NCT05185167

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

January 17, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

December 6, 2021

Last Update Submit

March 29, 2022

Conditions

DNA DamageAnesthesia

Keywords

DesfluraneIntravenous anestheticspropofolcomet essay

Outcome Measures

Primary Outcomes (12)

  • 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

Study Arms (2)

Desflurane Group

EXPERIMENTAL

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

Drug: Anesthetics, General Desflurane Maintenance

Propofol Group

EXPERIMENTAL

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

Drug: Anesthetics, General Propofol Maintenance

Interventions

Anesthetics, General Desflurane MaintenanceDRUG

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

Desflurane Group
Anesthetics, General Propofol MaintenanceDRUG

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

Propofol Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mugla Sitki Kocman University

Muğla, 48000, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 38734439DERIVED

MeSH Terms

Interventions

Anesthetics

Intervention Hierarchy (Ancestors)

Central Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Melike Korkmaz Toker, Assoc. Prof.

    Mugla Sıtkı Kocman University Department of Anesthesiology and reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 6, 2021

First Posted

January 11, 2022

Study Start

January 17, 2022

Primary Completion

March 15, 2022

Study Completion

March 20, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)