NCT05662163

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 22, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

December 30, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

December 22, 2022

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

September 6, 2022

Last Update Submit

December 14, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • comparing serum levels of ischemia modified albumin

    serum levels of ischemia modified albumin (in terms of IU/ML)

    intraoperative period

  • 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 Outcomes (1)

  • The effect of anesthesia method used in cardiac risk patients in terms of ephedrine consumption

    intraoperative period

Study Arms (2)

GROUP TIVA

ACTIVE COMPARATOR

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

GROUP INHALATION ANESTHESIA

ACTIVE COMPARATOR

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

Interventions

TIVAPROCEDURE

Anesthesia will be maintained with propofol (6-10 mg/kg/hour) and remifentanil (0.1-0.3 μg/kg/min).

GROUP TIVA

Anesthesia will be maintained with sevoflurane (2 ml/min) 50% oxygen and remifentanil (0.1-0.3 μg/kg/min).

GROUP INHALATION ANESTHESIA

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Canan Atalat

    Ataturk University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 6, 2022

First Posted

December 22, 2022

Study Start

December 30, 2022

Primary Completion

June 30, 2023

Study Completion

December 30, 2023

Last Updated

December 22, 2022

Record last verified: 2022-12