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NCT Number: NCT05742789

Effect of Anesthetics on Troponin I and С-reactive Protein

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.

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Key information

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bekzat

Astana, 0.00001, Kazakhstan

About this study

The examination and treatment data of 95 patients operated in the departments of cardiovascular surgery of the City multidisciplinary hospital No. 2 were included in the study. All patients underwent mitral, aortic, tricuspid valve replacement/plasty under cardiopulmonary bypass (CPB) conditions. This research work was conducted between 2021 and 2023. To calculate the sample size, we used the formula n=t2*D*N/confidence interval*N+t2*α, which will allow to identify the static significance of the study.

Inclusion criteria

insufficiency of mitral, tricuspid and aortic valves of 3-4th degree; only planned surgeries; age range 40-60 years old; patients corresponding to II-III grade according to the scale of the American Society of Anaesthesiologists.

Exclusion criteria

pregnancy; acute coronary syndrome; hemodynamic instability.

All 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.

The level of cardiac troponin I were calculated in ng/ml using a portable fluorometric analyzer i-CHROMAII, production of BoditechMedInc (South Korea). The normal range: <0.04 ng/ml. The analyzer Triage® Meter Pro of Alere San Diego Inc. production (USA).

Three blood samples were taken in the patients before the anaesthesia, in 12 hours post-surgery and in 48 hours post-surgery. Blood samples were taken in the sterile test-tubes, containing no EDTA and heparin, centrifugated and stored at temperature -20 °С to avoid the erroneously low results.

CRP concentrations in plasma were determined using the 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. Blood samples were taken in the patients before the anaesthesia, 1st day post-surgery, 3rd and 5th days post-surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;

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

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

Sevoflurane

Drug

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

Primary outcomes

  1. Troponin I

    Time frame: 2 year

    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. С-reactive protein

    Time frame: 2 year

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

Sponsors and collaborators

Lead sponsor

Astana Medical University

Other

Registry information

Official study title

Effect of Anesthetics on Troponin I and С-reactive Protein in Mitral, Tricuspid and Aortic Valve Replacement/Plastic in Adult: a Randomized Clinical Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 24, 2023
Registry last updated
Jun 5, 2023

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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