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临床试验/NCT06457958
NCT06457958撤回4 期

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

Kocaeli City Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
发起方
入组人数
48
试验地点
1
主要终点
Comparison of the Effects of Sevoflurane and Desflurane Inhalation Anesthetics on Blood Heme Oxygenase-1 Gene and Protein Levels

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Sevoflurane Group (Drug)

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.

干预措施: Desflurane Group (Drug)

结局指标

主要结局

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

时间窗: Postoperative at hour 1

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.

次要结局

未报告次要终点

研究者

发起方
Kocaeli City Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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