NCT05742789

Brief Summary

Abstract Troponin is one of the cardiac biomarkers and its high level correlates to high risk of cardiac myocytes damage. C-reactive protein (CRP) in cardiosurgery participates in the Systemic Inflammation Response Syndrome, and heart-lung apparatus is a powerful stimulator of the systemic inflammatory reaction. Objective: To assess effect of anesthetics on troponin I and СRP in mitral, tricuspid and aortic valve replacement/plastic in adult. Methods. Single-center prospective randomized controlled clinical study. A total of 95 patients were assigned randomly into three groups according to the type of anesthesia: the first group of 32 patients with propofol, the second group with sevoflurane - 32 patients, and the last - 31 patients were with isoflurane. Levels of the cardiac troponin I were calculated in ng/ml с using a portable fluorometric analyzer I-CHROMAII, manufacture of BoditechMedInc (South Korea). Normal range: \<0.04 ng/ml. CRP concentration in plasma has been determined using a biochemical analyzer Biosystems BA-200 (Spanish company, Barcelona) according to the manufacturer's instructions. The normal level of CRP is less than 5 mg/l.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
255

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
Last Updated

June 5, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

February 15, 2023

Last Update Submit

June 1, 2023

Conditions

Mitral Valve InsufficiencyAortic Valve InsufficiencyCardiac Disease

Keywords

Mitral Valve InsufficiencyAortic Valve InsufficiencyTroponin Ipropofolisofluranesevoflurane

Outcome Measures

Primary Outcomes (2)

  • Troponin I

    Cardiac troponin I levels were calculated in ng/mL using the i-CHROMAII portable fluorescent analyzer manufactured by BoditechMedInc. (South Korea). Normal range: \<0.4 ng/mL.

    2 year

  • С-reactive protein

    С-reactive protein concentrations in plasma were determined using the biochemical analyzer Biosystems BA-200 (Spanish company, Barcelona) according to the manufacturer's instructions.

    2 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 4-6 mg/kg/h intravenously on a perfusor

Also known as: Propofol;
Propofol
IsofluraneDRUG

В качестве анестетика использовали изофлуран - 1,1-1,2 MAC.

Isofluran
SevofluraneDRUG

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

Sevofluran

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The age is between 50-65 years old;
  • Mitral and aortic valve insufficiency grade 3-4;
  • Participants of both sexes will be included in the study;
  • Planned surgical interventions;
  • Signed informed consent.

You may not qualify if:

  • pregnancy (risk to the baby and mother)
  • hypertensive disease
  • coronary artery disease;
  • 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 InsufficiencyHeart Diseases

Interventions

PropofolIsofluraneSevoflurane

Condition Hierarchy (Ancestors)

Heart Valve DiseasesCardiovascular DiseasesAortic Valve Disease

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, 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

February 15, 2023

First Posted

February 24, 2023

Study Start

November 30, 2021

Primary Completion

January 4, 2023

Study Completion

January 9, 2023

Last Updated

June 5, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

KA(1)