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CHD - Coronary Heart DiseaseNCT05693428

Influence of Anesthetics on Clinical Outcome During Cardiac Surgery in Adults

A study testing Propofol, Isoflurane and Sevoflurane in people with CHD - Coronary Heart Disease, run by Astana Medical University at 1 site in Kazakhstan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 45 to 67 yearsHealthy volunteers can take part
Conditions the study is for
CHD - Coronary Heart Disease
What is being tested?
Propofol, Isoflurane and Sevoflurane
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteKazakhstan
Study dates
22 Jan 2022to 26 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 67 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country.

Kazakhstan1 site
  • Bekzat

    Astana, 0.00001

Other trials in Kazakhstan

About this study

Official title: Changes in Blood Oxygen Transport Function and Body Energy Expenditure During Anaesthesia During Cardiac Surgery in Adults: a Randomized Clinical Trial

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.

Read the 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:

  1. determined the patient's baseline values before anaesthesia;
  2. after tracheal intubation;
  3. Before the CPB;
  4. after the CPB;
  5. 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:

  1. in order to maintain mean arterial perfusion pressure (CPB causes cytokine storm and vasodilation).
  2. 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.

Being tested
Propofol, Isoflurane, Sevoflurane
Keywords
sevoflurane, isoflurane, propofol, Oxygen consumption, energy expenditure, oxygen transport, metabolic status
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PropofolDrug

    Also called Propofol;

    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.

  • IsofluraneDrug

    isoflurane was used as anaesthetice of - 1.1-1.2 MAC.

  • SevofluraneDrug

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

Study groups in NCT05693428
Study groupRoleWhat they receive
PropofolOtherAnesthesia
Receives: Drug: Propofol
IsofluranOtherAnesthesia
Receives: Drug: Isoflurane
SevofluranOtherAnesthesia
Receives: Drug: Sevoflurane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

  2. Oxygen transport

    Oxygen delivery was determined by the formula (DO2 = CI* CaO2)

    Measured: 1 year

  3. Oxygen consumption

    Oxygen consumption (VO2 = Cardiac index *AVD or VO2 = CO × (CaO2 - CvO2) ~ CB × Hb × 1,34 × (SaO2 - SvO2) / 100)

    Measured: 1 year

  4. 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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2023
  2. Study start22 Jan 2022
  3. Primary completion19 Nov 2022
  4. Study completion26 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05693428
Sponsor's protocol ID
1
Status last verified
Jan 2023
First submitted
16 Dec 2022
Last updated
23 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Propofol, Isoflurane and Sevoflurane in people with CHD - Coronary Heart Disease, run by Astana Medical University at 1 site in Kazakhstan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiac index (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.

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