NCT05693428

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

10 months

First QC Date

December 16, 2022

Last Update Submit

January 11, 2023

Conditions

CHD - Coronary Heart Disease

Keywords

sevofluraneisofluranepropofolOxygen consumptionenergy expenditureoxygen transportmetabolic status

Outcome Measures

Primary Outcomes (4)

  • 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.

    1 year

  • Oxygen transport

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

    1 year

  • Oxygen consumption

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

    1 year

  • 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

    1 year

Study Arms (3)

Propofol

OTHER

Anesthesia

Drug: Propofol

Isofluran

OTHER

Anesthesia

Drug: Isoflurane

Sevofluran

OTHER

Anesthesia

Drug: Sevoflurane

Interventions

PropofolDRUG

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.

Also known as: Propofol;
Propofol
IsofluraneDRUG

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

Isofluran
SevofluraneDRUG

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

Sevofluran

Eligibility Criteria

Age45 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bekzat

Astana, 0.00001, Kazakhstan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

PropofolIsofluraneSevoflurane

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Alibek Kh Mustafin, Professor

    Astana Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
2nd year doctoral student, anesthesiologist, resuscitator

Study Record Dates

First Submitted

December 16, 2022

First Posted

January 23, 2023

Study Start

January 22, 2022

Primary Completion

November 19, 2022

Study Completion

November 26, 2022

Last Updated

January 23, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

KA(1)