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

Primary Purpose

Mitral Valve Insufficiency, Aortic Valve Insufficiency

Status
Completed
Phase
Phase 3
Locations
Kazakhstan
Study Type
Interventional
Intervention
Propofol
Isoflurane
Sevoflurane
Sponsored by
Astana Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mitral Valve Insufficiency focused on measuring clinical outcome, sevoflurane, isoflurane, propofol, Mitral Valve Insufficiency, Aortic Valve Insufficiency

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Bekzat

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Propofol

Isofluran

Sevofluran

Arm Description

Anesthetic

Anesthetic

Anesthetic

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 21, 2022
Last Updated
January 13, 2023
Sponsor
Astana Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05696509
Brief Title
Influence of Anesthetics on Clinical Outcome in Mitral and Aortic Valve Replacement in Adults
Official Title
Influence of Anesthetics on Clinical Outcome in Mitral and Aortic Valve Replacement in Adults: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2020 (Actual)
Primary Completion Date
October 13, 2022 (Actual)
Study Completion Date
October 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Astana Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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=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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Insufficiency, Aortic Valve Insufficiency
Keywords
clinical outcome, sevoflurane, isoflurane, propofol, Mitral Valve Insufficiency, Aortic Valve Insufficiency

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Other
Arm Description
Anesthetic
Arm Title
Isofluran
Arm Type
Other
Arm Description
Anesthetic
Arm Title
Sevofluran
Arm Type
Other
Arm Description
Anesthetic
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Anesthesia
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Isoflurane
Other Intervention Name(s)
Anesthesia
Intervention Description
Isoflurane was used as an anaesthetic in a dose of - 1.1-1.2 MAC
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Anesthesia
Intervention Description
sevoflurane was used as an anaesthetic in a dose of - 1.7-1.9 MAC
Primary Outcome Measure Information:
Title
cardiac index
Description
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).
Time Frame
1 year
Title
Oxygen consumption
Description
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.
Time Frame
1 year
Title
Oxygen delivery
Description
The oxygen delivery was found by formula (DO2 = CI* CaO2)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alibek Kh Mustafin, Professor
Organizational Affiliation
Astana Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Bekzat
City
Astana
ZIP/Postal Code
0.00001
Country
Kazakhstan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
To study the effect of anesthetics on clinical outcome after mitral and aortic valve replacement in adults.

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

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