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临床试验/NCT04310748
NCT04310748已完成不适用

Effects of TIVA and Inhalation Anesthesia on Oxidative Stress Factors During Hypotensive Anesthesia

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
TOS (TOTAL OXIDANE STATUS)

研究概览

简要总结

Total intravenous anesthesia (TIVA) and inhalation anesthesia are two anesthesia methods that can be preferred for the maintenance of anesthesia. Sevoflurane and propofol are drugs used frequently in these methods. This study aims to investigate and compare the effects of inhalation anesthesia using sevoflurane and TIVA using propofol on oxidative stress in patients undergoing controlled hypotensive anesthesia.

详细描述

Controlled hypotension is defined as keeping systolic blood pressure in the range of 80-90 mmHg or mean arterial pressure in the range of 50-65 mmHg. Pharmacological and non-pharmacological methods can be used to achieve controlled hypotension. Intravenous anesthetics, inhalation anesthetics, opioids, calcium channel blockers, beta blockers, nitrate derivatives are frequently used drugs for this purpose.

General anesthesia maintenance is applied in two ways: total intravenous anesthesia (TIVA) and inhalation anesthesia. The pharmacokinetic and pharmacodynamic properties of drugs used in both methods are quite different.

Products of the body's oxidant antioxidant balance can be measured by biochemical methods and information about this balance can be obtained. Thiols are the regions of proteins most susceptible to oxidation, and the conversion of thiols to disulfides and oxyacids is the earliest marker of radical-mediated protein oxidation.

Total antioxidant status (TAS) shows the total effect of all antioxidants in the human body and total oxidant status (TOS) shows the total effect of oxidants.

In this study, it was aimed to investigate and compare the effects of inhalation anesthesia using sevoflurane and total intravenous anesthesia using propofol on oxidative stress in rhinoplasty cases under controlled hypotension. This assessment was planned using TAS (total antioxidant status), TOS (total oxidant status), Catalase, Myeloperoxidase (MPO), Total Thiol, Native Thiol and Disulfide parameters.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Ages of 18-55
  • Who will undergo elective rhinoplasty
  • ASA Physical Status Classification System 1

排除标准

  • Patients with a history of smoking,
  • Patients with a history alcohol use
  • Patients with a history drug use,
  • Body Mass Index (BMI)>30
  • Patients with allergies to drugs to be used
  • Patients who refused to participate in the study Termination Criteria
  • Whose blood pressure values are out of the targets determined in 3 consecutive measurements

研究组 & 干预措施

Total Intravenous Anesthesia(TIVA)

Active Comparator

Anesthesia is maintaining with TIVA (Group 1)

干预措施: Total Intravenous Anesthesia(TIVA) (Drug)

Inhalation Anesthesia

Active Comparator

Anesthesia is maintaining with inhalation anesthesia (Group 2)

干预措施: Inhalation Anesthesia (Drug)

结局指标

主要结局

TOS (TOTAL OXIDANE STATUS)

时间窗: Change from Baseline TOS levels at 2 hours

Evaluation of the effect of anesthesia technique on oxidative stress by TOS values Measurement for TOS is calibrated with hydrogen peroxide and the results are expressed in micromolar by the hydrogen peroxide value per liter (mmol H2O2 equiv / L). 3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.

TAS (TOTAL ANTIOXIDANE STATUS)

时间窗: Change from Baseline TAS levels at 2 hours

Evaluation of the effect of anesthesia technique on oxidative stress by TAS values Plasma TAS levels are measured by a commercial mass developed by Erel. Plasma TAS values are expressed in millimeters with the Trolox value per liter. 3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.

Myeloperoxidase

时间窗: Change from Baseline Myeloperoxidase levels at 2 hours

Evaluation of the effect of anesthesia technique on oxidative stress by Myeloperoxidase values Myeloperoxidase activity is determined by measuring the orange color of o-Dianisidine molecule in oxidized environment with H2O2 at 444 nm colorimetrically. The result is calculated using the molar absorption coefficient of the oxidized o-Dianisidine molecule and defined as Unite / L. 3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.

Parameters of Thiol- Disulphide Homeostasis

时间窗: Change from Baseline Thiol- Disulphide levels at 2 hours

Evaluation of the effect of anesthesia technique on oxidative stress by Thiol - Disulphide Homeostasis values Extra reduction of DTNB and further reduction of the disulfide bond produced after the DTNB reaction are prevented. The total thiol content of the sample is measured at 410 nm using the modified Ellman reagent. Native thiol content is subtracted from the total thiol content and half of the difference obtained gives the amount of disulfide bond. Unit: μmol / L. 3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.

Catalase

时间窗: Change from Baseline Catalase levels at 2 hours

Evaluation of the effect of anesthesia technique on oxidative stress by catalase values The catalase enzyme converts H2O2 into water and oxygen. Catalase enzyme activity decreases in the amount of H2O2 as a result of the dismutase reaction shown by the enzyme in an environment containing H2O2. Catalase enzyme activity is determined by measuring the change in H2O2 concentration at 240 nm. Unit: Unite / L. 3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.

次要结局

  • Surgical Satisfaction: score(postoperative 1 minute)
  • Bleeding Scores(postoperative 1 minute)

研究者

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

Zeynep Nur İncekara

MD, Principal Investigator

Bezmialem Vakif University

研究点 (1)

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