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临床试验/NCT06166186
NCT06166186已完成不适用

Effect of Intraoperative Music on Inflammatory Response in Adult Living Donor Hepatectomy.

Istinye University1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2023年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
1
主要终点
Differences in Interleukin-6 (IL-6)

研究概览

简要总结

It has been reported that non-pharmacological methods can be used as an alternative in addition to pharmacological methods to reduce pain, anxiety, stress and inflammatory response that begins with the surgical incision in the intraoperative period and continues throughout the operation. It has been reported that music can be used as an alternative non-pharmacological method to reduce pain and anxiety in the perioperative period, as well as surgical stress and the related stress response.

The aim of this study is to test the hypothesis that music used as a non-pharmacological method in the intraoperative period can reduce inflammatory response in living donor hepatectomy.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing donor hepatectomy
  • American Society of Anesthesiologists class 1 to 2
  • Ability to consent

排除标准

  • American Society of Anesthesiologists greater than 2
  • Documented or known sensitivity to any drug to be used in the study.
  • Patient with immunosuppressant/ cytotoxic/ steroid therapy.
  • not understand the aim and objectives of the study

结局指标

主要结局

Differences in Interleukin-6 (IL-6)

时间窗: 4 hours

Serum levels of IL-6 will be measured preoperatively and postoperatively.

次要结局

  • Difference between serum levels of total antioxidant capacity (TAC) at preoperative and postoperative period.(4 hours)
  • Difference in tumor necrosis factor alpha (TNF-alfa)(4 hours)
  • Differences in preoperative State-Trait Anxiety Inventory scores(20 minutes)
  • Difference between serum levels of total oxidant capacity (TOC) at preoperative and postoperative period.(4 hours)
  • Difference in c-reactive protein (CRP)(24 hours)
  • Difference in alanine aminotransferase (ALT)(24 hours)
  • Difference in creatinine(24 hours)
  • Differences in pain scores(24 hours)
  • Difference in aspartate aminotransferase (AST)(24 hours)
  • Differences in postoperative State-Trait Anxiety Inventory scores(20 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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