Comparison of the Genotoxicity of Desflurane and Propofol

Sponsor
Muğla Sıtkı Koçman University (Other)
Overall Status
Completed
CT.gov ID
NCT05185167
Collaborator
(none)
30
1
2
2
14.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Anesthetics, General Desflurane Maintenance
  • Drug: Anesthetics, General Propofol Maintenance
N/A

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

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Genotoxic Effects of Desflurane and Propofol Anesthesia in Patients Undergoing Lumbar Disc Surgery
Actual Study Start Date :
Jan 17, 2022
Actual Primary Completion Date :
Mar 15, 2022
Actual Study Completion Date :
Mar 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Desflurane Group

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

Drug: Anesthetics, General Desflurane Maintenance
Comparison of dna damage of desflurane maintenance with propofol maintenance according to comet analysis

Experimental: Propofol Group

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

Drug: Anesthetics, General Propofol Maintenance
Comparison of dna damage of propofol maintenance with desflurane maintenance according to comet analysis

Outcome Measures

Primary Outcome Measures

  1. Intensity of the DNA tail detected by using Comet Assay IV Version 4.3.2 for Basler FireWire [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.

  2. Intensity of the DNA tail detected by using Comet Assay IV Version 4.3.2 for Basler FireWire [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.

  3. Intensity of the DNA tail detected by using Comet Assay IV Version 4.3.2 for Basler FireWire [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.

  4. Intensity of the DNA tail detected by using Comet Assay IV Version 4.3.2 for Basler FireWire [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.

  5. Head length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire [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.

  6. Head length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire [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.

  7. Head length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire [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.

  8. Head length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire [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.

  9. Tail length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire [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.

  10. Tail length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire [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.

  11. Tail length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire [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.

  12. Tail length of DNA detected by using Comet Assay IV Version 4.3.2 for Basler FireWire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mugla Sitki Kocman University Mugla Turkey 48000

Sponsors and Collaborators

  • Muğla Sıtkı Koçman University

Investigators

  • Principal Investigator: Melike Korkmaz Toker, Assoc. Prof., Mugla Sıtkı Kocman University Department of Anesthesiology and reanimation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Melike Korkmaz Toker, Associate Professor, Muğla Sıtkı Koçman University
ClinicalTrials.gov Identifier:
NCT05185167
Other Study ID Numbers:
  • MSKU 05/III
First Posted:
Jan 11, 2022
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Melike Korkmaz Toker, Associate Professor, Muğla Sıtkı Koçman University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022