Clinical trial NCT06457958: Effect of Sevoflurane and Desflurane on Heme Oxygenase-1 Expression in Elective Cholecystectomy
Official title: The Effect of Sevoflurane and Desflurane Anesthetic Agents Used in Elective Cholecystectomy Surgery on Heme Oxygenase-1 mRNA Expression and Heme Oxygenase-1 Protein Levels: A Comparative Prospective Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cholecystitis, Chronic
Keywords: Anesthetics, Inhalation
Heme Oxygenase-1
Oxidative Stress
Sevoflurane
Desflurane
Anesthesia, General
Cholecystectomy
Lead sponsor: Kocaeli City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-06-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be 2 parallel study arms where sevoflurane and desflurane are administered.
Primary purpose: BASIC_SCIENCE

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.

Detailed description: In this study, the aim is to compare the effects of two commonly used inhalation agents, sevoflurane and desflurane, on heme oxygenase-1 (HO-1) enzyme levels. The total amounts of sevoflurane and desflurane administered to patients, as well as their overall oxygen consumption, will also be monitored. This data will allow for the exploration of how these inhalation agents and oxygen intake influence HO-1 enzyme levels, both across and within groups. The goal is to determine which agent demonstrates more effective cellular protection at the molecular level. This study will scientifically investigate how these commonly used agents impact HO-1 enzyme levels and gene expression, drawing conclusions based on the data obtained. The findings are anticipated to provide valuable insights for future clinical research and expand horizons in this field.

Study Design and Power Analysis:

The study follows a comparative prospective parallel-group design and is classified as low-risk scientific research. Sample size determination was based on a power analysis using G\*Power 3.1 software. A t-test will be employed for comparison between two independent groups, with an alpha error probability set at 0.05 and a power (1-beta error probability) of 0.90. A total of 48 patients, with 24 in each group, will be included.

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Procedures:

Preoperative blood samples will be obtained from enrolled patients 1 hour before surgery. Patients undergoing general anesthesia will be randomly assigned to receive either sevoflurane or desflurane inhalation agent. Standard anesthesia procedures will be followed. Total amounts of sevoflurane/desflurane consumed, oxygen consumption, and vital parameters will be recorded throughout the procedure. Postoperative blood samples will be collected 1 hour after extubation. Patient follow-up will then conclude. Blood samples will be stored in the hospital's biochemistry laboratory. HO-1 blood protein levels will be measured using the ELISA method, and HO-1 mRNA expression will be assessed using PCR. This study aims to determine which inhalation agent offers superior cellular protection at the molecular level by assessing their effects on HO-1 enzyme levels and gene expression.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Comparison of the Effects of Sevoflurane and Desflurane Inhalation Anesthetics on Blood Heme Oxygenase-1 Gene and Protein Levels
timeFrame: Postoperative at hour 1
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli City Hospital
state: Izmit
Study officials:
affiliation: Kocaeli City Hospital
name: BEDİRHAN GÜNEL, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.