Effect of Anesthetics on Cardiac Biomarkers in Mitral and Aortic Valve Replacement/Plasty

Sponsor

Astana Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT05742789

Collaborator

(none)

255

Enrollment

Location

Arms

13.3

Actual Duration (Months)

19.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Abstract Cardiac troponin is one of the biomarkers of the heart, and its high level correlates with a high risk of damage to cardiomyocytes.

Objective: To determine the effect of anesthetics on cardiac enzymes during mitral and aortic valve replacement in adults.

methods. Single-center prospective randomized controlled clinical study. A total of 255 patients were assigned randomly into three groups according to the type of anesthesia: the first group of 85 patients with propofol, the second group with sevoflurane - 85 patients, and the last - 85 patients were with isoflurane.

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. Cardiac index (CI=CO/body surface area), oxygen consumption (VO2 = Cardiac index (CI)*AVD or VO2 = CO × (CaO2 - CvO2) ~ CO × Hb × 1.34 × (SaO2 - SvO2) / 100) were determined before induction into anesthesia.

Condition or Disease	Intervention/Treatment	Phase
Mitral Valve Insufficiency Aortic Valve Insufficiency Cardiac Disease	Drug: Propofol Drug: Isoflurane Drug: Sevoflurane	Phase 1

Detailed Description

The examination and treatment data of 255 patients operated in the Cardiosurgical Department of the Medical Center Hospital of the Presidential Administration of the Republic of Kazakhstan were included in the study. All patients underwent mitral, aortic 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=t2DN/confidence intervalN+t2α, which will allow to identify the static significance of the study.

Inclusion criteria for the main study phase

The age is between 50-60 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; Only elective patients were included in this study. Patients corresponding to class II -III according to the scale American Society of Anesthesiologists (ASA); A total of 255 patients were assigned randomly into three groups according to the type of anesthesia: the first group of 85 patients with propofol, the second group with sevoflurane - 85 patients, and the last - 85 patients were with isoflurane.

Three blood samples were taken from patients before anesthesia, after operations at 6 hours and after operations at 6 hours. Blood samples were taken into sterile tubes that did not contain EDTA and heparin, in order to avoid underestimation of results, centrifuged and stored at -20 °C.

Additionally, cardiac index, oxygen consumption and energy expenditure were determined. We determined these indicators in 3 stages: before the start of anesthesia; after the start of anesthesia; at the end of the operation.

Before induction into anesthesia, hemodynamic monitoring was started on admission to the operating theatre using a Nihon Kohden monitor (Japan). The right radial artery was catheterized for invasive monitoring of systemic arterial pressure and arterial blood sampling, and a catheter was then inserted into the central jugular vein (under ultrasound machine control) and guided into the right atrium for mixed venous blood sampling.

Cardiac index (CI=CO/body surface area), оxygen consumption (VO2 = Cardiac index (CI)*AVD or VO2 = CO × (CaO2 - CvO2) ~ CO × Hb × 1.34 × (SaO2 - SvO2) / 100) were determined before induction into anesthesia.

After tracheal intubation, indirect calorimetry was used to determine VO2, energy expenditure during anesthesia using a Spirometry device (Oxford, UK), which was connected to an endotracheal tube and continuously showed oxygen demand and energy expenditure. Also a transesophageal echocardiography sensor was used to determine cardiac index.

All patients in all groups were anesthetized with fentanyl at a dose of 5-7 µg/kg, ketamine 1.5-2 mg/kg, and propofol 1-1.5 mg/kg intravenously fractionally. Pipecuronium bromide 0.04-0.07 mg/kg was used as muscle relaxant in all patients. 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 (BBRAUN). In Group 2, sevoflurane was used as an anaesthetic in a dose of - 1.7-1.9 MAC. In Group 3 isoflurane was used as the anesthetic in the dose of 1.1-1.2 MAC.

Inhalational anesthetics were used from the beginning of the surgery to the CPB and after CPB until the end of the surgery.

During CPB, propofol at a dose of 6 mg/kg/h intravenously via perfusion was used in all patients in all groups. Anesthesia regimen: fentanyl 100 µg IV every 30 min; myorelaxant pipecuronium bromide 2 mg every 40-60 min. Dobutamine solution was administered at a dose of 5 µg/kg/min intravenously on perfusion after CPB in all patients at the same dosages in all groups.

Statistical analysis was performed using the IBM SPSS Statistics 20 package using the nonparametric Kruskal-Wallis test for independent samples. The Kruskal-Wallis test was used, since this parameter, according to the Kolmogorov and Smirnov test, gave an abnormal distribution.

Study Design

Study Type:

Interventional

Actual Enrollment :

255 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

Effect of Anesthetics on Cardiac Biomarkers in Mitral and Aortic Valve Replacement/Plasty in Adult: a Randomized Clinical Study

Actual Study Start Date :

Nov 30, 2021

Actual Primary Completion Date :

Jan 4, 2023

Actual Study Completion Date :

Jan 9, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Propofol Anesthesia	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 Other Names: Propofol;
Other: Isofluran Anesthesia	Drug: Isoflurane В качестве анестетика использовали изофлуран - 1,1-1,2 MAC.
Other: Sevofluran Anesthesia	Drug: Sevoflurane в качестве анестетика использовали севофлуран в дозе - 1,7-1,9 ПДК.

Arm

Intervention/Treatment

Other: Propofol

Anesthesia

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

Other Names:

Propofol;

Other: Isofluran

Anesthesia

Drug: Isoflurane

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

Other: Sevofluran

Anesthesia

Drug: Sevoflurane

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

Outcome Measures

Primary Outcome Measures

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.
cardiac index [2 year]
cardiac index (CI=CO/body surface area
Oxygen consumption [2 year]
oxygen consumption (VO2 = Cardiac index *AVD or VO2 = CO × (CaO2 - CvO2) ~ CB × Hb × 1,34 × (SaO2 - SvO2) / 100)
energy expenditure [2 year]
After tracheal intubation, indirect calorimetry was used to determine VO2, energy expenditure during anesthesia using a Spirometry device (Oxford, UK), which was connected to an endotracheal tube and continuously showed oxygen demand and energy expenditure.