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

December 14, 2022 updated by: Aysenur Dostbil, Ataturk University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GROUP TIVA
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.
Procedure: TIVA
Anesthesia will be maintained with propofol (6-10 mg/kg/hour) and remifentanil (0.1-0.3 μg/kg/min).
Active Comparator: GROUP INHALATION ANESTHESIA
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.
Procedure: GENERAL ANESTHESIA
Anesthesia will be maintained with sevoflurane (2 ml/min) 50% oxygen and remifentanil (0.1-0.3 μg/kg/min).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparing serum levels of ischemia modified albumin
Time Frame: intraoperative period
serum levels of ischemia modified albumin (in terms of IU/ML)
intraoperative period
comparing serum levels of heart fatty acid binding protein
Time Frame: intraoperative period
serum levels of heart fatty acid binding protein (in terms of mcg/L)
intraoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of anesthesia method used in cardiac risk patients in terms of ephedrine consumption
Time Frame: intraoperative period
used ephedrine amount (mg)
intraoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Investigators

  • Study Director: Canan Atalat, Ataturk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 30, 2022

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

September 6, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Actual)

December 22, 2022

Study Record Updates

Last Update Posted (Actual)

December 22, 2022

Last Update Submitted That Met QC Criteria

December 14, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.ATA.0.01.00/296

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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