The Effect of Desfluran On Global Dna Methylation

NCT05111717 | Completed FDA Drug

• 1 other identifier: MSKU 02/VII
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

DNA Damage

Keywords

Desflurane,; DNA methylation; epigenetics; inhalation anesthetics

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Drug: Desflurane

Interventions

Desflurane DRUG

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.

group 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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
• use of antioxidant supplements
• have received general anesthesia in the last three months
• Patients with known occupational exposures (operating room personnel, chemical plant workers

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Mugla Sıtkı Kocman University Training and research Hospital

Muğla, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 28261325 BACKGROUND

• 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.

  PMID: 10023059 BACKGROUND

• 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.

  PMID: 15703947 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

peripheral venous blood sample

MeSH Terms

Interventions

Desflurane

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: November 8, 2021
• Study Start: November 17, 2021
• Primary Completion: December 25, 2021
• Study Completion: December 30, 2021
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)