Influence of Anesthetics on Clinical Outcome in Mitral and Aortic Valve Replacement in Adults: a Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Oxygen consumption
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 effect of anesthetics on clinical outcome after mitral and aortic valve replacement in adults.
Methods. The data of 75 patients operated in the Cardiosurgery Department of the Medical Center Hospital of the Presidential Administration of the Republic of Kazakhstan were included in the study. All patients underwent mitral, aortic valve replacement/plasty under cardiopulmonary bypass (CPB) conditions.
All patients were divided into 3 groups according to the type of anaesthesia: the first (1) group patients anaesthetised with propofol (P), the second group with sevoflurane (S), and the last one is with isoflurane (I).
To maintain anaesthesia in Group 1 propofol was used as anaesthetic in a dose of 6 mg/kg/h intravenously on perfusion. In Group 2 the anaesthetic used was sevoflurane in a dose of 1.7-1.9 MAC. Group 3 used isoflurane in the dose of 1.1-1.2 MAC as anaesthetic. Statistical analysis was done by the method of single factor analysis of variance and Kruskal Wallis criterion.
详细描述
This study includes data from 90 patients operated in the Cardiosurgery Department of the Medical Center Hospital of the Presidential Administration of the Republic of Kazakhstan were included in the study. All patients underwent mitral, aortic valve replacement/plasty under cardiopulmonary bypass (CPB) conditions. This research work was conducted between 2020 and 2022. To calculate the sample size, the investigators used the formula n=t2*D*N/confidence interval*N+t2*α, which will allow to identify the static significance of the study.
All patients were divided into 3 groups according to the type of anaesthesia: the first (1) group patients anaesthetised with propofol (P), the second group with sevoflurane (S), and the last one is with isoflurane (I).
The study was conducted in 5 stages:
- Initial haemodynamic parameters and oxygen transport function of the patient's blood before anaesthesia were determined;
- After tracheal intubation;
- Before the CPB;
- After the CPB;
- The post-operative period until the patient is transferred to the specialized department.
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.
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
- 否
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
Anesthetic
干预措施: Propofol (Drug)
Isofluran
Anesthetic
干预措施: Isoflurane (Drug)
Sevofluran
Anesthetic
干预措施: Sevoflurane (Drug)
结局指标
主要结局
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 utilization factor (KYO2) = VO2 / DO2 × 100 = \[(CaO2 - CvO2) / CaO2\] × 100.
cardiac index
时间窗: 1 year
The cardiac stroke (CS) volume was determined by transthoracic echocardiography (CS=end diastolic volume-end systolic volume). There were also determined the cardiac output (CO=CS x heart rate), cardiac index (CI=CO/body surface area).
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
Bekzat Baiterek
2nd year doctoral student, anesthesiologist, resuscitator
Astana Medical University