DNA DamageNCT05111717
The Effect of Desfluran On Global Dna Methylation
An observational study of DNA Damage, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to demonstrate the molecular effect of desflurane on DNA by measuring the global DNA methylation level in patients under going lumbar spinal stenosis surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- DNA Damage
- What is being tested?
- Desflurane
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Nov 2021to 30 Dec 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with physical status I and II of the American Society of Anesthesiologists (ASA), aged between 18-65 and scheduled for lumbar spinal surgery, which will take at least 120 minutes, will be included in the study
Who may be able to join
- Ability to understand and willingness to sign an informed consent form
- Elective lumbar spinal surgery that will take at least 120 minutes,
- American Society of Anesthesiologists (ASA) physical status I and II
- Be between the ages of 18 and 65
Who cannot join
- Patients with ASA physical status III or IV disease
- Smoking or alcohol consumption
- Chronic systemic disease (diabetes mellitus,chronic pulmonary disorders, chronic kidney and liver disorders
- recently received radiation, chemotherapy
- malignancy
- blood transfusion in operation
Show all 9Show fewer
- use of antioxidant supplements
- have received general anesthesia in the last three months
- Patients with known occupational exposures (operating room personnel, chemical plant workers
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mugla Sıtkı Kocman University Training and research Hospital
Muğla
About this study
Official title: The Effect of Desfluran Administered in General Anesthesia On Global Dna Methylation
The purpose of this study is to demonstrate the molecular effect of desflurane on DNA by measuring the global DNA methylation level in patients under going lumbar spinal stenosis surgery under general anesthesia.
Read the detailed description
Forty patients scheduled for lumbar spinal surgery will include in the study. Peripheral venous blood samples will collect prior to the induction of anesthesia (T1) and after 120 minutes (T2). Anesthesia will maintaine with 40%-60% O2-air mixture and 6% desflurane. DNA will obtain from blood samples with the help of DNA isolation kit and global DNA methylation analysis will perform by ELISA method.
- Conditions
- DNA Damage
- Being tested
- Desflurane
- Keywords
- Desflurane,, DNA methylation, epigenetics, inhalation anesthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Peripheral venous blood samplesof patients will collected at two time points as follows: before the premedication and the induction of anesthesia (T₁): 120 minutes after the beginning of anesthesia (T₂). Anesthesia maintenance will be provided with 40% O₂ and minimum alveolar concentration (MAC) in 60% air with 6% desflurane. DNA will be obtained from blood samples with the help of DNA isolation kit, and global DNA methylation analysis will performed by ELISA method.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Peripheral venous blood samples will collected at two time points as follows: before the premedication and the induction of anesthesia (T₁): 120 minutes after the beginning of anesthesia (T₂). DNA will be obtained from blood samples , and global DNA methylation analysis will be done. Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global DNA methylation change 5 minutes before and 120 minutes after anesthesia induction in peripheral blood mononuclear cells
The global DNA methylation level will be measured 5 minutes before and 120 minutes after anesthesia induction.
Measured: 5 minutes before induction of anesthesia ,120 minutes after the beginning of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start17 Nov 2021
- Primary completion25 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DNA DamageStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melike Korkmaz Toker, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111717
- Sponsor's protocol ID
- MSKU 02/VII
- Status last verified
- Mar 2023
- First submitted
- 17 Oct 2021
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: via mail
Publications
Chowdhury B, Cho IH, Irudayaraj J. Technical advances in global DNA methylation analysis in human cancers. J Biol Eng. 2017 Mar 1;11:10. doi: 10.1186/s13036-017-0052-9. eCollection 2017.
PubMed 28261325Jaloszynski P, Kujawski M, Wasowicz M, Szulc R, Szyfter K. Genotoxicity of inhalation anesthetics halothane and isoflurane in human lymphocytes studied in vitro using the comet assay. Mutat Res. 1999 Feb 19;439(2):199-206. doi: 10.1016/s1383-5718(98)00195-8.
PubMed 10023059Bilban M, Jakopin CB, Ogrinc D. Cytogenetic tests performed on operating room personnel (the use of anaesthetic gases). Int Arch Occup Environ Health. 2005 Feb;78(1):60-4. doi: 10.1007/s00420-004-0579-1. Epub 2005 Feb 10.
