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

NCT04645316 | Completed

• 1 other identifier: NTeker1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Inhalation Anesthesia; Lung Injury

Keywords

Sevoflurane; Desflurane; Clara cells protein

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• mean arterial pressure

  Procedure (from beginning of anesthesia induction to extubation at 30-minute intervals)

Study Arms (3)

Sevoflurane

ACTIVE COMPARATOR

Sevoflurane will use for anesthesia maintenance for liver donor hepatectomy surgery

Drug: Sevoflurane

Desflurane

ACTIVE COMPARATOR

Desflurane will use for anesthesia maintenance for liver donor hepatectomy surgery

Drug: Desflurane

Total intravenous anesthesia

PLACEBO COMPARATOR

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

Drug: Propofol

Interventions

Sevoflurane DRUG

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.

Sevoflurane

Desflurane DRUG

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.

Desflurane

Propofol DRUG

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.

Also known as: TIVA(propofol-remifentanyl)

Total intravenous anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• living liver donors

You may not qualify if:

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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University

Malatya, 44250, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 11193758 RESULT

MeSH Terms

Conditions

Lung Injury

Interventions

Sevoflurane; Desflurane; Propofol

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Ethyl Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Muharrem Ucar

  Inonu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant doctor

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 27, 2020
• Study Start: November 25, 2020
• Primary Completion: June 15, 2021
• Study Completion: June 20, 2021
• Last Updated: November 12, 2021

Record last verified: 2021-03

Locations

TU (1)