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

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ClinicalTrials.gov Identifier: NCT01638624
Recruitment Status : Completed
First Posted : July 12, 2012
Last Update Posted : June 13, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Total Knee Arthroplasty Tourniquet-Induced Ischemia-Reperfusion Injury Drug: Propofol Drug: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : June 2012
Primary Completion Date : October 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-II physical status
  • Unilateral total knee arthroplasty
  • Age 18 years to 80 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638624


Locations
Turkey
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Anesthesiology and Biochemistry Clinics
Ankara, Turkey, 06110
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
Study Chair: Emel Gönen, Consultant Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Orthopedics Clinic
More Information

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
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: July 2012

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

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