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临床试验/NCT07152912
NCT07152912招募中不适用

A Comparative Study Between the Impact of Isoflurane and Sevoflurane on Oxidative Stress in Patients Undergoing Laparoscopic Cholecystectomy

Ain Shams University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年9月4日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Serum level of superoxide dismutase

研究概览

简要总结

The primary aim of this work is to assess the impact of exposure to isoflurane or sevoflurane as an inhalation anesthetic on the oxidative stress and inflammatory conditions in patients undergoing elective moderate invasive surgery (laparoscopic cholecystectomy).

详细描述

Oxidative stress is defined as "an imbalance between oxidants and antioxidants in favour of the oxidants, leading to a disruption of redox signalling and control and/or molecular damage.

Isoflurane, which has been utilized since the 1980s, has a particularly low metabolism rate and solubility, leading to reduced induction of anesthesia during surgery and shortened recovery time after surgery.

Sevoflurane began to be used a decade later and has a lower blood-gas partition coefficient than the other anesthetics, leading to rapid induction of anesthesia and fast awakening after anesthesia.

研究设计

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

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 20 to 60 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) Physical Status I-II.
  • Undergoing elective laparoscopic cholecystectomy under general anesthesia.

排除标准

  • Refusal of participation in the study by patients.
  • Diabetes (type I or II), endocrine system, and immune system diseases.
  • Chronic infection and sepsis.
  • Cardiac condition as classified bythe New York Heart Association (NYHA) > class II.
  • Hepatic disease: INR > 1.5, and/or albumin < 2.5 g/dL.
  • Renal disease: glomerular filtration rate (GFR) < 85 ml/min.
  • Mental and neurological disorders.

研究组 & 干预措施

Group Iso

Experimental

Patients will receive general anesthesia and maintenance by isoflurane.

干预措施: Isoflurane (Drug)

Group Sev

Experimental

Patients will receive general anesthesia and maintenance by sevoflurane.

干预措施: Sevoflurane (Drug)

结局指标

主要结局

Serum level of superoxide dismutase

时间窗: 6 months postoperatively

Serum level of superoxide dismutase (SOD) will be recorded.

次要结局

  • Serum level of serum soluble programmed cell death-ligand 1(6 months postoperatively)
  • Serum level of nuclear factor erythroid 2-related factor(6 months postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eman adel ali abd moaty

Assistant Lecturer of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University.

Ain Shams University

研究点 (1)

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