Coronary Artery DiseaseNCT06209437
Anesthesia Management of Coronary Artery Bypass Surgery and Inflammatory Biomarkers
An observational study of Coronary Artery Disease and Postoperative Complications, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to evaluate effect of total intravenous anesthesia or inhalation anesthesia on inflammatory biomarkers in coronary artery bypass surgery and their relationship with early postoperative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Postoperative Complications, Anesthesia
- Type of treatment
- Injection or infusion
- How many people
- 228 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jan 2024to 1 Jun 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ASA (American Society of Anesthesiologists) II- III patients over the age of 18 who will undergo on-pump bypass surgery in Ankara City Hospital Bilkent and who agree to participate in the study
Who may be able to join
- On-pump bypass surgery
- Del-Nido cardioplegia used in operation
- ASA (American Society of Anesthesiologists) II- III patients
Who cannot join
- Patients with active malignancy
- Diagnosed with systemic inflammatory disease or autoimmune disease
- Chronic liver and kidney disease
- History of cerebrovascular disease within 6 months
- EF (Ejection Fraction) < 45%
- Non-cooperative or patients who do not agree to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara city hospital bilkent
Ankara, Çankaya, 06800
About this study
Official title: The Effect of Total Intravenous Anesthesia or Inhalation Anesthesia on Inflammatory Biomarkers in Coronary Artery Bypass Surgery and Their Relationship With Early Postoperative Complications a Prospective Observational Study
The goal of this observational study is to evaluate effect of total intravenous anesthesia or inhalation anesthesia on inflammatory biomarkers in coronary artery bypass surgery and their relationship with early postoperative complications. The main questions it aims to answer are
- Does the type of anesthesia have a relationship with inflammatory biomarkers?
- Are inflammatory biomarkers associated with postoperative complications?
Read the detailed description
This study is planned to be a prospective observational clinical study. Patients who will undergo on-pump coronary artery bypass surgery, meet the eligibility criteria and agree to participate in the study and sign the informed patient consent form will be included in the study.Systemic immune inflammatory index, systemic inflammatory response index, neurophile lymphocyte ratio, platelet lymphocyte ratio will be calculated in the routine complete blood count of patients in the last 3 preoperative days and in the first 24 hours postoperatively.It will be evaluated whether these biomarkers are related to the anesthesia technique used, patients comorbidities and the complications that develop in the first 24 hours postoperatively. Patients will be evaluated preoperatively, intraoperatively and postoperatively; preoperative comorbidities, intraoperative anesthesia management, cross clamp, pump and surgery times, blood and blood product transfusion, inotrope use and complications that develop up to the first 24 hours postoperatively will be recorded.The anesthetic technique to be used will be determined according to the anesthesiologist's preference and will be recorded.
- Medical subject headings
- Coronary Artery Disease, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inhalation Anesthesia Group | After induction, anesthesia will be provided with sevoflurane (2.0 mac) and intravenous remifentanil infusion (0.05-0.2 mcg/kg/min). Depth of anesthesia will be evaluated with Bispectral Index (BIS). | |
| Total Intravenous Anesthesia Group | After induction, anesthesia will be provided with intravenous propofol infusion (50-150 mcg/kg/min) and intravenous remifentanil infusion (0.05-0.2 mcg/kg/min). Depth of anesthesia will be evaluated with Bispectral Index (BIS). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative systemic immune inflammatory index (SII)
