Effect of Anesthetics on Troponin I and С-reactive Protein
- Conditions
- Mitral Valve InsufficiencyCardiac DiseaseAortic Valve Insufficiency
- Interventions
- Registration Number
- NCT05742789
- Lead Sponsor
- Astana Medical University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 255
- 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.
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sevofluran Sevoflurane Anesthesia Propofol Propofol Anesthesia Isofluran Isoflurane Anesthesia
- Primary Outcome Measures
Name Time Method Troponin I 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.
С-reactive protein 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Bekzat
🇰🇿Astana, Kazakhstan