Total Knee ArthroplastyPhase 4NCT01638624
The Effect of Propofol Infusion on Total Antioxidant Status During Tourniquet-Induced Ischemia-Reperfusion Injury
A Phase 4 study testing Propofol in people with Total Knee Arthroplasty and Tourniquet-Induced Ischemia-Reperfusion Injury, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty, Tourniquet-Induced Ischemia-Reperfusion Injury
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2012to Nov 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II physical status
- Unilateral total knee arthroplasty
- Age 18 years to 80 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Anesthesiology and Biochemistry Clinics
Ankara, 06110
About this study
Official title: 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).
- Being tested
- Propofol, Placebo
- Keywords
- Propofol, antioxidant capacity, total knee arthroplasty, Propofol,antioxidant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Propofol :Propofol is an anesthetic agent, has structure similar to that of known such as alfa tocopherol.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Propofol infusion group: Under spinal anesthesia, a continuous intravenous infusion (2mg/kg/h) of propofol will be use during the operation Receives: Drug: Propofol |
| Control group | Placebo comparator | Placebo group: Under spinal anesthesia, a continuous intravenous infusion of volume-equivalent placebo will use during the operation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: T1,T2,T3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, derya özkan, Diskapi Teaching and Research Hospital
- Investigators
- Derya Özkan, MD, Principal investigator, Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Anesthesiology ClinicTaylan Akkaya, MD, Study chair, Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Anesthesiology ClinicAli Yalcindag, MD, Study chair, Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Biochemistry ClinicTuba Hanci, MD, Study chair, Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Biochemistry ClinicHaluk Gümüs, MD, Study chair, Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Anesthesiology ClinicNamik Delibas, MD, Study chair, Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Biochemistry ClinicEmel Gönen, Consultant, Study chair, Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Orthopedics Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638624
- Sponsor's protocol ID
- Diskapi2012
- Status last verified
- Jul 2012
- First submitted
- 3 Jul 2012
- Last updated
- 13 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Propofol Infusion on Total Antioxidant Status During Tourniquet-Induced Ischemia-Reperfusion Injury in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01638624
- Acronym / sponsor ID
- Diskapi2012
- Keywords
- Propofol, antioxidant capacity, total knee arthroplasty, Propofol,antioxidant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 12 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: PropofolPropofol infusion group: Under spinal anesthesia, a continuous intravenous infusion (2mg/kg/h) of propofol will be use during the operation |
| Control group | Placebo comparator | Drug: PlaceboPlacebo group: Under spinal anesthesia, a continuous intravenous infusion of volume-equivalent placebo will use during the operation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-II physical status
- Unilateral total knee arthroplasty
- Age 18 years to 80 years
Key exclusion criteria (8 listed)
- Severe central nervous system disorders
- Severe cardiopulmonary,renal,metabolic, or hepatic disease,
- Blood volume deficits,
- Coagulopathy,
- Allergy to local anesthetics,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolPropofol :Propofol is an anesthetic agent, has structure similar to that of known such as alfa tocopherol. | Drug | Propofol |
| Placebo | Drug | Control group |
Primary outcome
The perioperative alternation of the venous blood total antioxidant capacity levels of the arms
Time frame: T1,T2,T3
T1 : Before the spinal anesthesia performed T2 : At 30th min of tourniquet inflation T3 : At 2nd hours of tourniquet deflation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derya Özkan, MD principal investigator
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Anesthesiology Clinic
Taylan Akkaya, MD study chair
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Anesthesiology Clinic
Ali Yalcindag, MD study chair
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Biochemistry Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol in people with Total Knee Arthroplasty and Tourniquet-Induced Ischemia-Reperfusion Injury, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The perioperative alternation of the venous blood total antioxidant capacity levels of the arms (time frame: T1,T2,T3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2016.