Effect of Anesthetics on Troponin I and С-reactive Protein
Primary Purpose
Mitral Valve Insufficiency, Aortic Valve Insufficiency, Cardiac Disease
Status
Completed
Phase
Phase 1
Locations
Kazakhstan
Study Type
Interventional
Intervention
Propofol
Isoflurane
Sevoflurane
Sponsored by
About this trial
This is an interventional other trial for Mitral Valve Insufficiency focused on measuring Mitral Valve Insufficiency, Aortic Valve Insufficiency, Troponin I, propofol, isoflurane, sevoflurane
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;
Sites / Locations
- Bekzat
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Propofol
Isofluran
Sevofluran
Arm Description
Anesthesia
Anesthesia
Anesthesia
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05742789
First Posted
February 15, 2023
Last Updated
June 1, 2023
Sponsor
Astana Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05742789
Brief Title
Effect of Anesthetics on Troponin I and С-reactive Protein
Official Title
Effect of Anesthetics on Troponin I and С-reactive Protein in Mitral, Tricuspid and Aortic Valve Replacement/Plastic in Adult: a Randomized Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
January 4, 2023 (Actual)
Study Completion Date
January 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Astana Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Insufficiency, Aortic Valve Insufficiency, Cardiac Disease
Keywords
Mitral Valve Insufficiency, Aortic Valve Insufficiency, Troponin I, propofol, isoflurane, sevoflurane
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
255 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propofol
Arm Type
Other
Arm Description
Anesthesia
Arm Title
Isofluran
Arm Type
Other
Arm Description
Anesthesia
Arm Title
Sevofluran
Arm Type
Other
Arm Description
Anesthesia
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Propofol;
Intervention Description
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
Intervention Name(s)
Isoflurane
Intervention Description
В качестве анестетика использовали изофлуран - 1,1-1,2 MAC.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
в качестве анестетика использовали севофлуран в дозе - 1,7-1,9 ПДК.
Primary Outcome Measure Information:
Title
Troponin I
Description
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
Title
С-reactive protein
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alibek Kh Mustafin, Professor
Organizational Affiliation
Astana Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Bekzat
City
Astana
ZIP/Postal Code
0.00001
Country
Kazakhstan
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Anesthetics on Troponin I and С-reactive Protein
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