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Influence of Anesthetics on Clinical Outcome During Cardiac Surgery in Adults

Primary Purpose

CHD - Coronary Heart Disease

Status
Completed
Phase
Not Applicable
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 supportive care trial for CHD - Coronary Heart Disease focused on measuring sevoflurane, isoflurane, propofol, Oxygen consumption, energy expenditure, oxygen transport, metabolic status

Eligibility Criteria

45 Years - 67 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: The age is over 40 years old. coronary revascularization or >50% stenosis on coronary angiography CHD. Multivessel coronary lesions. 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 stroke (CS) 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.
Oxygen transport
Oxygen delivery was determined by the formula (DO2 = CI* CaO2)
Oxygen consumption
Oxygen consumption (VO2 = Cardiac index *AVD or VO2 = CO × (CaO2 - CvO2) ~ CB × Hb × 1,34 × (SaO2 - SvO2) / 100)
energy expenditure
energy expenditure during anaesthesia indirect calorimetry was used with the help of spirometry device "Spirometry" (UK Oxford) which was connected to the endotracheal tube and continuously showed oxygen demand and energy expenditure

Secondary Outcome Measures

Full Information

First Posted
December 16, 2022
Last Updated
January 11, 2023
Sponsor
Astana Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05693428
Brief Title
Influence of Anesthetics on Clinical Outcome During Cardiac Surgery in Adults
Official Title
Changes in Blood Oxygen Transport Function and Body Energy Expenditure During Anaesthesia 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, 2022 (Actual)
Primary Completion Date
November 19, 2022 (Actual)
Study Completion Date
November 26, 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 Cardiac surgery in adults is associated with the occurrence of post-operative complications. Even minor complications can increase the cost of their treatment. Given the potentially preventable nature of a number of these postoperative complications, preventive methods should be used to improve outcomes after cardiac surgery. One of them, is the choice of anaesthetic technique. Objectives: To evaluate the effects of sevoflurane, isoflurane and propofol on blood oxygen transport function and body energy expenditure during cardiac surgery in adults. Materials and methods. A total of 90 patients were included in the study. All patients were divided into 3 groups: 1- (n=30) included patients who were anesthetized with propofol. The second group (n=30) consisted of patients who underwent sevoflurane inhalation anaesthesia. Group 3 (n=30) was treated with isoflurane. All patients underwent coronary artery bypass grafting under cardiopulmonary bypass.
Detailed Description
Introduction Anaesthetic support for various types of cardiac surgery, such as coronary artery bypass grafting (CABG), heart valve repair or replacement, ascending aorta surgery, heart transplantation and surgical treatment of congenital heart disease, share many principles. Indirect calorimetry can be an indicator of homeostatic changes during surgery. Stress increases oxygen consumption (VO2) and during anaesthesia there is a decrease in VO2. Cardiac surgery in adults is associated with the occurrence of postoperative complications [1]. Even minor complications, can increase the cost of their treatment. Given the potentially preventable nature of a number of these postoperative complications, preventive methods should be used to improve outcomes after cardiac surgery. One of them, is the choice of anaesthetic technique [2]. Tissues vary considerably in their sensitivity to hypoxia. Neurons tolerate hypoxia for only a few minutes, whereas the smooth muscles of the bladder go several days without oxygen. This has important implications for oxygen transport and monitoring of tissue hypoxia in patients. The mechanisms controlling the distribution of oxygen in the body are not fully understood (3). Increased oxygen extraction, the ratio of consumption to transport, has been associated with poor outcome after surgery. The authors note [4] a -65 ml decrease in oxygen consumption after general anaesthesia. Researchers [5,6] found that surgery and anaesthesia did not significantly affect oxygen consumption and energy expenditure during anaesthesia. However, Julia Jakobsson et al (2021) state that general anaesthesia reduced VO2 by approximately one third in elderly patients undergoing major abdominal surgery. These changes require further evaluation in relation to outcomes and surgery (7). Cerebral blood flow was reduced by 27.6% and cerebral vascular resistance by 51% at moderate propofol concentrations. Brain oxygen consumption was reduced by 18.2% [8]. Oxygen delivery (DO2) is an important marker of O2 transport than arterial blood oxygen saturation (SaO2). Anaesthetics (propofol or sevoflurane) had no significant effect on DO2 . In addition, no correlation was found between SaO2 and DO2. DO2 data may provide useful additional information about the patient's condition, especially with low SaO2 [9]. A decrease in metabolic rate during anaesthesia has been noted in patients with hypothermia, but this did not alter DO2. A significant decrease in O2ER might be partly due to a shift to the left of the oxyhemoglobin dissociation curve, as indicated by a decrease in P50 [10]. Oxygen consumption during general anaesthesia was independent of the type of anaesthetics. General anaesthesia leads to a marked decrease in oxygen consumption, but during recovery the O2 uptake can increase dramatically. Meperidine can suppress and reduce postoperative VO2 to the level observed after TIA [11]. Indirect calorimetry can be an indicator of homeostatic changes during surgery. Stress increases oxygen consumption and during anaesthesia there is a decrease in VO2 due to lack of kinetic energy as a cellular metabolic response to surgical trauma and anaesthesia. More research is needed to find out which oxygen consumption measurement system is the most appropriate for anaesthesia and what the VO2 limit values might be [12]. In view of the above opinion