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临床试验/NCT05695287
NCT05695287已完成1 期

The Effects of Sevoflurane, Isoflurane and Propofol on the Hemodynamic, Body Energy Expenditure During Cardiac Surgery in Adults: a Randomized Clinical Trial

Astana Medical University1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2021年1月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
89
试验地点
1
主要终点
cardiac stroke

研究概览

简要总结

Abstract Anaesthetic support for cardiac surgery significantly influences the course of the intraoperative period and the success of the postoperative period. Total intravenous anaesthesia and inhalation anaesthesia are the traditional methods of anaesthesia in cardiac surgery. However, there are few studies assessing the effectiveness of surgical aggression protection in cardiac surgery.

Objectives: To study the effectiveness of body protection against surgical aggression by TIVA and inhalational anaesthesia in cardiac surgery.

Materials and methods. The examination and treatment data of 89 patients were included in the study. All patients underwent coronary artery bypass grafting, mitral valve replacement/plasty, aortic valve replacement cardiopulmonary bypass conditions.

The patients were divided into 2 groups according to the type of disease: the first (1) group with coronary heart disease. The second (2) group with valvular heart disease. There were 65 patients in the first group and 22 in the second. Both groups were divided into 3 subgroups according to the type of anaesthesia: patients anaesthetised with propofol, with sevoflurane, with isoflurane.

详细描述

All patients were divided into 2 groups according to the type of disease: the first (1) group with coronary heart disease. The second (2) group with valvular heart disease. There were 65 patients in the first group and 22 in the second. Both groups were divided into 3 subgroups according to the type of anaesthesia: patients anaesthetised with propofol, with sevoflurane, with isoflurane.

The study was conducted in 5 stages:

  1. Initial haemodynamic parameters and oxygen transport function of the patient's blood before anaesthesia were determined;
  2. after tracheal intubation;
  3. Before the CPB;
  4. after the CPB;
  5. The post-operative period until the patient is extubated. Before induction into anaesthesia, haemodynamic monitoring was started on admission to the operating theatre using a Nihon Kohden monitor (Japan). The right radial artery was catheterised for invasive monitoring of systemic arterial pressure and arterial blood sampling, and a catheter was then inserted into the central jugular vein (under ultrasound machine control) and guided into the right atrium for mixed venous blood sampling.

Cardiac stroke volume was determined by transthoracic echocardiography (CS=end diastolic volume - end systolic volume). Cardiac output (CO=CS x heart rate), cardiac index (CI=CO/body surface area) were determined. We determined blood oxygen content using the formula CaO2 (arterial ABB) and CvO2 (central mixed venous ABB) = [(1.34 × Hb × SO2) + (PO2 × 0.031)] / 100. Arteriovenous difference = CaO2-CvO2. Oxygen delivery was determined using the formula (DO2 = CI* CaO2). Oxygen consumption (VO2 = Cardiac index (CI)*AVD or VO2 = CO × (CaO2 - CvO2) ~ CO × Hb × 1.34 × (SaO2 - SvO2) / 100).

In the second stage, after tracheal intubation, indirect calorimetry was used to determine VO2, energy expenditure during anaesthesia using a Spirometry device (Oxford, UK), which was connected to an endotracheal tube and continuously showed oxygen demand and energy expenditure. A transesophageal echocardiography sensor was used to determine cardiac output. Additionally, the cardiac output was determined by Fick's formula in patients with CHD. The same tests (cardiac output, cardiac index, consumption, oxygen delivery, energy expenditure) were performed in the third and fourth stages of anaesthesia. In the last stage, the consumption of muscle relaxants and opioid analgesics was calculated to assess the pharmaco-efficiency of anaesthetics. The time of extubation and the time of transfer of the patient to the specialist department were determined.

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
Single (Participant)

入排标准

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

入选标准

  • • The age is between 40-60 years old;
  • Mitral valve insufficiency grade 3-4;
  • Aortic valve insufficiency grade 3-4;
  • Participants of both sexes will be included in the study;
  • Signed informed consent.

排除标准

  • • pregnancy (risk to the baby and the mother)
  • allergenic patients (anaphylactic shock).
  • vulnerable groups.
  • current congestive heart failure;
  • current unstable angina pectoris;
  • preoperative hemodynamic instability, defined as the use of vasopressors;

研究组 & 干预措施

Propofol

Other

Anesthesia

干预措施: Propofol (Drug)

Isofluran

Other

Anesthesia

干预措施: Isoflurane (Drug)

Sevofluran

Other

Anesthesia

干预措施: Sevoflurane (Drug)

结局指标

主要结局

cardiac stroke

时间窗: 1 year

The cardiac stroke (CS) volume was determined by transthoracic echocardiography (CS =end diastolic volume-end systolic volume).

cardiac index

时间窗: 1 year

cardiac index (CI=CO/body surface area

Oxygen consumption

时间窗: 1 year

oxygen consumption (VO2 = Cardiac index \*AVD or VO2 = CO × (CaO2 - CvO2) \~ CB × Hb × 1,34 × (SaO2 - SvO2) / 100)

Oxygen delivery

时间窗: 1 year

The oxygen delivery was found by formula (DO2 = CI\* CaO2)

次要结局

未报告次要终点

研究者

发起方
Astana Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bekzat Baiterek

Clinical Professor

Astana Medical University

研究点 (1)

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