Cardiac AnesthesiaNCT05320341
TIVA Versus Inhalational Anesthesia and Tissue Oxygenation in Cardiac Surgery
An observational study of Cardiac Anesthesia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the effect of total intravenous anesthesia (TIVA) and inhalational anesthesia techniques on tissue oxygenation in cardiac surgery. The primary objective of this study was to compare the effects of midazolam-based TIVA and sevoflurane-based (SEVO) inhalation anesthesia maintenance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Anesthesia
- What is being tested?
- TIVA and SEVO
- Type of treatment
- Surgery or procedure
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 1 Mar 2021
- 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: adult patients who undergoing coronary surgeries with cardiopulmonary bypass
Who may be able to join
- coronary surgeries with CPB
Who cannot join
- emergency surgeries,
- operations
- ejection fraction under 40%
- coronary surgeries in conjunction with other procedures
- cerebrovascular accident
- neurological disorders
- hematologic disorder
- chronic alcohol use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara City Hospital
Ankara, Select State/Province, 06800
About this study
Official title: The Effects of Total Intravenous and Inhalation Anesthesia Maintenance on Tissue Oxygenation in Coronary Artery Bypass Graft Surgery
The aim of this study was to evaluate the effect of total intravenous anesthesia (TIVA) and inhalational anesthesia techniques on tissue oxygenation in cardiac surgery. The primary objective of this study was to compare the effects of midazolam-based TIVA and sevoflurane-based (SEVO) inhalation anesthesia maintenance on intraoperative central and regional tissue oxygenation parameters.
Read the detailed description
A pressing issue in anesthesiology involves developing an understanding of the non-anesthetic effects of the medications typically used in intravenous and inhalation anesthesia methods. Few studies describe the effects of both intravenous and inhalational anesthetics on regional tissue perfusion is described under stable anesthetic conditions. There is the issue of whether inhalational anesthetics compromise regional tissue perfusion even though systemic parameters are within normal ranges. It is still debated how these effects may be different under pathophysiological conditions, such as cardiac surgery.
Maintaining tissue perfusion and oxygenation is the cornerstone of therapy for patients with cardiac disease. An imbalance in oxygen delivery and tissue oxygen consumption leads to anaerobic metabolism, cellular injury, and organ dysfunction, and is associated with poor outcomes. Consequently, monitoring tissue oxygen delivery and consumption status is of paramount importance in cardiac surgery patients. Routinely used monitors in intraoperative settings such as pulse oximetry, blood pressures, hemoglobin saturation levels, lactate, acid-base status, and central venous oxygen saturation levels all reflect tissue metabolism. Near-infrared spectroscopy (NIRS) is a non-invasive optical technique that can be used to continuously monitor tissue oxygen delivery and oxygen consumption status. Cerebral autoregulation can blunt the effect of impaired systemic oxygen delivery. Thus, cerebral NIRS may be a good predictor of neurological outcomes, but skeletal muscle NIRS serves as a follow-up indicator of many other postoperative complications due to impaired perfusion and oxygenation. Therefore, both cerebral and somatic monitoring may contribute to a more complete evaluation of hemodynamic competence. Obtaining the cerebral and somatic oxygenation levels are valuable to help in clinical management during cardiopulmonary bypass (CPB) and cardiac surgery as a whole.
The aim of this study was to evaluate the effect of total intravenous anesthesia (TIVA) and inhalational anesthesia techniques on tissue oxygenation in cardiac surgery. For this purpose, the effects of midazolam-based TIVA or sevoflurane-based inhalation anesthesia maintenance on intraoperative central and somatic tissue oxygenation parameters were compared in patients undergoing cardiac surgery.
- Conditions
- Cardiac Anesthesia
- Being tested
- TIVA, SEVO
- Keywords
- tissue oxygenation, total intravenous anesthesia, inhalational anesthesia, cardiac surgery, NIRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIVAProcedure or surgery
During the anesthesia maintenance of the TIVA group, 3 μg.kg-1 fentanyl, 0.01-0.05 mg.kg-1 midazolam, and 0.2 mg.kg-1 rocuronium bromide were applied throughout the operation to keep BIS between 40 and 60, approximately once every 45 minutes.
