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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05662163
Other study ID # B.30.2.ATA.0.01.00/296
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 30, 2022
Est. completion date December 30, 2023

Study information

Verified date December 2022
Source Ataturk University
Contact Aysenur Dostbil
Phone +905333677796
Email adostbil@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date December 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
TIVA
Anesthesia will be maintained with propofol (6-10 mg/kg/hour) and remifentanil (0.1-0.3 µg/kg/min).
GENERAL ANESTHESIA
Anesthesia will be maintained with sevoflurane (2 ml/min) 50% oxygen and remifentanil (0.1-0.3 µg/kg/min).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Outcome

Type Measure Description Time frame Safety issue
Primary comparing serum levels of ischemia modified albumin serum levels of ischemia modified albumin (in terms of IU/ML) intraoperative period
Primary comparing serum levels of heart fatty acid binding protein serum levels of heart fatty acid binding protein (in terms of mcg/L) intraoperative period
Secondary The effect of anesthesia method used in cardiac risk patients in terms of ephedrine consumption used ephedrine amount (mg) intraoperative period
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