Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05696509
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2022-12-21
Brief Title:
Influence of Anesthetics on Clinical Outcome in Mitral and Aortic Valve Replacement in Adults
Sponsor:
Astana Medical University
Organization:
Astana Medical University
Study Overview
Official Title:
Influence of Anesthetics on Clinical Outcome in Mitral and Aortic Valve Replacement in Adults a Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 replacementplasty 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 mgkgh intravenously on perfusion In Group 2 the anaesthetic used was sevoflurane in a dose of 17-19 MAC Group 3 used isoflurane in the dose of 11-12 MAC as anaesthetic Statistical analysis was done by the method of single factor analysis of variance and Kruskal Wallis criterion
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 replacementplasty 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 mgkgh intravenously on perfusion In Group 2 the anaesthetic used was sevoflurane in a dose of 17-19 MAC Group 3 used isoflurane in the dose of 11-12 MAC as anaesthetic Statistical analysis was done by the method of single factor analysis of variance and Kruskal Wallis criterion
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 replacementplasty under cardiopulmonary bypass CPB conditions This research work was conducted between 2020 and 2022 To calculate the sample size the investigators used the formula nt2DNconfidence intervalNt2α 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 patients 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 CSend diastolic volume - end systolic volume Cardiac output COCS x heart rate cardiac index CICObody surface area were determined the investigators determined blood oxygen content using the formula CaO2 arterial ABB and CvO2 central mixed venous ABB 134 Hb SO2 PO2 0031 100 Arteriovenous difference CaO2-CvO2 Oxygen delivery was determined using the formula DO2 CI CaO2 Oxygen consumption VO2 Cardiac index CIAVD or VO2 CO CaO2 - CvO2 CO Hb 134 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 Ficks 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
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 patients 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 CSend diastolic volume - end systolic volume Cardiac output COCS x heart rate cardiac index CICObody surface area were determined the investigators determined blood oxygen content using the formula CaO2 arterial ABB and CvO2 central mixed venous ABB 134 Hb SO2 PO2 0031 100 Arteriovenous difference CaO2-CvO2 Oxygen delivery was determined using the formula DO2 CI CaO2 Oxygen consumption VO2 Cardiac index CIAVD or VO2 CO CaO2 - CvO2 CO Hb 134 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 Ficks 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None