry Clinic
Study Chair: Tuba Hanci, MD Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Biochemistry Clinic
Study Chair: Haluk Gümüs, MD Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Anesthesiology Clinic
Study Chair: Namik Delibas, MD Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Biochemistry Clinic
  More Information

No publications provided

Responsible Party: derya özkan, Consultant MD of Anesthesiology Department, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT01638624     History of Changes
Other Study ID Numbers: Diskapi2012
Study First Received: July 3, 2012
Last Updated: July 11, 2012
Health Authority: Turkey: Ethics Committee

Keywords provided by Diskapi Teaching and Research Hospital:
Propofol
antioxidant capacity
total knee arthroplasty
Propofol,antioxidant

Additional relevant MeSH terms:
Antioxidants
Ischemia
Reperfusion Injury
Wounds and Injuries
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Propofol
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Hypnotics and Sedatives
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 20, 2014