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

Sponsor

Astana Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT05696509

Collaborator

(none)

Enrollment

Location

Arms

33.4

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Mitral Valve Insufficiency Aortic Valve Insufficiency	Drug: Propofol Drug: Isoflurane Drug: Sevoflurane	Phase 3

Detailed 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=t2DN/confidence intervalN+t2α, which will allow to identify the static significance of the study.

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.

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jan 3, 2020

Actual Primary Completion Date :

Oct 13, 2022

Actual Study Completion Date :

Oct 16, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Propofol Anesthetic	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. Other Names: Anesthesia
Other: Isofluran Anesthetic	Drug: Isoflurane Isoflurane was used as an anaesthetic in a dose of - 1.1-1.2 MAC Other Names: Anesthesia
Other: Sevofluran Anesthetic	Drug: Sevoflurane sevoflurane was used as an anaesthetic in a dose of - 1.7-1.9 MAC Other Names: Anesthesia

Arm

Intervention/Treatment

Other: Propofol

Anesthetic

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.

Other Names:

Anesthesia

Other: Isofluran

Anesthetic

Drug: Isoflurane

Isoflurane was used as an anaesthetic in a dose of - 1.1-1.2 MAC

Other Names:

Anesthesia

Other: Sevofluran

Anesthetic

Drug: Sevoflurane

sevoflurane was used as an anaesthetic in a dose of - 1.7-1.9 MAC

Other Names:

Anesthesia

Outcome Measures

Primary Outcome Measures

cardiac index [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 consumption [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.
Oxygen delivery [1 year]
The oxygen delivery was found by formula (DO2 = CI* CaO2)