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Effect of Anesthetics on Troponin I and С-reactive Protein

A

Astana Medical University

Status and phase

Completed
Phase 1

Conditions

Mitral Valve Insufficiency
Cardiac Disease
Aortic Valve Insufficiency

Treatments

Drug: Sevoflurane
Drug: Propofol
Drug: Isoflurane

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full description

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.

Enrollment

255 patients

Sex

All

Ages

50 to 65 years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

255 participants in 3 patient groups

Propofol
Other group
Description:
Anesthesia
Treatment:
Drug: Propofol
Isofluran
Other group
Description:
Anesthesia
Treatment:
Drug: Isoflurane
Sevofluran
Other group
Description:
Anesthesia
Treatment:
Drug: Sevoflurane

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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