Influence of Anesthetics on Clinical Outcome in Mitral and Aortic Valve Replacement in Adults

Mitral Valve Insufficiency Clinical Trial

Official title:

Influence of Anesthetics on Clinical Outcome in Mitral and Aortic Valve Replacement in Adults: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05696509
• Other study ID #: AMU3
• Status: Completed
• Phase: Phase 3
• Start date: January 3, 2020
• Est. completion date: October 16, 2022

Study information

• Verified date: January 2023
• Source: Astana Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

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 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.

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. the investigators 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. 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 specialized department were determined.

All patients continued antihypertensive medication both before and on the day of surgery to prevent the development of withdrawal syndrome and to reduce the risk of perioperative myocardial ischaemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 16, 2022
• Est. primary completion date: October 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Mitral Valve Insufficiency

Intervention

Drug:
• Propofol
To maintain anaesthesia in Group 1 P, propofol was used as an anaesthetic in a dose of 4-6 mg/kg/h intravenously on a perfusor.
• Isoflurane
Isoflurane was used as an anaesthetic in a dose of - 1.1-1.2 MAC
• Sevoflurane
sevoflurane was used as an anaesthetic in a dose of - 1.7-1.9 MAC

Locations

Country	Name	City	State
Kazakhstan	Bekzat	Astana

Sponsors (1)

Lead Sponsor	Collaborator
Astana Medical University

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac index	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).	1 year
Primary	Oxygen consumption	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.	1 year
Primary	Oxygen delivery	The oxygen delivery was found by formula (DO2 = CI* CaO2)	1 year