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

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638624
• Other study ID #: Diskapi2012
• Status: Completed
• Phase: Phase 4
• First received: July 3, 2012
• Last updated: June 10, 2016
• Start date: June 2012
• Est. completion date: November 2012

Study information

• Verified date: July 2012
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ischemia
• Reperfusion Injury
• Total Knee Arthroplasty
• Tourniquet-Induced Ischemia-Reperfusion Injury

Intervention

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

Locations

Country	Name	City	State
Turkey	Ministry of health Diskapi Yildirim Beyazit Training and Research Hospital Anesthesiology and Biochemistry Clinics	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes