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Effect of General Anesthesia Method on Cardiac Risk Patients on Ischemia Modified Markers

Primary Purpose

Anesthesia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TIVA
GENERAL ANESTHESIA
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Anesthesia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Being 18 years or older Getting a score of 2 and above according to the Lee cardiac index Having a non-cardiac surgical procedure that will take at least three hours ASA II or III Exclusion Criteria: Under 18 years old Those who refused to participate in the study Patients with chronic renal failure Patients with creatinine value ≥ 1.5 mg/dl Surgery that takes less than 3 hours Patients with liver failure Refusing to participate in the study Being allergic to the drugs used

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    GROUP TIVA

    GROUP INHALATION ANESTHESIA

    Arm Description

    Anesthesia will be maintained with propofol (6-10 mg/kg/hour) and remifentanil (0.1-0.3 μg/kg/min). Blood will be taken from the patients at 0, 1 and 4 hours, centrifuged and stored at -80 degrees. From these examples, CK, CKMB, HIGH SENSITIVE TROPONIN, HFABP, IMA AND ALBUMIN will be studied.

    Anesthesia will be maintained with sevoflurane (2 ml/min) 50% oxygen and remifentanil (0.1-0.3 μg/kg/min). Blood will be taken from the patients at 0, 1 and 4 hours, centrifuged and stored at -80 degrees. From these examples, CK, CKMB, HIGH SENSITIVE TROPONIN, HFABP, IMA AND ALBUMIN will be studied.

    Outcomes

    Primary Outcome Measures

    comparing serum levels of ischemia modified albumin
    serum levels of ischemia modified albumin (in terms of IU/ML)
    comparing serum levels of heart fatty acid binding protein
    serum levels of heart fatty acid binding protein (in terms of mcg/L)

    Secondary Outcome Measures

    The effect of anesthesia method used in cardiac risk patients in terms of ephedrine consumption
    used ephedrine amount (mg)

    Full Information

    First Posted
    September 6, 2022
    Last Updated
    December 14, 2022
    Sponsor
    Ataturk University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05662163
    Brief Title
    Effect of General Anesthesia Method on Cardiac Risk Patients on Ischemia Modified Markers
    Official Title
    Effect of General Anesthesia Method Chosen in Non-cardiac Surgery of Cardiac Risk Patients on Ischemia Modified Albumin and Heart-Type Fatty Acid-Binding Protein (H-FABP) Levels
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 30, 2022 (Anticipated)
    Primary Completion Date
    June 30, 2023 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ataturk 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
    To examine the effects of the general anesthesia method chosen in non-cardiac surgical operations of patients with cardiac risk on the levels of cardiac markers
    Detailed Description
    To examine the effects of the general anesthesia method chosen in non-cardiac surgical operations of patients with cardiac risk on the levels of cardiac markers like; serum levels of the Creatine Kinase, Creatine Kinase Myocardial Band, high sensitive troponin, heart-type fatty acid-binding protein, ischemia-modified albumin and albumin. And evaluate the effect of anesthesia method on haemodynamic.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anesthesia

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    GROUP TIVA
    Arm Type
    Active Comparator
    Arm Description
    Anesthesia will be maintained with propofol (6-10 mg/kg/hour) and remifentanil (0.1-0.3 μg/kg/min). Blood will be taken from the patients at 0, 1 and 4 hours, centrifuged and stored at -80 degrees. From these examples, CK, CKMB, HIGH SENSITIVE TROPONIN, HFABP, IMA AND ALBUMIN will be studied.
    Arm Title
    GROUP INHALATION ANESTHESIA
    Arm Type
    Active Comparator
    Arm Description
    Anesthesia will be maintained with sevoflurane (2 ml/min) 50% oxygen and remifentanil (0.1-0.3 μg/kg/min). Blood will be taken from the patients at 0, 1 and 4 hours, centrifuged and stored at -80 degrees. From these examples, CK, CKMB, HIGH SENSITIVE TROPONIN, HFABP, IMA AND ALBUMIN will be studied.
    Intervention Type
    Procedure
    Intervention Name(s)
    TIVA
    Intervention Description
    Anesthesia will be maintained with propofol (6-10 mg/kg/hour) and remifentanil (0.1-0.3 μg/kg/min).
    Intervention Type
    Procedure
    Intervention Name(s)
    GENERAL ANESTHESIA
    Intervention Description
    Anesthesia will be maintained with sevoflurane (2 ml/min) 50% oxygen and remifentanil (0.1-0.3 μg/kg/min).
    Primary Outcome Measure Information:
    Title
    comparing serum levels of ischemia modified albumin
    Description
    serum levels of ischemia modified albumin (in terms of IU/ML)
    Time Frame
    intraoperative period
    Title
    comparing serum levels of heart fatty acid binding protein
    Description
    serum levels of heart fatty acid binding protein (in terms of mcg/L)
    Time Frame
    intraoperative period
    Secondary Outcome Measure Information:
    Title
    The effect of anesthesia method used in cardiac risk patients in terms of ephedrine consumption
    Description
    used ephedrine amount (mg)
    Time Frame
    intraoperative period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Being 18 years or older Getting a score of 2 and above according to the Lee cardiac index Having a non-cardiac surgical procedure that will take at least three hours ASA II or III Exclusion Criteria: Under 18 years old Those who refused to participate in the study Patients with chronic renal failure Patients with creatinine value ≥ 1.5 mg/dl Surgery that takes less than 3 hours Patients with liver failure Refusing to participate in the study Being allergic to the drugs used
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ayşenur Dostbil
    Phone
    +905333677796
    Email
    adostbil@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Canan Atalay
    Phone
    +905333635318
    Email
    cananatalay@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Canan Atalat
    Organizational Affiliation
    Atatürk University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of General Anesthesia Method on Cardiac Risk Patients on Ischemia Modified Markers

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