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

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ClinicalTrials.gov Identifier: NCT04645316
Recruitment Status : Completed
First Posted : November 27, 2020
Last Update Posted : November 12, 2021
Sponsor:
Information provided by (Responsible Party):
nureddin teker, Inonu University

Study Description
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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
Inhalation Anesthesia Lung Injury Drug: Sevoflurane Drug: Desflurane Drug: Propofol Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : November 25, 2020
Actual Primary Completion Date : June 15, 2021
Actual Study Completion Date : June 20, 2021

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Arms and Interventions
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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 Name: TIVA(propofol-remifentanyl)


Outcome Measures
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Primary Outcome Measures :
  1. clara cell protein blood levels [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • living liver donors

Exclusion Criteria:

  • smoking
  • under 18 years
  • over 65 years
  • Patients who refused written informed consent forms
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04645316


Locations
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Turkey
Inonu University
Malatya, Turkey, 44250
Sponsors and Collaborators
Inonu University
Investigators
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Principal Investigator: Muharrem Ucar Inonu University
More Information
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Publications of Results:

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Responsible Party: nureddin teker, Assistant doctor, Inonu University
ClinicalTrials.gov Identifier: NCT04645316    
Other Study ID Numbers: NTeker1
First Posted: November 27, 2020    Key Record Dates
Last Update Posted: November 12, 2021
Last Verified: March 2021

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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, Inonu University:
Sevoflurane
Desflurane
Clara cells protein
Additional relevant MeSH terms:
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Lung Injury
Respiratory Tract Diseases
Lung Diseases
Thoracic Injuries
Wounds and Injuries
Propofol
Sevoflurane
Desflurane
 Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation