Effect of Anesthetics on Troponin I and С-reactive Protein

NCT ID: NCT05742789

Last Updated: 2023-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 255 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2023-01-09

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.

Conditions

Mitral Valve Insufficiency; Aortic Valve Insufficiency; Cardiac Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Propofol

Anesthesia

Group Type: OTHER

Propofol

Intervention Type: DRUG

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

Isofluran

Anesthesia

Group Type: OTHER

Isoflurane

Intervention Type: DRUG

В качестве анестетика использовали изофлуран - 1,1-1,2 MAC.

Sevofluran

Anesthesia

Group Type: OTHER

Sevoflurane

Intervention Type: DRUG

в качестве анестетика использовали севофлуран в дозе - 1,7-1,9 ПДК.

Interventions

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

Intervention Type: DRUG

Isoflurane

В качестве анестетика использовали изофлуран - 1,1-1,2 MAC.

Intervention Type: DRUG

Sevoflurane

в качестве анестетика использовали севофлуран в дозе - 1,7-1,9 ПДК.

Intervention Type: DRUG

Other Intervention Names

Propofol;

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;

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astana Medical University

OTHER

Sponsor Role: lead

Responsible Party

Bekzat Baiterek

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alibek Kh Mustafin, Professor

Role: STUDY_DIRECTOR

Astana Medical University

Locations

Bekzat

Astana, , Kazakhstan

Countries

Kazakhstan

Other Identifiers

6

Identifier Type: -

Identifier Source: org_study_id