DNA DamageNCT05185167
Comparison of the Genotoxicity of Desflurane and Propofol
A study testing Anesthetics, General Desflurane Maintenance and Anesthetics, General Propofol Maintenance in people with DNA Damage and Anesthesia, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- DNA Damage, Anesthesia
- What is being tested?
- Anesthetics, General Desflurane Maintenance and Anesthetics, General Propofol Maintenance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jan 2022to 20 Mar 2022
- Phase
- Interventional
- 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
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
Who cannot join
- Patients with ASA physical status III or IV disease
- Chronic systemic disease (diabetes mellitus,chronic pulmonary disorders, chronic kidney and liver disorders)
- Smoking or alcohol consumption
- Recently received radiation, chemotherapy
- Malignancy
- Patients who will receive blood transfusion during the operation
Show all 9Show fewer
- Users of antioxidant supplements
- Patients who have received general anesthesia in the last three months
- Patients with known occupational exposures (operating room personnel, chemical plant worker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genotoxic Effects of Desflurane and Propofol Anesthesia in Patients Undergoing Lumbar Disc Surgery
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.
Read the detailed description
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
- DNA Damage, Anesthesia
- Being tested
- Anesthetics, General Desflurane Maintenance, Anesthetics, General Propofol Maintenance
- Keywords
- Desflurane, Intravenous anesthetics, propofol, comet essay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthetics, General Desflurane MaintenanceDrug
Comparison of dna damage of desflurane maintenance with propofol maintenance according to comet analysis
Anesthetics, General Propofol MaintenanceDrug
Comparison of dna damage of propofol maintenance with desflurane maintenance according to comet analysis
| Study group | Role | What they receive |
|---|---|---|
| Desflurane Group | Experimental | Desflurane 1,0 minimum alveolar concentration will be administered during anesthesia maintenance Receives: Drug: Anesthetics, General Desflurane Maintenance |
| Propofol Group | Experimental | Propofol 6 mg//kg/hour will be administered during anesthesia maintenance Receives: Drug: Anesthetics, General Propofol Maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of the DNA tail detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
The blood samples that evaluate with comet analysis aim to detect the intensity of the DNA tail, and the tail greater, the greater the damage.
Measured: Before anesthesia induction
Intensity of the DNA tail detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
The blood samples that evaluate with comet analysis aim to detect the intensity of the DNA tail, and the tail greater, the greater the damage.
Measured: 2 hours after anesthesia induction
Intensity of the DNA tail detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
The blood samples that evaluate with comet analysis aim to detect the intensity of the DNA tail, and the tail greater, the greater the damage.
Measured: postoperative 1st day
Intensity of the DNA tail detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
The blood samples that evaluate with comet analysis aim to detect the intensity of the DNA tail, and the tail greater, the greater the damage.
Measured: postoperative 5th day
Head length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
The blood samples that evaluate with comet analysis aim to detect the head length of DNA, the head greater, the smaller the damage.
Measured: Before anesthesia induction
Head length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
The blood samples that evaluate with comet analysis aim to detect the head length of DNA, the head greater, the smaller the damage.
Measured: 2 hours after anesthesia induction
Head length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
The blood samples that evaluate with comet analysis aim to detect the head length of DNA, the head greater, the smaller the damage.
Measured: postoperative 1 st day
Head length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
The blood samples that evaluate with comet analysis aim to detect the head length of DNA, the head greater, the smaller the damage.
Measured: postoperative 5th day
Tail length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
The blood samples that evaluate with comet analysis aim to detect the tail length of DNA, the head greater, the greater the damage.
Measured: before anesthesia induction
Tail length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
The blood samples that evaluate with comet analysis aim to detect the tail length of DNA, the head greater, the greater the damage.
Measured: 2 hours after anesthesia induction
Tail length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
The blood samples that evaluate with comet analysis aim to detect the tail length of DNA, the head greater, the greater the damage.
Measured: postoperative 1 st day
Tail length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
The blood samples that evaluate with comet analysis aim to detect the tail length of DNA, the head greater, the greater the damage.
