Clinical trial NCT05742789: Effect of Anesthetics on Troponin I and С-reactive Protein
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mitral Valve Insufficiency
Aortic Valve Insufficiency
Cardiac Disease
Keywords: Mitral Valve Insufficiency
Aortic Valve Insufficiency
Troponin I
propofol
isoflurane
sevoflurane
Lead sponsor: Astana Medical University
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 255
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Troponin I
timeFrame: 2 year
measure: С-reactive protein
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Astana
country: Kazakhstan
facility: Bekzat
Study officials:
affiliation: Astana Medical University
name: Alibek Kh Mustafin, Professor
role: STUDY_DIRECTOR
References: