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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05111717
Other study ID # MSKU 02/VII
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 17, 2021
Est. completion date December 30, 2021

Study information

Verified date March 2023
Source Mugla Sitki Koçman University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 30, 2021
Est. primary completion date December 25, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Ability to understand and willingness to sign an informed consent form 2. Elective lumbar spinal surgery that will take at least 120 minutes, 3. American Society of Anesthesiologists (ASA) physical status I and II 4. Be between the ages of 18 and 65 Exclusion Criteria: 1. Patients with ASA physical status III or IV disease 2. Smoking or alcohol consumption 3. Chronic systemic disease (diabetes mellitus,chronic pulmonary disorders, chronic kidney and liver disorders 4. recently received radiation, chemotherapy 5. malignancy 6. blood transfusion in operation 7. use of antioxidant supplements 8. have received general anesthesia in the last three months 9. Patients with known occupational exposures (operating room personnel, chemical plant workers

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Desflurane
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.

Locations

Country Name City State
Turkey Mugla Sitki Kocman University Training and research Hospital Mugla

Sponsors (1)

Lead Sponsor Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Bilban 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. — View Citation

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. — View Citation

Jaloszynski 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 5 minutes before induction of anesthesia ,120 minutes after the beginning of anesthesia
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