NCT05696509

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 effect of anesthetics on clinical outcome after mitral and aortic valve replacement in adults. Methods. The data of 75 patients operated in the Cardiosurgery Department of the Medical Center Hospital of the Presidential Administration of the Republic of Kazakhstan were included in the study. All patients underwent mitral, aortic valve replacement/plasty under cardiopulmonary bypass (CPB) conditions. All patients were divided into 3 groups according to the type of anaesthesia: the first (1) group patients anaesthetised with propofol (P), the second group with sevoflurane (S), and the last one is with isoflurane (I). To maintain anaesthesia in Group 1 propofol was used as anaesthetic in a dose of 6 mg/kg/h intravenously on perfusion. In Group 2 the anaesthetic used was sevoflurane in a dose of 1.7-1.9 MAC. Group 3 used isoflurane in the dose of 1.1-1.2 MAC as anaesthetic. Statistical analysis was done by the method of single factor analysis of variance and Kruskal Wallis criterion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2020

Typical duration for phase_3

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 3, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2022

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

2.8 years

First QC Date

December 21, 2022

Last Update Submit

January 13, 2023

Conditions

Mitral Valve InsufficiencyAortic Valve Insufficiency

Keywords

clinical outcomesevofluraneisofluranepropofolMitral Valve InsufficiencyAortic Valve Insufficiency

Outcome Measures

Primary Outcomes (3)

  • cardiac index

    The cardiac stroke (CS) volume was determined by transthoracic echocardiography (CS=end diastolic volume-end systolic volume). There were also determined the cardiac output (CO=CS x heart rate), 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), oxygen utilization factor (KYO2) = VO2 / DO2 × 100 = \[(CaO2 - CvO2) / CaO2\] × 100.

    1 year

  • Oxygen delivery

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

    1 year

Study Arms (3)

Propofol

OTHER

Anesthetic

Drug: Propofol

Isofluran

OTHER

Anesthetic

Drug: Isoflurane

Sevofluran

OTHER

Anesthetic

Drug: Sevoflurane

Interventions

PropofolDRUG

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: Anesthesia
Propofol
IsofluraneDRUG

Isoflurane was used as an anaesthetic in a dose of - 1.1-1.2 MAC

Also known as: Anesthesia
Isofluran
SevofluraneDRUG

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

Also known as: Anesthesia
Sevofluran

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bekzat

Astana, 0.00001, Kazakhstan

Location

MeSH Terms

Conditions

Mitral Valve InsufficiencyAortic Valve Insufficiency

Interventions

PropofolAnesthesiaIsofluraneSevoflurane

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesAortic Valve Disease

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAnesthesia and AnalgesiaMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Alibek Kh Mustafin, Professor

    Astana Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
2nd year doctoral student, anesthesiologist, resuscitator

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 25, 2023

Study Start

January 3, 2020

Primary Completion

October 13, 2022

Study Completion

October 16, 2022

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

To study the effect of anesthetics on clinical outcome after mitral and aortic valve replacement in adults.

Locations

KA(1)