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临床试验/NCT03563833
NCT03563833Unknown不适用

Investigation of the Effects of Minimal and High Flow Anesthesia on Thiol Disulfide Balance and Peripheral Tissue Saturation (StO2) in Hypotensive Anesthesia Applications

Recep Tayyip Erdogan University Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年5月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
70
试验地点
2
主要终点
Thiol Disulfide Balance

研究概览

简要总结

The effects of Minimal Flow Anesthesia (0.4 l / min) and High Flow Anaesthesia (2 l / min) on tissue oxygen saturation (St02) and thiol / disulfide balance in hypotensive anesthesia operations will be investigated.

详细描述

The oxidative stress at the cellular level and the possible effects of general anesthesia techniques on the antioxidant system make the method of anesthesia more important.

The effects of Minimal Flow Anesthesia (0.4 l / min) and High Flow Anaesthesia (2 l / min) on tissue oxygen saturation (St02) and thiol / disulfide balance in hypotensive anesthesia operations will be investigated.

Minimal flow anesthesia is widely used because of its advantages such as cost reduction, prevention of environmental pollution, minimization of heat and humidity loss.

Hypotensive anesthesia is preferred in some specialized surgical procedures in order to reduce bleeding and improve the surgical field of view.

The use of hypotensive anesthesia and inhalation agents may cause hypoperfusion at the tissue level and cause hypoxia-induced oxidative stress and initiate cell damage.

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
None

入排标准

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

入选标准

  • ASA (American Society of Anesthesiologists) I tympanoplasty operations with hypotensive anesthesia,
  • ASA (American Society of Anesthesiologists) II tympanoplasty operations with hypotensive anesthesia,

排除标准

  • operations in less than one hour
  • uncontrolled hypertension
  • DM (Diabetes Mellitus)
  • cerebrovascular disease
  • coagulopathy
  • morbid obesity ((BMI ≥ 35)
  • renal disease

研究组 & 干预措施

Minimal Flow Anesthesia

Other

Minimal Flow Anesthesia (50% O2, 50% air), Desflurane (MAC = 4,5). In hypotensive anesthesia application; Remifentanil will be used at infusion rates of 0.025-0.1μg / kg / min after a loading dose of 1 μg / kg / min, with mean Arterial Pressure 55-65 mmHg.

Before the induction of anesthesia and 30 minutes of anesthesia, 2 ml of venous blood sample will be taken from the patients and simultaneous tissue oxygen saturation will be recorded. Serum thiol disulfide levels obtained from the blood sample of the recipient will be studied in the biochemistry research laboratory using the method developed by Erel et al.

干预措施: Minimal Flow Anesthesia (Other)

High Flow Anesthesia

Other

High Flow Anesthesia (50% O2, 50% air), Desflurane (MAC = 4,5) In hypotensive anesthesia application; Remifentanil will be used at infusion rates of 0.025-0.1μg / kg / min after a loading dose of 1 μg / kg / min, with mean Arterial Pressure 55-65 mmHg.

Before the induction of anesthesia and 30 minutes of anesthesia, 2 ml of venous blood sample will be taken from the patients and simultaneous tissue oxygen saturation will be recorded. Serum thiol disulfide levels obtained from the blood sample of the recipient will be studied in the biochemistry research laboratory using the method developed by Erel et al.

干预措施: High Flow Anesthesia (Other)

结局指标

主要结局

Thiol Disulfide Balance

时间窗: For two groups; First blood sample will be taken 30 min before the start of surgery, second blood sample will be taken at the 60th min of the surgery

Change of Oxidative Stress Marker

次要结局

  • StO2(For two groups; simultaneously, 30 min before the start of surgery, 60th min of the surgery)

研究者

发起方
Recep Tayyip Erdogan University Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Şule Batçık

Assistant Professor

Recep Tayyip Erdogan University Training and Research Hospital

研究点 (2)

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