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

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

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).

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty; Tourniquet-Induced Ischemia-Reperfusion Injury
• Intervention / Treatment: Drug: Placebo; Drug: Propofol

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06110
    • Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Anesthesiology and Biochemistry Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: July 3, 2012
• First Submitted That Met QC Criteria: July 11, 2012
• First Posted (Estimate): July 12, 2012

Study Record Updates

• Last Update Posted (Estimate): June 13, 2016
• Last Update Submitted That Met QC Criteria: June 10, 2016
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: total knee arthroplasty; Propofol; antioxidant capacity; Propofol,antioxidant
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Ischemia; Wounds and Injuries; Reperfusion Injury; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: Diskapi2012