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The Effects of Sevoflurane, Isoflurane and Propofol During Cardiac Surgery

Primary Purpose

Coronary Artery Disease, Mitral Valve Insufficiency, Aortic Valve Insufficiency

Status
Completed
Phase
Phase 1
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 Coronary Artery Disease focused on measuring heart valve, CHD, sevoflurane, propofol, isoflurane

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

Anesthesia

Anesthesia

Anesthesia

Outcomes

Primary Outcome Measures

cardiac index
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 delivery
The oxygen delivery was found by formula (DO2 = CI* CaO2)
cardiac stroke
The cardiac stroke (CS) volume was determined by transthoracic echocardiography (CS =end diastolic volume-end systolic volume).

Secondary Outcome Measures

Full Information

First Posted
December 21, 2022
Last Updated
January 12, 2023
Sponsor
Astana Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05695287
Brief Title
The Effects of Sevoflurane, Isoflurane and Propofol During Cardiac Surgery
Official Title
The Effects of Sevoflurane, Isoflurane and Propofol on the Hemodynamic, Body Energy Expenditure During Cardiac Surgery 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 22, 2021 (Actual)
Primary Completion Date
November 19, 2022 (Actual)
Study Completion Date
December 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 effectiveness of body protection against surgical aggression by TIVA and inhalational anaesthesia in cardiac surgery. Materials and methods. The examination and treatment data of 89 patients were included in the study. All patients underwent coronary artery bypass grafting, mitral valve replacement/plasty, aortic valve replacement cardiopulmonary bypass conditions. The patients were divided into 2 groups according to the type of disease: the first (1) group with coronary heart disease. The second (2) group with valvular heart disease. There were 65 patients in the first group and 22 in the second. Both groups were divided into 3 subgroups according to the type of anaesthesia: patients anaesthetised with propofol, with sevoflurane, with isoflurane.
Detailed Description
All patients were divided into 2 groups according to the type of disease: the first (1) group with coronary heart disease. The second (2) group with valvular heart disease. There were 65 patients in the first group and 22 in the second. Both groups were divided into 3 subgroups according to the type of anaesthesia: patients anaesthetised with propofol, with sevoflurane, with isoflurane. 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 extubated. 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. We 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 in patients with CHD. 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 specialist 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 in both groups were anesthetized with fentanyl at a dose of 5-7 µg/kg, ketamine 1.5-2 mg/kg, and propofol 1-1.5 mg/kg intravenously fractionally. Pipecuronium bromide 0.04-0.07 mg/kg was used as muscle relaxant in all patients. 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 (BBRAUN). In Group 2, sevoflurane was used as an anaesthetic in a dose of - 1.7-1.9 MAC. In Group 3 isoflurane was used as the anesthetic in the dose of 1.1-1.2 MAC. Fentanyl 100 µg intravenously was administered fractionally in all groups to increase heart rate and blood pressure, and pipecuronium bromide 2 mg intravenously for myorelaxation. During CPB, propofol at a dose of 6 mg/kg/h intravenously via perfusion was used in all patients in all groups. Anaesthesia regimen: fentanyl 100 µg IV every 30 min; myorelaxant pipecuronium bromide 2 mg every 40-60 min. Norepinephrine solution was administered at a dose of 0.07 µg/kg/min intravenously on perfusion and dobutamine 5 µg/kg/min after CPB in all patients at the same dosages in all groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Mitral Valve Insufficiency, Aortic Valve Insufficiency
Keywords
heart valve, CHD, sevoflurane, propofol, isoflurane

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Other
Arm Description
Anesthesia
Arm Title
Isofluran
Arm Type
Other
Arm Description
Anesthesia
Arm Title
Sevofluran
Arm Type
Other
Arm Description
Anesthesia
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Propofol;
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)
В качестве анестетика использовали изофлуран - 1,1-1,2 ПДК.
Intervention Description
Isoflurane
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
в качестве анестетика использовали севофлуран в дозе - 1,7-1,9 ПДК.
Intervention Description
Sevoflurane
Primary Outcome Measure Information:
Title
cardiac index
Description
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)
Time Frame
1 year
Title
Oxygen delivery
Description
The oxygen delivery was found by formula (DO2 = CI* CaO2)
Time Frame
1 year
Title
cardiac stroke
Description
The cardiac stroke (CS) volume was determined by transthoracic echocardiography (CS =end diastolic volume-end systolic volume).
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 Director
Facility Information:
Facility Name
Bekzat
City
Astana
ZIP/Postal Code
0.00001
Country
Kazakhstan

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Sevoflurane, Isoflurane and Propofol During Cardiac Surgery

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