NCT05742789

Effect of Anesthetics on Troponin I and С-reactive Protein

Effect of Anesthetics on Troponin I and С-reactive Protein in Mitral, Tricuspid and Aortic Valve Replacement/Plastic in Adult: a Randomized Clinical Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: Astana Medical University · Academic / Other
• Sex: All
• Age: 50 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mitral Valve Insufficiency
• Aortic Valve Insufficiency
• Cardiac Disease

Interventions

Type	Name	Description
DRUG	Propofol	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
DRUG	Isoflurane	В качестве анестетика использовали изофлуран - 1,1-1,2 MAC.
DRUG	Sevoflurane	в качестве анестетика использовали севофлуран в дозе - 1,7-1,9 ПДК.

Timeline

• Start date: 2021-11-30
• Primary completion: 2023-01-04
• Completion: 2023-01-09
• First posted: 2023-02-24
• Last updated: 2023-06-05

Locations

1 site across 1 country: Kazakhstan