of the authors and the lack of studies that have shown the effects of sevoflurane, isoflurane and propofol on energy expenditure, blood oxygen and oxygen transport function, this needs to be further investigated. Objectives: To evaluate the effects of sevoflurane, isoflurane and propofol on blood oxygen transport function and body energy expenditure during cardiac surgery in adults. Methods Study type: single-centre prospective randomised clinical trial. The study includes data from 90 patients operated on at the Cardiosurgery Department of the RSE Medical Centre Hospital of the President's Affairs Administration of the Republic of Kazakhstan. All patients underwent coronary artery bypass grafting under cardiopulmonary bypass (CPB). This research work was conducted between 2021 and 2022. To calculate the sample size, we used the formula n=t2*D*N/confidence interval*N+t2*α, which will allow to identify the static significance of the study. This research was approved by the Local bioethical committee of Non-commercial joint-stock company AMU №3 and written informed consent was obtained from all subjects. All patients were divided into 3 groups: 1 (control group) (n=30) consisted of patients who underwent anaesthesia with propofol (P). The second group (n=30) were patients who received sevoflurane inhalation anaesthesia (S). Group 3 (n=30) with isoflurane (I). The study was conducted in 5 stages: determined the patient's baseline values before anaesthesia; after tracheal intubation; Before the CPB; after the CPB; The post-operative period. Before induction into anaesthesia, haemodynamic monitoring with Nihon Kohden monitors (Japan) was initiated on admission to the operating theatre. The right radial artery was catheterised for invasive systemic pressure monitoring and arterial blood sampling, then a catheter was 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=CB/body surface area) were determined. Blood oxygen content was determined using the formula CaO2 (arterial blood gas ABG) and CvO2 (central mixed venous BG) = [(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)*AVR or VO2 = CB × (CaO2 - CvO2) ~ CB × 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" (Oxford, UK), which was connected to an endotracheal tube and continuously showed oxygen demand and energy expenditure. Additionally, cardiac output was determined using Fick's formula. In the third and fourth stages of anaesthesia the same tests (cardiac output, cardiac index, consumption, oxygen delivery and energy expenditure) were determined. In the last stage to assess the pharmaco-efficiency of anaesthetics, the consumption of muscle relaxants and opioid analgesics was calculated. The time of extubation and the time of transfer of the patient to the specialist department were determined. All patients were given the same type of premedication: 30-40 minutes before surgery, 0.3 mg/kg promedol was administered intramuscularly. Patients continued to take their usual baseline drugs both before and on the day of surgery to prevent withdrawal syndrome and to reduce the risk of myocardial ischaemia in the perioperative period. All patients in both groups were given fentanyl in 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 5-6 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 anaesthetic. In all groups fentanyl 100 µg intravenously was administered fractionally to increase heart rate and blood pressure, also pipecuronium bromide 2 mg intravenously for muscle relaxation. During CPB in all patients in all groups, propofol was used at a dose of 6 mg/kg/h intravenously via perfusion, analgesic regimen: fentanyl 100 µg intravenously every 30 min; myorelaxant piperonium bromide 2 mg every 40-60 min. Norepinephrine solution was administered at a dose of 0.05 µg/kg/min intravenously on perfusor after CPB in all patients at the same dosages in all groups. Aim to use cardiotonic drugs: in order to maintain mean arterial perfusion pressure (CPB causes cytokine storm and vasodilation). for inotropic support (for reperfusion syndrome, resulting in a lower ejection fraction). The depth of anaesthesia was monitored with a processed electroencephalogram, such as a BIS. Statistical analysis was performed using IBM SPSS Statistics 20 package using one-factor analysis of variance for independent samples and nonparametric Kraskel Wallis test. The Kraskel-Wallis test was applied only to myorelaxant consumption, as the distribution was non-normal on this parameter. A Pearson and Spearman correlation analysis was also performed to determine the significance of the association between cardiac index and oxygen consumption, as well as energy expenditure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CHD - Coronary Heart Disease
Keywords
sevoflurane, isoflurane, propofol, Oxygen consumption, energy expenditure, oxygen transport, metabolic status

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (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 5-6 mg/kg/h intravenously on a perfusor.
Intervention Type
Drug
Intervention Name(s)
Isoflurane
Intervention Description
isoflurane was used as anaesthetice of - 1.1-1.2 MAC.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
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
Cardiac stroke (CS) 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.
Time Frame
1 year
Title
Oxygen transport
Description
Oxygen delivery was determined by the formula (DO2 = CI* CaO2)
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
energy expenditure
Description
energy expenditure during anaesthesia indirect calorimetry was used with the help of spirometry device "Spirometry" (UK Oxford) which was connected to the endotracheal tube and continuously showed oxygen demand and energy expenditure
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The age is over 40 years old. coronary revascularization or >50% stenosis on coronary angiography CHD. Multivessel coronary lesions. 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

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Influence of Anesthetics on Clinical Outcome During Cardiac Surgery in Adults

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