PubMed 15703947
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Desfluran Administered in General Anesthesia On Global Dna Methylation
- ClinicalTrials.gov ID
- NCT05111717
- Acronym / sponsor ID
- MSKU 02/VII
- Conditions
- DNA Damage
- Keywords
- Desflurane,, DNA methylation, epigenetics, inhalation anesthetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 25 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 8 Nov 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 purpose of this study is to demonstrate the molecular effect of desflurane on DNA by measuring the global DNA methylation level in patients under going lumbar spinal stenosis surgery under general anesthesia.
Detailed description
Forty patients scheduled for lumbar spinal surgery will include in the study. Peripheral venous blood samples will collect prior to the induction of anesthesia (T1) and after 120 minutes (T2). Anesthesia will maintaine with 40%-60% O2-air mixture and 6% desflurane. DNA will obtain from blood samples with the help of DNA isolation kit and global DNA methylation analysis will perform by ELISA method.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Drug: DesfluranePeripheral venous blood samples will collected at two time points as follows: before the premedication and the induction of anesthesia (T₁): 120 minutes after the beginning of anesthesia (T₂). DNA will be obtained from blood samples , and global DNA methylation analysis will be done. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with physical status I and II of the American Society of Anesthesiologists (ASA), aged between 18-65 and scheduled for lumbar spinal surgery, which will take at least 120 minutes, will be included in the study
Key inclusion criteria (4 listed)
- Ability to understand and willingness to sign an informed consent form
- Elective lumbar spinal surgery that will take at least 120 minutes,
- American Society of Anesthesiologists (ASA) physical status I and II
- Be between the ages of 18 and 65
Key exclusion criteria (9 listed)
- Patients with ASA physical status III or IV disease
- Smoking or alcohol consumption
- Chronic systemic disease (diabetes mellitus,chronic pulmonary disorders, chronic kidney and liver disorders
- recently received radiation, chemotherapy
- malignancy
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 |
|---|---|---|
| DesfluranePeripheral venous blood samplesof patients will collected at two time points as follows: before the premedication and the induction of anesthesia (T₁): 120 minutes after the beginning of anesthesia (T₂). Anesthesia maintenance will be provided with 40% O₂ and minimum alveolar concentration (MAC) in 60% air with 6% desflurane. DNA will be obtained from blood samples with the help of DNA isolation kit, and global DNA methylation analysis will performed by ELISA method. | Drug | group 1 |
Primary outcome
Global DNA methylation change 5 minutes before and 120 minutes after anesthesia induction in peripheral blood mononuclear cells
Time frame: 5 minutes before induction of anesthesia ,120 minutes after the beginning of anesthesia
The global DNA methylation level will be measured 5 minutes before and 120 minutes after anesthesia induction.
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 15 Mar 2023.
- Background: PubMed 28261325Chowdhury B, Cho IH, Irudayaraj J. Technical advances in global DNA methylation analysis in human cancers. J Biol Eng. 2017 Mar 1;11:10. doi: 10.1186/s13036-017-0052-9. eCollection 2017.
- Background: PubMed 10023059Jaloszynski P, Kujawski M, Wasowicz M, Szulc R, Szyfter K. Genotoxicity of inhalation anesthetics halothane and isoflurane in human lymphocytes studied in vitro using the comet assay. Mutat Res. 1999 Feb 19;439(2):199-206. doi: 10.1016/s1383-5718(98)00195-8.
- Background: PubMed 15703947Bilban M, Jakopin CB, Ogrinc D. Cytogenetic tests performed on operating room personnel (the use of anaesthetic gases). Int Arch Occup Environ Health. 2005 Feb;78(1):60-4. doi: 10.1007/s00420-004-0579-1. Epub 2005 Feb 10.
- Individual participant dataSharing planned: No. via mail
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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 DNA Damage, run by Muğla Sıtkı Koçman University 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 4 inclusion and 9 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 15 Mar 2023. 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?
Global DNA methylation change 5 minutes before and 120 minutes after anesthesia induction in peripheral blood mononuclear cells (time frame: 5 minutes before induction of anesthesia ,120 minutes after the beginning of anesthesia). 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 NCT05111717, which also lists 3 linked publications.
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 15 Mar 2023.