SEVOProcedure or surgery
During the anesthesia maintenance of the SEVO group, 2-3% sevoflurane (1-2 MAC), 3 μg.kg-1 fentanyl and 0.2 mg.kg-1 rocuronium bromide were applied throughout the operation to keep BIS between 40-60.
| Study group | Role | What they receive |
|---|---|---|
| TIVA group | During the anesthesia maintenance of the TIVA group, 3 μg.kg-1 fentanyl, 0.01-0.05 mg.kg-1 midazolam, and 0.2 mg.kg-1 rocuronium bromide were applied throughout the operation to keep BIS between 40 and 60, approximately once every 45 minutes. Receives: Procedure: TIVA | |
| SEVO group | During the anesthesia maintenance of the SEVO group, 2-3% sevoflurane (1-2 MAC), 3 μg.kg-1 fentanyl and 0.2 mg.kg-1 rocuronium bromide were applied throughout the operation to keep BIS between 40-60. Receives: Procedure: SEVO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic parameters
mean arterial pressure in mmHg was recorded
Measured: 5 minutes after anesthesia induction
Hemodynamic parameters
heart rate (beat per minute) were recorded
Measured: 5 minutes after anesthesia induction
Hemodynamic parameters
mean arterial pressure (mmHg) was recorded
Measured: After cardiopulmonary bypass cannulation, an average of 5 minutes
Hemodynamic parameters
heart rate (beat per minute) was recorded
Measured: After cardiopulmonary bypass cannulation, an average of 5 minutes
Hemodynamic parameters
mean arterial pressure (mmHg) was recorded
Measured: 10th minute of cardiopulmonary bypass
Hemodynamic parameters
heart rate (beat per minute) was recorded
Measured: 10th minute of cardiopulmonary bypass
Hemodynamic parameters
mean arterial pressure (mmHg) was recorded
Measured: 10 minutes after cross clamp removal
Hemodynamic parameters
heart rate (beat per minute) was recorded
Measured: 10 minutes after cross clamp removal
Hemodynamic parameters
mean arterial pressure (mmHg) was recorded
Measured: 10 minutes after CPB completion
Hemodynamic parameters
heart rate (beat per minute ) was recorded
Measured: 10 minutes after CPB completion
Hemodynamic parameters
mean arterial pressure (mmHg) was recorded
Measured: upon sternum closing
Hemodynamic parameters
heart rate (beat per minute) was recorded
Measured: upon sternum closing
Arterial gas sampling
pH levels were recorded
Measured: 5 minutes after anesthesia induction
Arterial gas sampling
central venous saturation (%) levels were recorded
Measured: 5 minutes after anesthesia induction
Arterial gas sampling
lactate levels (mmol/L) were recorded
Measured: 5 minutes after anesthesia induction
Arterial gas sampling
Hemoglobin (g/dL) levels were recorded
Measured: 5 minutes after anesthesia induction
Arterial gas sampling
pH levels were recorded
Measured: After cardiopulmonary bypass cannulation, an average of 5 minutes
Arterial gas sampling
central venous saturation (%) levels were recorded
Measured: After cardiopulmonary bypass cannulation, an average of 5 minutes
Arterial gas sampling
lactate (mmol/L) levels were recorded
Measured: After cardiopulmonary bypass cannulation, an average of 5 minutes
Arterial gas sampling
hemoglobin (g/dL)levels were recorded
Measured: After cardiopulmonary bypass cannulation, an average of 5 minutes
Arterial gas sampling
pH levels were recorded
Measured: 10th minute of cardiopulmonary bypass
Arterial gas sampling
central venous saturation (%) levels were recorded
Measured: 10th minute of cardiopulmonary bypass
Arterial gas sampling
lactate (mmol/L) levels were recorded
Measured: 10th minute of cardiopulmonary bypass
Arterial gas sampling
hemoglobin (g/dL) levels were recorded
Measured: 10th minute of cardiopulmonary bypass
Arterial gas sampling
pH levels were recorded
Measured: 10 minutes after cross clamp removal
Arterial gas sampling
central venous saturation (%) levels were recorded
Measured: 10 minutes after cross clamp removal
Arterial gas sampling
lactate (mmol/L) levels were recorded
Measured: 10 minutes after cross clamp removal
Arterial gas sampling
hemoglobin (g/dL) levels were recorded
Measured: 10 minutes after cross clamp removal
Arterial gas sampling
pH levels were recorded
Measured: 10 minutes after CPB completion
Arterial gas sampling
central venous saturation (%) levels were recorded
Measured: 10 minutes after CPB completion
Arterial gas sampling
lactate (mmol/L) levels were recorded
Measured: 10 minutes after CPB completion
Arterial gas sampling
hemoglobin (g/dL) levels were recorded
Measured: 10 minutes after CPB completion
Arterial gas sampling
pH levels were recorded
Measured: upon sternum closing
Arterial gas sampling
central venous saturation (%) levels were recorded
Measured: upon sternum closing
Arterial gas sampling
lactate (mmol/L) levels were recorded
Measured: upon sternum closing
Arterial gas sampling
hemoglobin (g/dL) levels were recorded
Measured: upon sternum closing
NIRS
cerebral (rSO2) values were recorded
Measured: 5 minutes after anesthesia induction
