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

The Effect of Sevoflurane and Desflurane on Clara Cell Protein on the Lung in Liver Transplant Donors: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Lung Injury; Inhalation Anesthesia
• Intervention / Treatment: Drug: Sevoflurane; Drug: Desflurane; Drug: Propofol

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Malatya, Turkey, 44250
    • Inonu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• living liver donors

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline,up to 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean arterial pressure	Mean arterial pressure will be measured at 30-minute intervals from the start of anesthesia induction to extubation.	Procedure (from beginning of anesthesia induction to extubation at 30-minute intervals)

Collaborators and Investigators

• Sponsor: Inonu University
• Investigators: Principal Investigator: Muharrem Ucar, Inonu University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2020
• Primary Completion (Actual): June 15, 2021
• Study Completion (Actual): June 20, 2021

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 12, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Desflurane; Sevoflurane; Clara cells protein
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Lung Injury; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Desflurane; Sevoflurane
• Other Study ID Numbers: NTeker1

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