NCT01638624

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 12, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

June 13, 2016

Status Verified

July 1, 2012

Enrollment Period

4 months

First QC Date

July 3, 2012

Last Update Submit

June 10, 2016

Conditions

Total Knee ArthroplastyTourniquet-Induced Ischemia-Reperfusion Injury

Keywords

Propofolantioxidant capacitytotal knee arthroplastyPropofol,antioxidant

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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

Drug: Propofol

Control group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

PropofolDRUG

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

Propofol
PlaceboDRUG
Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ankara, 06110, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Derya Özkan, MD

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

    PRINCIPAL INVESTIGATOR

  • 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 CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant MD of Anesthesiology Department

Study Record Dates

First Submitted

July 3, 2012

First Posted

July 12, 2012

Study Start

June 1, 2012

Primary Completion

October 1, 2012

Study Completion

November 1, 2012

Last Updated

June 13, 2016

Record last verified: 2012-07

Locations

TU(1)