Measured: postoperative 5th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start17 Jan 2022
- Primary completion15 Mar 2022
- Study completion20 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 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
- Investigators
- Melike Korkmaz Toker, Assoc. Prof., Principal investigator, Mugla Sıtkı Kocman University Department of Anesthesiology and reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185167
- Sponsor's protocol ID
- MSKU 05/III
- Status last verified
- Mar 2022
- First submitted
- 6 Dec 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38734439
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genotoxic Effects of Desflurane and Propofol Anesthesia in Patients Undergoing Lumbar Disc Surgery
- ClinicalTrials.gov ID
- NCT05185167
- Acronym / sponsor ID
- MSKU 05/III
- Conditions
- DNA Damage, Anesthesia
- Keywords
- Desflurane, Intravenous anesthetics, propofol, comet essay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 11 Jan 2022 (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 evaluate if the anesthetics propofol and desflurane can damage DNA according to comet essay in patients submitted to lumbar disc surgery.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desflurane Group | Experimental | Drug: Anesthetics, General Desflurane MaintenanceDesflurane 1,0 minimum alveolar concentration will be administered during anesthesia maintenance |
| Propofol Group | Experimental | Drug: Anesthetics, General Propofol MaintenancePropofol 6 mg//kg/hour will be administered during anesthesia maintenance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 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
Key exclusion criteria (9 listed)
- Patients with ASA physical status III or IV disease
- Chronic systemic disease (diabetes mellitus,chronic pulmonary disorders, chronic kidney and liver disorders)
- Smoking or alcohol consumption
- 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 |
|---|---|---|
| Anesthetics, General Desflurane MaintenanceComparison of dna damage of desflurane maintenance with propofol maintenance according to comet analysis | Drug | Desflurane Group |
| Anesthetics, General Propofol MaintenanceComparison of dna damage of propofol maintenance with desflurane maintenance according to comet analysis | Drug | Propofol Group |
Primary outcome
Intensity of the DNA tail detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
Time frame: Before anesthesia induction
The blood samples that evaluate with comet analysis aim to detect the intensity of the DNA tail, and the tail greater, the greater the damage.
Intensity of the DNA tail detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
Time frame: 2 hours after anesthesia induction
The blood samples that evaluate with comet analysis aim to detect the intensity of the DNA tail, and the tail greater, the greater the damage.
Intensity of the DNA tail detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
Time frame: postoperative 1st day
The blood samples that evaluate with comet analysis aim to detect the intensity of the DNA tail, and the tail greater, the greater the damage.
Intensity of the DNA tail detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
Time frame: postoperative 5th day
The blood samples that evaluate with comet analysis aim to detect the intensity of the DNA tail, and the tail greater, the greater the damage.
Head length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
Time frame: Before anesthesia induction
The blood samples that evaluate with comet analysis aim to detect the head length of DNA, the head greater, the smaller the damage.
Head length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
Time frame: 2 hours after anesthesia induction
The blood samples that evaluate with comet analysis aim to detect the head length of DNA, the head greater, the smaller the damage.
Head length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
Time frame: postoperative 1 st day
The blood samples that evaluate with comet analysis aim to detect the head length of DNA, the head greater, the smaller the damage.
Head length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
Time frame: postoperative 5th day
The blood samples that evaluate with comet analysis aim to detect the head length of DNA, the head greater, the smaller the damage.
Tail length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
Time frame: before anesthesia induction
The blood samples that evaluate with comet analysis aim to detect the tail length of DNA, the head greater, the greater the damage.
Tail length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
Time frame: 2 hours after anesthesia induction
The blood samples that evaluate with comet analysis aim to detect the tail length of DNA, the head greater, the greater the damage.
Tail length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
Time frame: postoperative 1 st day
The blood samples that evaluate with comet analysis aim to detect the tail length of DNA, the head greater, the greater the damage.
Tail length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire
Time frame: postoperative 5th day
The blood samples that evaluate with comet analysis aim to detect the tail length of DNA, the head greater, the greater the damage.
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 31 Mar 2022.
- Derived from this study: PubMed 38734439Toker 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.
- Individual participant dataSharing planned: No
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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.
Melike Korkmaz Toker, Assoc. Prof. principal investigator
Mugla Sıtkı Kocman University Department of Anesthesiology and reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anesthetics, General Desflurane Maintenance and Anesthetics, General Propofol Maintenance in people with DNA Damage and Anesthesia, 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 3 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 31 Mar 2022. 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?
Intensity of the DNA tail detected by using Comet Assay IV Version 4.3.2 for Basler FireWire (time frame: Before anesthesia induction). The study lists 12 primary outcomes in all. 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 NCT05185167, which also lists 1 linked publication.
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 31 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.