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

Primary Purpose

Inhalation Anesthesia, Lung Injury

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sevoflurane
Desflurane
Propofol
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Inhalation Anesthesia focused on measuring Sevoflurane, Desflurane, Clara cells protein

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • living liver donors

Exclusion Criteria:

  • smoking
  • under 18 years
  • over 65 years
  • Patients who refused written informed consent forms

Sites / Locations

  • Inonu University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Sevoflurane

Desflurane

Total intravenous anesthesia

Arm Description

Sevoflurane will use for anesthesia maintenance for liver donor hepatectomy surgery

Desflurane will use for anesthesia maintenance for liver donor hepatectomy surgery

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

Outcomes

Primary Outcome Measures

clara cell protein blood levels
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

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

Full Information

First Posted
November 3, 2020
Last Updated
November 11, 2021
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT04645316
Brief Title
The Effect of Sevoflurane and Desflurane on Clara Cell Protein on the Lung
Official Title
The Effect of Sevoflurane and Desflurane on Clara Cell Protein on the Lung in Liver Transplant Donors: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 25, 2020 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
June 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inhalation Anesthesia, Lung Injury
Keywords
Sevoflurane, Desflurane, Clara cells protein

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sevoflurane
Arm Type
Active Comparator
Arm Description
Sevoflurane will use for anesthesia maintenance for liver donor hepatectomy surgery
Arm Title
Desflurane
Arm Type
Active Comparator
Arm Description
Desflurane will use for anesthesia maintenance for liver donor hepatectomy surgery
Arm Title
Total intravenous anesthesia
Arm Type
Placebo Comparator
Arm Description
Total intravenous anesthesia (propofol/remifentanyl) will use for anesthesia maintenance for liver donor hepatectomy surgery
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Desflurane
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
TIVA(propofol-remifentanyl)
Intervention Description
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.
Primary Outcome Measure Information:
Title
clara cell protein blood levels
Description
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.
Time Frame
baseline,up to 6 hours
Secondary Outcome Measure Information:
Title
mean arterial pressure
Description
Mean arterial pressure will be measured at 30-minute intervals from the start of anesthesia induction to extubation.
Time Frame
Procedure (from beginning of anesthesia induction to extubation at 30-minute intervals)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: living liver donors Exclusion Criteria: smoking under 18 years over 65 years Patients who refused written informed consent forms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muharrem Ucar
Organizational Affiliation
Inonu University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inonu University
City
Malatya
ZIP/Postal Code
44250
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
11193758
Citation
Stripp BR, Reynolds SD, Plopper CG, Boe IM, Lund J. Pulmonary phenotype of CCSP/UG deficient mice: a consequence of CCSP deficiency or altered Clara cell function? Ann N Y Acad Sci. 2000;923:202-9. doi: 10.1111/j.1749-6632.2000.tb05531.x.
Results Reference
result

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

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