Endothelial DysfunctionNCT05068336
Comparison of the Effects of Sevoflurane and Desflurane on Endothelial Glycocalyx
An observational study of Endothelial Dysfunction, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The glycocalyx is a dynamic and complex biochemical structure composed of proteoglycans, glycoproteins, and soluble proteins. The glycocalyx interacts with various proteins such as albumin and orosomucoid to form a thick surface layer on the vessel surface that is physiologically active. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- desflurane anesthesia and sevoflurane anesthesia
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2021to 4 Nov 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy volunteers
Who may be able to join
- Be in the 18-65 age rang
- Being in the ASA 1-3 risk group
- patients receiving general anesthesia
Who cannot join
- refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Sevoflurane and Desflurane on Endothelial Glycocalyx in Laparoscopic Hysterectomy Surgery
The glycocalyx is a dynamic and complex biochemical structure composed of proteoglycans, glycoproteins, and soluble proteins. The glycocalyx interacts with various proteins such as albumin and orosomucoid to form a thick surface layer on the vessel surface that is physiologically active. This is called the endothelial surface layer. This structure is constantly changing with the blood flowing in the vein. The glycocalyx regulates oncotic pressure and also prevents leukocyte and platelet adhesion to the endothelium. Endothelial cell dysfunction is a valuable marker of increased vascular permeability and impaired angiogenesis due to cardiovascular, thoracic, renal, and metabolic diseases.
Read the detailed description
The glycocalyx is a dynamic and complex biochemical structure composed of proteoglycans, glycoproteins, and soluble proteins. The glycocalyx interacts with various proteins such as albumin and orosomucoid to form a thick surface layer on the vessel surface that is physiologically active. This is called the endothelial surface layer. This structure is constantly changing with the blood flowing in the vein. The glycocalyx regulates oncotic pressure and also prevents leukocyte and platelet adhesion to the endothelium. Endothelial cell dysfunction is a valuable marker of increased vascular permeability and impaired angiogenesis due to cardiovascular, thoracic, renal, and metabolic diseases.
Some medical approaches, including anti-thrombin III, nitric oxide, the TNF-α analog etanercept, and inhalation agents, can repair or prevent deterioration of the endothelial glycocalyx. In a study by Chen et al., it was shown that Sevoflurane has a protective effect on syndecan and heparan sulfate, which are located in the glycocalyx structure, thus reducing leukocyte and platelet adhesion and protecting the vascular endothelium (8).
Kim et al. In a study conducted, it was shown that the protective effect of propofol, an intravenous anesthetic, on the vascular endothelium was greater than that of sevoflurane In our research, no study was found on the effect of another inhalation anesthetic, desflurane, on the vascular glycocalyx structure. In this study, we aimed to investigate and compare the effects of sevoflurane and desflurane on glycocalyx.
- Conditions
- Endothelial Dysfunction
- Being tested
- desflurane anesthesia, sevoflurane anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desflurane anesthesiaDiagnostic test
Anesthesia maintenance of the first group will be provided with desflurane, one of the inhalation anesthetics we routinely use. Before and after the operation, blood will be taken from the patients, and the blood will be centrifuged to evaluate the heparan sulfate and syndecan levels.
sevoflurane anesthesiaDiagnostic test
Anesthesia maintenance of the first group will be provided with sevoflurane, one of the inhalation anesthetics we routinely use. Before and after the operation, blood will be taken from the patients, and the blood will be centrifuged to evaluate the heparan sulfate and syndecan levels.
| Study group | Role | What they receive |
|---|---|---|
| desflurane | Anesthesia maintenance of the first group will be provided with desflurane, one of the inhalation anesthetics we routinely use. Before and after the operation, blood will be taken from the patients, and the blood will be centrifuged to evaluate the heparan sulfate and syndecan levels. Receives: Diagnostic Test: desflurane anesthesia | |
| sevoflurane | Anesthesia maintenance of the first group will be provided with sevoflurane, one of the inhalation anesthetics we routinely use. Before and after the operation, blood will be taken from the patients, and the blood will be centrifuged to evaluate the heparan sulfate and syndecan levels. Receives: Diagnostic Test: sevoflurane anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycocalyx components
The primary aim of the study was to measure the levels of heparan sulfate and syndecan, which are markers of endothelial glycocalyx structure, after the use of desflurane or sevoflurane. High biomarker levels are associated with impaired glycocalyx structure
Measured: the study will comlete in one month
Secondary outcomes (1)
haemodynamic changes
The secondary aim of the study is to compare the hemodynamic effects of sevoflurane and desflurane.
Measured: studdy will complete in one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start25 Aug 2021
- Primary completion25 Oct 2021
- Study completion4 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kocaeli Derince Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tahsin Şimşek, Kocaeli Derince Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068336
- Sponsor's protocol ID
- 514-192-32
- Status last verified
- Nov 2021
- First submitted
- 20 Aug 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Sevoflurane and Desflurane on Endothelial Glycocalyx in Laparoscopic Hysterectomy Surgery
- ClinicalTrials.gov ID
- NCT05068336
- Acronym / sponsor ID
- 514-192-32
- Conditions
- Endothelial Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kocaeli Derince Education and Research HospitalUniversity, hospital or other
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 4 Nov 2021 (actual)
- First posted
- 5 Oct 2021 (actual)
- 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 glycocalyx is a dynamic and complex biochemical structure composed of proteoglycans, glycoproteins, and soluble proteins. The glycocalyx interacts with various proteins such as albumin and orosomucoid to form a thick surface layer on the vessel surface that is physiologically active. This is called the endothelial surface layer. This structure is constantly changing with the blood flowing in the vein. The glycocalyx regulates oncotic pressure and also prevents leukocyte and platelet adhesion to the endothelium. Endothelial cell dysfunction is a valuable marker of increased vascular permeability and impaired angiogenesis due to cardiovascular, thoracic, renal, and metabolic diseases.
Detailed description
The glycocalyx is a dynamic and complex biochemical structure composed of proteoglycans, glycoproteins, and soluble proteins. The glycocalyx interacts with various proteins such as albumin and orosomucoid to form a thick surface layer on the vessel surface that is physiologically active. This is called the endothelial surface layer. This structure is constantly changing with the blood flowing in the vein. The glycocalyx regulates oncotic pressure and also prevents leukocyte and platelet adhesion to the endothelium. Endothelial cell dysfunction is a valuable marker of increased vascular permeability and impaired angiogenesis due to cardiovascular, thoracic, renal, and metabolic diseases.
Some medical approaches, including anti-thrombin III, nitric oxide, the TNF-α analog etanercept, and inhalation agents, can repair or prevent deterioration of the endothelial glycocalyx. In a study by Chen et al., it was shown that Sevoflurane has a protective effect on syndecan and heparan sulfate, which are located in the glycocalyx structure, thus reducing leukocyte and platelet adhesion and protecting the vascular endothelium (8).
Kim et al. In a study conducted, it was shown that the protective effect of propofol, an intravenous anesthetic, on the vascular endothelium was greater than that of sevoflurane In our research, no study was found on the effect of another inhalation anesthetic, desflurane, on the vascular glycocalyx structure. In this study, we aimed to investigate and compare the effects of sevoflurane and desflurane on glycocalyx.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| desflurane | – | Diagnostic Test: desflurane anesthesiaAnesthesia maintenance of the first group will be provided with desflurane, one of the inhalation anesthetics we routinely use. Before and after the operation, blood will be taken from the patients, and the blood will be centrifuged to evaluate the heparan sulfate and syndecan levels. |
| sevoflurane | – | Diagnostic Test: sevoflurane anesthesiaAnesthesia maintenance of the first group will be provided with sevoflurane, one of the inhalation anesthetics we routinely use. Before and after the operation, blood will be taken from the patients, and the blood will be centrifuged to evaluate the heparan sulfate and syndecan levels. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy volunteers
Key inclusion criteria (3 listed)
- Be in the 18-65 age rang
- Being in the ASA 1-3 risk group
- patients receiving general anesthesia
Key exclusion criteria (1 listed)
- refuse to participate in the study
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 |
|---|---|---|
| desflurane anesthesiaAnesthesia maintenance of the first group will be provided with desflurane, one of the inhalation anesthetics we routinely use. Before and after the operation, blood will be taken from the patients, and the blood will be centrifuged to evaluate the heparan sulfate and syndecan levels. | Diagnostic test | desflurane |
| sevoflurane anesthesiaAnesthesia maintenance of the first group will be provided with sevoflurane, one of the inhalation anesthetics we routinely use. Before and after the operation, blood will be taken from the patients, and the blood will be centrifuged to evaluate the heparan sulfate and syndecan levels. | Diagnostic test | sevoflurane |
Primary outcome
glycocalyx components
Time frame: the study will comlete in one month
The primary aim of the study was to measure the levels of heparan sulfate and syndecan, which are markers of endothelial glycocalyx structure, after the use of desflurane or sevoflurane. High biomarker levels are associated with impaired glycocalyx structure
1 secondary outcome
haemodynamic changes
Time frame: studdy will complete in one month
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 9 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endothelial Dysfunction, run by Kocaeli Derince Education 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 1 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 9 Nov 2021. 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. 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?
glycocalyx components (time frame: the study will comlete in one month). 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 9 Nov 2021.