NIRS
somatic (rSO2) values were recorded
Measured: 5 minutes after anesthesia induction
NIRS
cerebral (rSO2) values were recorded
Measured: After cardiopulmonary bypass cannulation, an average of 5 minutes
NIRS
somatic(rSO2) values were recorded
Measured: After cardiopulmonary bypass cannulation, an average of 5 minutes
NIRS
cerebral (rSO2) values were recorded
Measured: 10th minute of cardiopulmonary bypass
NIRS
somatic (rSO2) values were recorded
Measured: 10th minute of cardiopulmonary bypass
NIRS
cerebral (rSO2) were recorded
Measured: 10 minutes after cross clamp removal
NIRS
somatic (rSO2) were recorded
Measured: 10 minutes after cross clamp removal
NIRS
cerebral(rSO2)values were recorded
Measured: 10 minutes after CPB completion
NIRS
somatic (rSO2) values were recorded
Measured: 10 minutes after CPB completion
NIRS
cerebral(rSO2)values were recorded
Measured: upon sternum closing
NIRS
somatic (rSO2) values were recorded
Measured: upon sternum closing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 Feb 2019
- Primary completion1 Nov 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac AnesthesiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Balci, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320341
- Sponsor's protocol ID
- MH.2.5
- Status last verified
- Apr 2022
- First submitted
- 23 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Turek Z, Sykora R, Matejovic M, Cerny V. Anesthesia and the microcirculation. Semin Cardiothorac Vasc Anesth. 2009 Dec;13(4):249-58. doi: 10.1177/1089253209353134. Epub 2009 Dec 2.
PubMed 19959497Bickler P, Feiner J, Rollins M, Meng L. Tissue Oximetry and Clinical Outcomes. Anesth Analg. 2017 Jan;124(1):72-82. doi: 10.1213/ANE.0000000000001348.
PubMed 27308951De Backer D, Dubois MJ, Schmartz D, Koch M, Ducart A, Barvais L, Vincent JL. Microcirculatory alterations in cardiac surgery: effects of cardiopulmonary bypass and anesthesia. Ann Thorac Surg. 2009 Nov;88(5):1396-403. doi: 10.1016/j.athoracsur.2009.07.002.
PubMed 19853081
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Total Intravenous and Inhalation Anesthesia Maintenance on Tissue Oxygenation in Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT05320341
- Acronym / sponsor ID
- MH.2.5
- Conditions
- Cardiac Anesthesia
- Keywords
- tissue oxygenation, total intravenous anesthesia, inhalational anesthesia, cardiac surgery, NIRS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 11 Apr 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.
The aim of this study was to evaluate the effect of total intravenous anesthesia (TIVA) and inhalational anesthesia techniques on tissue oxygenation in cardiac surgery. The primary objective of this study was to compare the effects of midazolam-based TIVA and sevoflurane-based (SEVO) inhalation anesthesia maintenance on intraoperative central and regional tissue oxygenation parameters.
Detailed description
A pressing issue in anesthesiology involves developing an understanding of the non-anesthetic effects of the medications typically used in intravenous and inhalation anesthesia methods. Few studies describe the effects of both intravenous and inhalational anesthetics on regional tissue perfusion is described under stable anesthetic conditions. There is the issue of whether inhalational anesthetics compromise regional tissue perfusion even though systemic parameters are within normal ranges. It is still debated how these effects may be different under pathophysiological conditions, such as cardiac surgery.
Maintaining tissue perfusion and oxygenation is the cornerstone of therapy for patients with cardiac disease. An imbalance in oxygen delivery and tissue oxygen consumption leads to anaerobic metabolism, cellular injury, and organ dysfunction, and is associated with poor outcomes. Consequently, monitoring tissue oxygen delivery and consumption status is of paramount importance in cardiac surgery patients. Routinely used monitors in intraoperative settings such as pulse oximetry, blood pressures, hemoglobin saturation levels, lactate, acid-base status, and central venous oxygen saturation levels all reflect tissue metabolism. Near-infrared spectroscopy (NIRS) is a non-invasive optical technique that can be used to continuously monitor tissue oxygen delivery and oxygen consumption status. Cerebral autoregulation can blunt the effect of impaired systemic oxygen delivery. Thus, cerebral NIRS may be a good predictor of neurological outcomes, but skeletal muscle NIRS serves as a follow-up indicator of many other postoperative complications due to impaired perfusion and oxygenation. Therefore, both cerebral and somatic monitoring may contribute to a more complete evaluation of hemodynamic competence. Obtaining the cerebral and somatic oxygenation levels are valuable to help in clinical management during cardiopulmonary bypass (CPB) and cardiac surgery as a whole.
