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Completed

NCT Number: NCT05695287

The Effects of Sevoflurane, Isoflurane and Propofol During Cardiac Surgery

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.

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bekzat

Astana, 0.00001, Kazakhstan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Propofol

Drug

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

Other names: Propofol;

Isoflurane

Drug

Isoflurane

Other names: В качестве анестетика использовали изофлуран - 1,1-1,2 ПДК.

Sevoflurane

Drug

Sevoflurane

Other names: в качестве анестетика использовали севофлуран в дозе - 1,7-1,9 ПДК.

Primary outcomes

  1. cardiac index

    Time frame: 1 year

    cardiac index (CI=CO/body surface area

  2. Oxygen consumption

    Time frame: 1 year

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

  3. Oxygen delivery

    Time frame: 1 year

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

  4. cardiac stroke

    Time frame: 1 year

    The cardiac stroke (CS) volume was determined by transthoracic echocardiography (CS =end diastolic volume-end systolic volume).

Sponsors and collaborators

Lead sponsor

Astana Medical University

Other

Registry information

Official study title

The Effects of Sevoflurane, Isoflurane and Propofol on the Hemodynamic, Body Energy Expenditure During Cardiac Surgery in Adults: a Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 25, 2023
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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