Comparison of the Genotoxicity of Desflurane and Propofol

March 29, 2022 updated by: Melike Korkmaz Toker, Muğla Sıtkı Koçman University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Mugla, Turkey, 48000
        • Mugla Sitki Kocman University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Before anesthesia induction
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.
2 hours after anesthesia induction
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.
postoperative 1st day
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.
postoperative 5th day
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.
Before anesthesia induction
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.
2 hours after anesthesia induction
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.
postoperative 1 st day
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.
postoperative 5th day
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.
before anesthesia induction
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.
2 hours after anesthesia induction
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.
postoperative 1 st day
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.
postoperative 5th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Muğla Sıtkı Koçman University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Melike Korkmaz Toker, Assoc. Prof., Mugla Sıtkı Kocman University Department of Anesthesiology and Reanimation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MSKU 05/III

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings