Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05742789 |
| Other study ID # |
6 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
November 30, 2021 |
| Est. completion date |
January 9, 2023 |
Study information
| Verified date |
June 2023 |
| Source |
Astana Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
