A Phase 1 interventional study of Propofol and Isoflurane in Mitral Valve Insufficiency, Aortic Valve Insufficiency and Cardiac Disease, sponsored by Astana Medical University. Completed at 1 site in Kazakhstan. Open to participants aged 50 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-06-05.
Sponsored by Astana Medical University · Phase 1, Interventional, and Other
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.
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.
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Exclusion Criteria:
Anesthesia
Drug: Propofol
Anesthesia
Drug: Isoflurane
Anesthesia
Drug: Sevoflurane
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
Also known as: Propofol;
В качестве анестетика использовали изофлуран - 1,1-1,2 MAC.
в качестве анестетика использовали севофлуран в дозе - 1,7-1,9 ПДК.
Troponin I
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.
Time frame: 2 year
С-reactive protein
С-reactive protein concentrations in plasma were determined using the biochemical analyzer Biosystems BA-200 (Spanish company, Barcelona) according to the manufacturer's instructions.
Time frame: 2 year
Plan to share: No
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Astana Medical University