The Effect of Sevoflurane and Desflurane on Clara Cell Protein on the Lung

Sponsor
Inonu University (Other)
Overall Status
Completed
CT.gov ID
NCT04645316
Collaborator
(none)
72
1
3
6.8
10.6

Study Details

Study Description

Brief Summary

Inhalation anesthesia; It means that the anesthetic drugs taken by the respiratory tract pass into the blood through the lung alveoli, reach the brain tissue, and create an anesthetic effect according to the density in the brain tissue. All inhalation anesthetics affect organ functions to varying degrees. Clara cell has been shown to have cell regeneration, immunomodulatory, anti-inflammatory and antioxidant activity in the bronchial epithelium. It is also thought that some substances accumulated in the respiratory system participate in the detoxification. Clara cell protein acts as a protein marker that indicates the severity of airway injuries after exposure to irritants. In this study, we planned to investigate the effect of inhalation anesthetics on Clara cell protein in liver transplant donors who will undergo hepatectomy surgery.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Inhalation anesthesia is still an important source of chemical hazard in the hospital environment due to its widespread use in operating rooms. Factors affecting the presence of anesthetic gases in the environment; device leakage, ventilation, fresh gas flow, and operation of the air cleaning system. Long-term exposure to anesthetic gases is known to adversely affect the health of employees in the operating room.

Clara cell plays a reliable role as a large bronchiolar progenitor cell that can contribute to cell regeneration in the bronchial epithelium. Thus, it contributes to the protection of the normal epithelium of the distal conductive airways. Additionally, it has been shown to have immunomodulatory, anti-inflammatory, and antioxidant activity. It is thought that some substances accumulated in the respiratory system participate in the detoxification.

Operations of patients undergoing hepatectomy usually take 4-6 hours. Inhalation anesthetics are widely used during this surgery. In this study, we thought to show the effect of long-term inhalation anesthesia exposure by performing this surgery on patients in this group. In this study, we aimed to investigate the effect of sevoflurane and desflurane inhalation anesthetics on clara cell protein in liver transplant donors scheduled for hepatectomy surgery.

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
The Effect of Sevoflurane and Desflurane on Clara Cell Protein on the Lung in Liver Transplant Donors: A Randomized Controlled Clinical Trial
Actual Study Start Date :
Nov 25, 2020
Actual Primary Completion Date :
Jun 15, 2021
Actual Study Completion Date :
Jun 20, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Sevoflurane

Sevoflurane will use for anesthesia maintenance for liver donor hepatectomy surgery

Drug: Sevoflurane
In the sevoflurane group (n = 25), after the induction of anesthesia with 2 mg / kg propofol and 1 µg / kg remifentanyl, rocuronium 0.6 mg / kg will be given for intubation. In this group, the Sevoflurane concentration will be adjusted between 1-2%, the BIS value will be 40-60, and it will be inhaled with an air / O2 mixture to be FiO2: 0.4.

Active Comparator: Desflurane

Desflurane will use for anesthesia maintenance for liver donor hepatectomy surgery

Drug: Desflurane
In the desflurane group (n = 25), after induction of anesthesia with 2 mg / kg propofol and 1 µg / kg remifentanyl, rocuronium 0.6 mg / kg will be given for intubation. In this group, Desflurane concentration will be adjusted between 6-8%, BIS value will be 40-60 and it will be inhaled with a mixture of air / O2 mixture to be FiO2: 0.4.

Placebo Comparator: Total intravenous anesthesia

Total intravenous anesthesia (propofol/remifentanyl) will use for anesthesia maintenance for liver donor hepatectomy surgery

Drug: Propofol
In the propofol-remifentanyl group (n = 25), rocuronium 0.6 mg / kg will be administered for intubation after 2 mg / kg propofol and 1 µg / kg remifentanil. Maintenance of anesthesia will be adjusted to be between 10 mg / kg / h for the first 10 minutes, 8 mg / kg / h for the following 10 minutes, and then by 6 mg / kg / h propofol infusion, with the BIS value between 40-60. Patients in this group will be inhaled with a mixture of air / O2 to be FiO2: 0.4. Inhalation anesthetics will not be used in this group.
Other Names:
  • TIVA(propofol-remifentanyl)
  • Outcome Measures

    Primary Outcome Measures

    1. clara cell protein blood levels [baseline,up to 6 hours]

      Hepatectomy surgery usually takes 4-6 hours. The clara cell protein levels (baseline) in the blood of the participants before surgery will be compared with the levels of clara cell protein in the blood that will be taken at the end of the surgery. The change between these levels will be measured by ELISA kit.

    Secondary Outcome Measures

    1. mean arterial pressure [Procedure (from beginning of anesthesia induction to extubation at 30-minute intervals)]

      Mean arterial pressure will be measured at 30-minute intervals from the start of anesthesia induction to extubation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • living liver donors
    Exclusion Criteria:
    • smoking

    • under 18 years

    • over 65 years

    • Patients who refused written informed consent forms

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Inonu University Malatya Turkey 44250

    Sponsors and Collaborators

    • Inonu University

    Investigators

    • Principal Investigator: Muharrem Ucar, Inonu University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    nureddin teker, Assistant doctor, Inonu University
    ClinicalTrials.gov Identifier:
    NCT04645316
    Other Study ID Numbers:
    • NTeker1
    First Posted:
    Nov 27, 2020
    Last Update Posted:
    Nov 12, 2021
    Last Verified:
    Mar 1, 2021
    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 nureddin teker, Assistant doctor, Inonu University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 12, 2021