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

Primary Purpose

Total Knee Arthroplasty, Tourniquet-Induced Ischemia-Reperfusion Injury

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Propofol
Placebo
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Total Knee Arthroplasty focused on measuring Propofol, antioxidant capacity, total knee arthroplasty, Propofol,antioxidant

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Anesthesiology and Biochemistry Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Propofol

Control group

Arm Description

Propofol infusion group: Under spinal anesthesia, a continuous intravenous infusion (2mg/kg/h) of propofol will be use during the operation

Placebo group: Under spinal anesthesia, a continuous intravenous infusion of volume-equivalent placebo will use during the operation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 3, 2012
Last Updated
June 10, 2016
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01638624
Brief Title
The Effect of Propofol Infusion on Total Antioxidant Status During Tourniquet-Induced Ischemia-Reperfusion Injury
Official Title
The Effect of Propofol Infusion on Total Antioxidant Status During Tourniquet-Induced Ischemia-Reperfusion Injury in Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty, Tourniquet-Induced Ischemia-Reperfusion Injury
Keywords
Propofol, antioxidant capacity, total knee arthroplasty, Propofol,antioxidant

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Propofol infusion group: Under spinal anesthesia, a continuous intravenous infusion (2mg/kg/h) of propofol will be use during the operation
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Placebo group: Under spinal anesthesia, a continuous intravenous infusion of volume-equivalent placebo will use during the operation
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Propofol :Propofol is an anesthetic agent, has structure similar to that of known such as alfa tocopherol.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The perioperative alternation of the venous blood total antioxidant capacity levels of the arms
Description
T1 : Before the spinal anesthesia performed T2 : At 30th min of tourniquet inflation T3 : At 2nd hours of tourniquet deflation
Time Frame
T1,T2,T3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derya Özkan, MD
Organizational Affiliation
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Anesthesiology Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Taylan Akkaya, MD
Organizational Affiliation
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Anesthesiology Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ali Yalcindag, MD
Organizational Affiliation
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Biochemistry Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tuba Hanci, MD
Organizational Affiliation
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Biochemistry Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Haluk Gümüs, MD
Organizational Affiliation
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Anesthesiology Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Namik Delibas, MD
Organizational Affiliation
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Biochemistry Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Emel Gönen, Consultant
Organizational Affiliation
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Orthopedics Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Anesthesiology and Biochemistry Clinics
City
Ankara
ZIP/Postal Code
06110
Country
Turkey

12. IPD Sharing Statement

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

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