Comparison of the Genotoxicity of Desflurane and Propofol

NCT ID: NCT05185167

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-17

Study Completion Date

2022-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate if the anesthetics propofol and desflurane can damage DNA according to comet essay in patients submitted to lumbar disc surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

It is expected that DNA damage information provide the possible genotoxic effects of inhalational and intravenous anesthetics and contribute to the establishment of strategies aimed at reducing the risks to exposed patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

DNA Damage Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Desflurane Group

Desflurane 1,0 minimum alveolar concentration will be administered during anesthesia maintenance

Group Type EXPERIMENTAL

Anesthetics, General Desflurane Maintenance

Intervention Type DRUG

Comparison of dna damage of desflurane maintenance with propofol maintenance according to comet analysis

Propofol Group

Propofol 6 mg//kg/hour will be administered during anesthesia maintenance

Group Type EXPERIMENTAL

Anesthetics, General Propofol Maintenance

Intervention Type DRUG

Comparison of dna damage of propofol maintenance with desflurane maintenance according to comet analysis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anesthetics, General Desflurane Maintenance

Comparison of dna damage of desflurane maintenance with propofol maintenance according to comet analysis

Intervention Type DRUG

Anesthetics, General Propofol Maintenance

Comparison of dna damage of propofol maintenance with desflurane maintenance according to comet analysis

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Exclusion Criteria

1. Patients with ASA physical status III or IV disease
2. Chronic systemic disease (diabetes mellitus,chronic pulmonary disorders, chronic kidney and liver disorders)
3. Smoking or alcohol consumption
4. Recently received radiation, chemotherapy
5. Malignancy
6. Patients who will receive blood transfusion during the operation
7. Users of antioxidant supplements
8. Patients who have received general anesthesia in the last three months
9. Patients with known occupational exposures (operating room personnel, chemical plant worker
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Muğla Sıtkı Koçman University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Melike Korkmaz Toker

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Melike Korkmaz Toker, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Mugla Sıtkı Kocman University Department of Anesthesiology and reanimation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mugla Sitki Kocman University

Muğla, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Toker MK, Altiparmak B, Gursoy G, Uysal AI, Dede G, Gundogdu G, Dodurga Y, Ugur B. Comparison of the genotoxicity of propofol and desflurane using the comet assay in the lymphocytes of patients who underwent lumbar discectomy: A randomized trial. Saudi Med J. 2024 May;45(5):468-475. doi: 10.15537/smj.2024.45.5.20240077.

Reference Type DERIVED
PMID: 38734439 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MSKU 05/III

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.