Effect of Sevoflurane and Desflurane on Heme Oxygenase-1 Expression in Elective Cholecystectomy

NCT06457958 | Withdrawn Phase 4

• 1 other identifier: KSH-ANREA-BG-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

General anesthesia is routinely administered to patients who undergo elective cholecystectomy. The most commonly used inhalation agents during general anesthesia are sevoflurane and desflurane. Participants who will undergo elective cholecystectomy surgery and meet the eligibility criteria will be randomized. Participants will be divided into two groups. One group will receive sevoflurane, and the other group will receive desflurane. Preoperative and postoperative blood samples will be taken from the participants. After the sample collection process is completed, the ELISA method will be used for measuring blood heme oxygenase-1 protein levels, and the PCR technique will be used for measuring blood heme oxygenase-1 mRNA gene expression. The increase in amounts between the two groups will be compared. This study aims to demonstrate the effects of the most commonly used inhalation agents on the levels of heme oxygenase-1 enzyme, which has been shown to be an important enzyme in cellular protection mechanisms, as well as on mRNA gene expression, and to determine which agent may be more effective in preventing cellular damage at the molecular level.

Conditions

Cholecystitis, Chronic

Keywords

Anesthetics, Inhalation; Heme Oxygenase-1; Oxidative Stress; Sevoflurane; Desflurane; Anesthesia, General; Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Comparison of the Effects of Sevoflurane and Desflurane Inhalation Anesthetics on Blood Heme Oxygenase-1 Gene and Protein Levels

  The aim of this study is to compare the effects of sevoflurane and desflurane, commonly used inhalation anesthetics in routine anesthesia practice, on blood heme oxygenase-1 gene and protein levels.

  Postoperative at hour 1

Study Arms (2)

Sevoflurane Group

ACTIVE COMPARATOR

Patients in this group will receive sevoflurane as the anesthetic agent during elective cholecystectomy surgery. Sevoflurane is a commonly used inhalational anesthetic known for its rapid onset and recovery times.

Drug: Sevoflurane Group

Desflurane Group

ACTIVE COMPARATOR

Patients in this group will receive desflurane as the anesthetic agent during elective cholecystectomy surgery. Desflurane is another widely used inhalational anesthetic, notable for its low blood-gas solubility coefficient, leading to very rapid onset and recovery times.

Drug: Desflurane Group

Interventions

Sevoflurane Group DRUG

Preoperative: One hour before surgery, a blood sample will be taken. Intraoperative: Sevoflurane will be used as the inhalational anesthetic. Routine general anesthesia procedures will be followed. Sevoflurane consumption, oxygen levels, and vital parameters will be recorded. Postoperative: One hour after extubation, another blood sample will be taken, marking the end of patient monitoring. Laboratory Analysis: Blood samples will be stored in the biochemistry laboratory. Hemoxygenase-1 protein levels will be measured by ELISA, and mRNA expression will be analyzed using PCR.

Also known as: Sevoflurane maintenance anesthesia group

Sevoflurane Group

Desflurane Group DRUG

Preoperative: One hour before surgery, a blood sample will be taken. Intraoperative: Desflurane will be used as the inhalational anesthetic. Routine general anesthesia procedures will be followed. Desflurane consumption, oxygen levels, and vital parameters will be recorded. Postoperative: One hour after extubation, another blood sample will be taken, marking the end of patient monitoring. Laboratory Analysis: Blood samples will be stored in the biochemistry laboratory. Hemoxygenase-1 protein levels will be measured by ELISA, and mRNA expression will be analyzed using PCR.

Also known as: Desflurane maintenance anesthesia group

Desflurane Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing participants
• ASA class 1-2-3
• Ages 18-65 years
• Patients undergoing elective cholecystectomy surgery

You may not qualify if:

• Patients undergoing emergency cholecystectomy surgery
• Pregnant and postpartum patients
• Patients with a history of oncological diseases
• Patients with known genetic diseases
• Patients receiving total intravenous anesthesia
• Patients developing complications during surgery will be excluded

Sponsors & Collaborators

• Kocaeli City Hospital: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Kocaeli City Hospital

Kocaeli, IZMIT, 41100, Turkey (Türkiye)

Location

Related Publications (3)

• Bauer I, Raupach A. The Role of Heme Oxygenase-1 in Remote Ischemic and Anesthetic Organ Conditioning. Antioxidants (Basel). 2019 Sep 16;8(9):403. doi: 10.3390/antiox8090403.

  PMID: 31527528 BACKGROUND

• Wu ZF, Lin WL, Lee MS, Hung NK, Huang YS, Chen TW, Lu CH. Propofol vs desflurane on the cytokine, matrix metalloproteinase-9, and heme oxygenase-1 response during living donor liver transplantation: A pilot study. Medicine (Baltimore). 2019 Nov;98(48):e18244. doi: 10.1097/MD.0000000000018244.

  PMID: 31770287 BACKGROUND

• Hoetzel A, Schmidt R. Regulatory role of anesthetics on heme oxygenase-1. Curr Drug Targets. 2010 Dec;11(12):1495-503. doi: 10.2174/1389450111009011495.

  PMID: 20704551 BACKGROUND

MeSH Terms

Conditions

Cholecystitis; Bronchiolitis Obliterans Syndrome; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• BEDİRHAN GÜNEL, MD

  Kocaeli City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: There will be 2 parallel study arms where sevoflurane and desflurane are administered.

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: June 13, 2024
• Study Start: June 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: December 31, 2025
• Last Updated: February 5, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)