The Effects of Sevoflurane, Isoflurane and Propofol During Cardiac Surgery

NCT05695287 | Completed Phase 1

• 1 other identifier: 10
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Mitral Valve Insufficiency; Aortic Valve Insufficiency

Keywords

heart valve; CHD; sevoflurane; propofol; isoflurane

Outcome Measures

Primary Outcomes (4)

• cardiac index

  cardiac index (CI=CO/body surface area

  1 year

• Oxygen consumption

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

  1 year

• Oxygen delivery

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

  1 year

• cardiac stroke

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

  1 year

Study Arms (3)

Propofol

OTHER

Anesthesia

Drug: Propofol

Isofluran

OTHER

Anesthesia

Drug: Isoflurane

Sevofluran

OTHER

Anesthesia

Drug: Sevoflurane

Interventions

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

Also known as: Propofol;

Propofol

Isoflurane DRUG

Isoflurane

Also known as: В качестве анестетика использовали изофлуран - 1,1-1,2 ПДК.

Isofluran

Sevoflurane DRUG

Sevoflurane

Also known as: в качестве анестетика использовали севофлуран в дозе - 1,7-1,9 ПДК.

Sevofluran

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Astana Medical University: lead

Study Sites (1)

Bekzat

Astana, 0.00001, Kazakhstan

Location

MeSH Terms

Conditions

Coronary Artery Disease; Mitral Valve Insufficiency; Aortic Valve Insufficiency

Interventions

Propofol; Isoflurane; Sevoflurane

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Heart Valve Diseases; Aortic Valve Disease

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Alibek Kh Mustafin, Professor

  Astana Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 25, 2023
• Study Start: January 22, 2021
• Primary Completion: November 19, 2022
• Study Completion: December 16, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)