Comparison of the Genotoxicity of Desflurane and Propofol

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: Completed
• Conditions: Anesthesia; DNA Damage
• Intervention / Treatment: Drug: Anesthetics, General Desflurane Maintenance; Drug: Anesthetics, General Propofol Maintenance

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: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	postoperative 5th day

Collaborators and Investigators

• Sponsor: Muğla Sıtkı Koçman University
• Investigators: Principal Investigator: Melike Korkmaz Toker, Assoc. Prof., Mugla Sıtkı Kocman University Department of Anesthesiology and Reanimation

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2022
• Primary Completion (Actual): March 15, 2022
• Study Completion (Actual): March 20, 2022

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Desflurane; propofol; Intravenous anesthetics; comet essay
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Hypnotics and Sedatives; Anesthetics, Inhalation; Anesthetics; Propofol; Desflurane; Anesthetics, General
• Other Study ID 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