It will be calculated as: platelet count x neutrophil count / lymphocyte count from routine complete blood count
Measured: within 3 days preoperatively
Postoperative systemic immune inflammatory index (SII)
It will be calculated as: platelet count x neutrophil count / lymphocyte count from routine complete blood count
Measured: in the first 24 hours postoperatively
Preoperative systemic inflammatory response index (SIRI)
It will be calculated as: neutrophil count x monocyte count/lymphocyte count from routine complete blood count
Measured: within 3 days preoperatively
Postoperative systemic inflammatory response index (SIRI)
It will be calculated as: neutrophil count x monocyte count/lymphocyte count from routine complete blood count
Measured: in the first 24 hours postoperatively
Preoperative neutrophile lymphocyte ratio (NLR)
It will be calculated as:neutrophil count/lymphocyte count from routine complete blood count
Measured: within 3 days preoperatively
Postoperative neutrophile lymphocyte ratio (NLR)
It will be calculated as:neutrophil count/lymphocyte count from routine complete blood count
Measured: in the first 24 hours postoperatively
Preoperative platelet lymphocyte ratio (PLR)
It will be calculated as: platelet count/lymphocyte count from routine complete blood count
Measured: within 3 days preoperatively
Postoperative platelet lymphocyte ratio (PLR)
It will be calculated as: platelet count/lymphocyte count from routine complete blood count
Measured: in the first 24 hours postoperatively
Preoperative c-reactive protein
from routine preoperative blood sample ( milligram/decilitre)
Measured: within 3 days preoperatively
Preoperative procalcitonin
from routine preoperative blood sample ( microgram/litre)
Measured: within 3 days preoperatively
Postoperative c-reactive protein
from routine postoperative blood sample ( milligram/decilitre)
Measured: in the first 24 hours postoperatively
Postoperative procalcitonin
from routine postoperative blood sample ( microgram/litre)
Measured: in the first 24 hours postoperatively
Postoperative complications
Postoperative complications consisting of:
- newly developed atrial fibrillation
- need for cardiac pacing
- need for ECMO (Extracorporeal membrane oxygenation)
- need for IABP (Intra-Aortic Balloon Pump)
- prolonged mechanical ventilation
- pericardial effusion
- cardiac arrest
- cerebrovascular event
- delirium
- exitus
- other complications.
Measured: within the first 24 hours after surgery
Secondary outcomes (3)
Patient comorbidities
Patient comorbidities will be assessed
Measured: preoperative within 48 hours
Transfusion requirement
Incidence of transfusion of blood and blood products to the patient
Measured: during the operation
Inotrope requirement
Incidence of inotrope usage, inotropes consisting of:
- noradrenaline
- dopamine
- dobutamine
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start8 Jan 2024
- Primary completion1 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209437
- Sponsor's protocol ID
- volgaozkan1
- Status last verified
- Jun 2024
- First submitted
- 5 Jan 2024
- Last updated
- 4 Jun 2024
- 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 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Total Intravenous Anesthesia or Inhalation Anesthesia on Inflammatory Biomarkers in Coronary Artery Bypass Surgery and Their Relationship With Early Postoperative Complications a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06209437
- Acronym / sponsor ID
- volgaozkan1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 17 Jan 2024 (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.
The goal of this observational study is to evaluate effect of total intravenous anesthesia or inhalation anesthesia on inflammatory biomarkers in coronary artery bypass surgery and their relationship with early postoperative complications. The main questions it aims to answer are
- Does the type of anesthesia have a relationship with inflammatory biomarkers?
- Are inflammatory biomarkers associated with postoperative complications?
Detailed description
This study is planned to be a prospective observational clinical study. Patients who will undergo on-pump coronary artery bypass surgery, meet the eligibility criteria and agree to participate in the study and sign the informed patient consent form will be included in the study.Systemic immune inflammatory index, systemic inflammatory response index, neurophile lymphocyte ratio, platelet lymphocyte ratio will be calculated in the routine complete blood count of patients in the last 3 preoperative days and in the first 24 hours postoperatively.It will be evaluated whether these biomarkers are related to the anesthesia technique used, patients comorbidities and the complications that develop in the first 24 hours postoperatively. Patients will be evaluated preoperatively, intraoperatively and postoperatively; preoperative comorbidities, intraoperative anesthesia management, cross clamp, pump and surgery times, blood and blood product transfusion, inotrope use and complications that develop up to the first 24 hours postoperatively will be recorded.The anesthetic technique to be used will be determined according to the anesthesiologist's preference and will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhalation Anesthesia Group | – | –After induction, anesthesia will be provided with sevoflurane (2.0 mac) and intravenous remifentanil infusion (0.05-0.2 mcg/kg/min). Depth of anesthesia will be evaluated with Bispectral Index (BIS). |
| Total Intravenous Anesthesia Group | – | –After induction, anesthesia will be provided with intravenous propofol infusion (50-150 mcg/kg/min) and intravenous remifentanil infusion (0.05-0.2 mcg/kg/min). Depth of anesthesia will be evaluated with Bispectral Index (BIS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ASA (American Society of Anesthesiologists) II- III patients over the age of 18 who will undergo on-pump bypass surgery in Ankara City Hospital Bilkent and who agree to participate in the study
Key inclusion criteria (3 listed)
- On-pump bypass surgery
- Del-Nido cardioplegia used in operation
- ASA (American Society of Anesthesiologists) II- III patients
Key exclusion criteria (6 listed)
- Patients with active malignancy
- Diagnosed with systemic inflammatory disease or autoimmune disease
- Chronic liver and kidney disease
- History of cerebrovascular disease within 6 months
- EF (Ejection Fraction) < 45%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preoperative systemic immune inflammatory index (SII)
Time frame: within 3 days preoperatively
It will be calculated as: platelet count x neutrophil count / lymphocyte count from routine complete blood count
Postoperative systemic immune inflammatory index (SII)
Time frame: in the first 24 hours postoperatively
It will be calculated as: platelet count x neutrophil count / lymphocyte count from routine complete blood count
Preoperative systemic inflammatory response index (SIRI)
Time frame: within 3 days preoperatively
It will be calculated as: neutrophil count x monocyte count/lymphocyte count from routine complete blood count
Postoperative systemic inflammatory response index (SIRI)
Time frame: in the first 24 hours postoperatively
It will be calculated as: neutrophil count x monocyte count/lymphocyte count from routine complete blood count
Preoperative neutrophile lymphocyte ratio (NLR)
Time frame: within 3 days preoperatively
It will be calculated as:neutrophil count/lymphocyte count from routine complete blood count
Postoperative neutrophile lymphocyte ratio (NLR)
Time frame: in the first 24 hours postoperatively
It will be calculated as:neutrophil count/lymphocyte count from routine complete blood count
Preoperative platelet lymphocyte ratio (PLR)
Time frame: within 3 days preoperatively
It will be calculated as: platelet count/lymphocyte count from routine complete blood count
Postoperative platelet lymphocyte ratio (PLR)
Time frame: in the first 24 hours postoperatively
It will be calculated as: platelet count/lymphocyte count from routine complete blood count
Preoperative c-reactive protein
Time frame: within 3 days preoperatively
from routine preoperative blood sample ( milligram/decilitre)
Preoperative procalcitonin
Time frame: within 3 days preoperatively
from routine preoperative blood sample ( microgram/litre)
Postoperative c-reactive protein
Time frame: in the first 24 hours postoperatively
from routine postoperative blood sample ( milligram/decilitre)
Postoperative procalcitonin
Time frame: in the first 24 hours postoperatively
from routine postoperative blood sample ( microgram/litre)
Postoperative complications
Time frame: within the first 24 hours after surgery
Postoperative complications consisting of: * newly developed atrial fibrillation * need for cardiac pacing * need for ECMO (Extracorporeal membrane oxygenation) * need for IABP (Intra-Aortic Balloon Pump) * prolonged mechanical ventilation * pericardial effusion * cardiac arrest * cerebrovascular event * delirium * exitus * other complications.
3 secondary outcomes
Patient comorbidities
Time frame: preoperative within 48 hours
Transfusion requirement
Time frame: during the operation
Inotrope requirement
Time frame: during the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Postoperative Complications, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative systemic immune inflammatory index (SII) (time frame: within 3 days preoperatively). The study lists 13 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 4 Jun 2024.