IschemiaNCT02756715
The Effect of Anesthetics Agents on Vascular Injury and Level of Syndecan-1 During Knee Surgery
A study testing propofol group and Desflurane group in people with Ischemia, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
Ischeic reperfusion injury lead to a cellular dyfunction and increase in soluble glycocalyx of blood flow. syndecan-1 was a marker of glycocalyx. The purpose of this study is to prove the variation of level of serum syndecan-1 between preoperative and postoperative period. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ischemia
- What is being tested?
- propofol group and Desflurane group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 May 2016to 27 Feb 2020
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who was planned to undergo knee surgery.
Who cannot join
- age < 20 years old
- history of previous cancer
- history of previous peripheral vascular disease
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Ischeic reperfusion injury lead to a cellular dyfunction and increase in soluble glycocalyx of blood flow. syndecan-1 was a marker of glycocalyx.
The purpose of this study is to prove the variation of level of serum syndecan-1 between preoperative and postoperative period.
Read the detailed description
The patients were allocated randomly to receive propofol or desflurane. Also, a total of 6ml of blood sample was obtained for total 6 times in consecutive order.
- Preoperation (immediate before anesthesia induction)
- Immediate before tourniquet off
- 5 min after tourniquet off
- PACU
- postoperative 6 hours
- postoperative 24 hours
Serum in blood will be obtained and level of serum cytokine will be evaluated by enzyme-linked immunosorbent assay
- Conditions
- Ischemia
- Being tested
- propofol group, Desflurane group
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol groupDrug
Also called Propofol
Patient will be anesthetized by using propofol infusion during operation.
Desflurane groupDrug
Also called Desflurane
Patient will be anesthetized by using desflurane inhalation during operation.
| Study group | Role | What they receive |
|---|---|---|
| propofol group | Active comparator | The patient who anesthetized by using propofol. Receives: Drug: propofol group |
| Desflurane group | Active comparator | The patient who anesthetized by using sevoflurane. Receives: Drug: Desflurane group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Syndecan-1
change of level of syndecan-1 (scores range from 0 to 100)
Measured: Preoperative time, Immediate before tourniquet off,5 min after tourniquet off,PACU, postoperation after 6hours, postoperation after 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study start30 May 2016
- Primary completion26 Mar 2018
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IschemiaStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seong-Hyop Kim, Konkuk University Medical Center
- Investigators
- Seong-Hyop Kim, M.D,Ph.D, Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756715
- Sponsor's protocol ID
- KUH1160100
- Status last verified
- Feb 2020
- First submitted
- 28 Apr 2016
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Oh CS, Choi JM, Park EH, Piao L, Park HJ, Rhee KY, Kim SH. Impact of Anesthetic Agents on Endothelial Glycocalyx Injury during Total Knee Arthroplasty: Desflurane- vs. Propofol-Based Anesthesia-A Prospective Randomized Controlled Trial. Biomed Res Int. 2021 Jan 23;2021:8880267. doi: 10.1155/2021/8880267. eCollection 2021.
PubMed 33564684
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anesthetics Agents on Vascular Injury and Level of Syndecan-1 During Knee Surgery
- ClinicalTrials.gov ID
- NCT02756715
- Acronym / sponsor ID
- KUH1160100
- Conditions
- Ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 30 May 2016 (actual)
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 29 Apr 2016 (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.
Ischeic reperfusion injury lead to a cellular dyfunction and increase in soluble glycocalyx of blood flow. syndecan-1 was a marker of glycocalyx.
The purpose of this study is to prove the variation of level of serum syndecan-1 between preoperative and postoperative period.
Detailed description
The patients were allocated randomly to receive propofol or desflurane. Also, a total of 6ml of blood sample was obtained for total 6 times in consecutive order.
- Preoperation (immediate before anesthesia induction)
- Immediate before tourniquet off
- 5 min after tourniquet off
- PACU
- postoperative 6 hours
- postoperative 24 hours
Serum in blood will be obtained and level of serum cytokine will be evaluated by enzyme-linked immunosorbent assay
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol group | Active comparator | Drug: propofol groupThe patient who anesthetized by using propofol. |
| Desflurane group | Active comparator | Drug: Desflurane groupThe patient who anesthetized by using sevoflurane. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who was planned to undergo knee surgery.
Key exclusion criteria (4 listed)
- age < 20 years old
- history of previous cancer
- history of previous peripheral vascular disease
- Emergency surgery
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 |
|---|---|---|
| propofol groupAlso: PropofolPatient will be anesthetized by using propofol infusion during operation. | Drug | propofol group |
| Desflurane groupAlso: DesfluranePatient will be anesthetized by using desflurane inhalation during operation. | Drug | Desflurane group |
Primary outcome
Syndecan-1
Time frame: Preoperative time, Immediate before tourniquet off,5 min after tourniquet off,PACU, postoperation after 6hours, postoperation after 24hours
change of level of syndecan-1 (scores range from 0 to 100)
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 28 Feb 2020.
- Derived from this study: PubMed 33564684Oh CS, Choi JM, Park EH, Piao L, Park HJ, Rhee KY, Kim SH. Impact of Anesthetic Agents on Endothelial Glycocalyx Injury during Total Knee Arthroplasty: Desflurane- vs. Propofol-Based Anesthesia-A Prospective Randomized Controlled Trial. Biomed Res Int. 2021 Jan 23;2021:8880267. doi: 10.1155/2021/8880267. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Seong-Hyop Kim, M.D,Ph.D principal investigator
Konkuk University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propofol group and Desflurane group in people with Ischemia, run by Konkuk University Medical Center at 1 site in South Korea.
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 1 inclusion and 4 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 28 Feb 2020. 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Syndecan-1 (time frame: Preoperative time, Immediate before tourniquet off,5 min after tourniquet off,PACU, postoperation after 6hours, postoperation after 24hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02756715, which also lists 1 linked publication.
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 28 Feb 2020.