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

NCT ID: NCT01638624

Last Updated: 2016-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-11-30

Brief Summary

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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).

Detailed Description

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Conditions

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Total Knee Arthroplasty Tourniquet-Induced Ischemia-Reperfusion Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Propofol

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Propofol :Propofol is an anesthetic agent, has structure similar to that of known such as alfa tocopherol.

Control group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Propofol

Propofol :Propofol is an anesthetic agent, has structure similar to that of known such as alfa tocopherol.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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derya özkan

Consultant MD of Anesthesiology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Derya Özkan, MD

Role: PRINCIPAL_INVESTIGATOR

Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Anesthesiology Clinic

Taylan Akkaya, MD

Role: STUDY_CHAIR

Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Anesthesiology Clinic

Ali Yalcindag, MD

Role: STUDY_CHAIR

Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Biochemistry Clinic

Tuba Hanci, MD

Role: STUDY_CHAIR

Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Biochemistry Clinic

Haluk Gümüs, MD

Role: STUDY_CHAIR

Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Anesthesiology Clinic

Namik Delibas, MD

Role: STUDY_CHAIR

Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Biochemistry Clinic

Emel Gönen, Consultant

Role: STUDY_CHAIR

Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Orthopedics Clinic

Locations

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

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Diskapi2012

Identifier Type: -

Identifier Source: org_study_id

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