AnesthesiaNCT05662163
Effect of General Anesthesia Method on Cardiac Risk Patients on Ischemia Modified Markers
A study testing TIVA and GENERAL ANESTHESIA in people with Anesthesia, run by Ataturk University.
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 Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- TIVA and GENERAL ANESTHESIA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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
Read the 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.
- Conditions
- Anesthesia
- Being tested
- TIVA, GENERAL ANESTHESIA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIVAProcedure or surgery
Anesthesia will be maintained with propofol (6-10 mg/kg/hour) and remifentanil (0.1-0.3 μg/kg/min).
GENERAL ANESTHESIAProcedure or surgery
Anesthesia will be maintained with sevoflurane (2 ml/min) 50% oxygen and remifentanil (0.1-0.3 μg/kg/min).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: GENERAL ANESTHESIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing serum levels of ischemia modified albumin
serum levels of ischemia modified albumin (in terms of IU/ML)
Measured: intraoperative period
comparing serum levels of heart fatty acid binding protein
serum levels of heart fatty acid binding protein (in terms of mcg/L)
Measured: intraoperative period
Secondary outcomes (1)
The effect of anesthesia method used in cardiac risk patients in terms of ephedrine consumption
used ephedrine amount (mg)
Measured: intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start30 Dec 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur Dostbil, Ataturk University
- Investigators
- Canan Atalat, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662163
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/296
- Status last verified
- Dec 2022
- First submitted
- 6 Sep 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05662163
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/296
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 30 Dec 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP TIVA | Active comparator | Procedure: TIVAAnesthesia 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. |
| GROUP INHALATION ANESTHESIA | Active comparator | Procedure: GENERAL ANESTHESIAAnesthesia 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIVAAnesthesia will be maintained with propofol (6-10 mg/kg/hour) and remifentanil (0.1-0.3 μg/kg/min). | Procedure or surgery | GROUP TIVA |
| GENERAL ANESTHESIAAnesthesia will be maintained with sevoflurane (2 ml/min) 50% oxygen and remifentanil (0.1-0.3 μg/kg/min). | Procedure or surgery | GROUP INHALATION ANESTHESIA |
Primary outcome
comparing serum levels of ischemia modified albumin
Time frame: intraoperative period
serum levels of ischemia modified albumin (in terms of IU/ML)
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)
1 secondary outcome
The effect of anesthesia method used in cardiac risk patients in terms of ephedrine consumption
Time frame: intraoperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Canan Atalat study director
Ataturk University
Questions about this trial
What is this clinical trial studying?
A study testing TIVA and GENERAL ANESTHESIA in people with Anesthesia, run by Ataturk University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayşenur Dostbil (+905333677796, adostbil@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparing serum levels of ischemia modified albumin (time frame: intraoperative period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.