The aim of this study was to evaluate the effect of total intravenous anesthesia (TIVA) and inhalational anesthesia techniques on tissue oxygenation in cardiac surgery. For this purpose, the effects of midazolam-based TIVA or sevoflurane-based inhalation anesthesia maintenance on intraoperative central and somatic tissue oxygenation parameters were compared in patients undergoing cardiac surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIVA group | – | Procedure: TIVADuring the anesthesia maintenance of the TIVA group, 3 μg.kg-1 fentanyl, 0.01-0.05 mg.kg-1 midazolam, and 0.2 mg.kg-1 rocuronium bromide were applied throughout the operation to keep BIS between 40 and 60, approximately once every 45 minutes. |
| SEVO group | – | Procedure: SEVODuring the anesthesia maintenance of the SEVO group, 2-3% sevoflurane (1-2 MAC), 3 μg.kg-1 fentanyl and 0.2 mg.kg-1 rocuronium bromide were applied throughout the operation to keep BIS between 40-60. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients who undergoing coronary surgeries with cardiopulmonary bypass
Key inclusion criteria (1 listed)
- coronary surgeries with CPB
Key exclusion criteria (8 listed)
- emergency surgeries,
- operations
- ejection fraction under 40%
- coronary surgeries in conjunction with other procedures
- cerebrovascular accident
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 |
|---|---|---|
| TIVADuring the anesthesia maintenance of the TIVA group, 3 μg.kg-1 fentanyl, 0.01-0.05 mg.kg-1 midazolam, and 0.2 mg.kg-1 rocuronium bromide were applied throughout the operation to keep BIS between 40 and 60, approximately once every 45 minutes. | Procedure or surgery | TIVA group |
| SEVODuring the anesthesia maintenance of the SEVO group, 2-3% sevoflurane (1-2 MAC), 3 μg.kg-1 fentanyl and 0.2 mg.kg-1 rocuronium bromide were applied throughout the operation to keep BIS between 40-60. | Procedure or surgery | SEVO group |
Primary outcome
Hemodynamic parameters
Time frame: 5 minutes after anesthesia induction
mean arterial pressure in mmHg was recorded
Hemodynamic parameters
Time frame: 5 minutes after anesthesia induction
heart rate (beat per minute) were recorded
Hemodynamic parameters
Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes
mean arterial pressure (mmHg) was recorded
Hemodynamic parameters
Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes
heart rate (beat per minute) was recorded
Hemodynamic parameters
Time frame: 10th minute of cardiopulmonary bypass
mean arterial pressure (mmHg) was recorded
Hemodynamic parameters
Time frame: 10th minute of cardiopulmonary bypass
heart rate (beat per minute) was recorded
Hemodynamic parameters
Time frame: 10 minutes after cross clamp removal
mean arterial pressure (mmHg) was recorded
Hemodynamic parameters
Time frame: 10 minutes after cross clamp removal
heart rate (beat per minute) was recorded
Hemodynamic parameters
Time frame: 10 minutes after CPB completion
mean arterial pressure (mmHg) was recorded
Hemodynamic parameters
Time frame: 10 minutes after CPB completion
heart rate (beat per minute ) was recorded
Hemodynamic parameters
Time frame: upon sternum closing
mean arterial pressure (mmHg) was recorded
Hemodynamic parameters
Time frame: upon sternum closing
heart rate (beat per minute) was recorded
Arterial gas sampling
Time frame: 5 minutes after anesthesia induction
pH levels were recorded
Arterial gas sampling
Time frame: 5 minutes after anesthesia induction
central venous saturation (%) levels were recorded
Arterial gas sampling
Time frame: 5 minutes after anesthesia induction
lactate levels (mmol/L) were recorded
Arterial gas sampling
Time frame: 5 minutes after anesthesia induction
Hemoglobin (g/dL) levels were recorded
Arterial gas sampling
Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes
pH levels were recorded
Arterial gas sampling
Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes
central venous saturation (%) levels were recorded
Arterial gas sampling
Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes
lactate (mmol/L) levels were recorded
Arterial gas sampling
Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes
hemoglobin (g/dL)levels were recorded
Arterial gas sampling
Time frame: 10th minute of cardiopulmonary bypass
pH levels were recorded
Arterial gas sampling
Time frame: 10th minute of cardiopulmonary bypass
central venous saturation (%) levels were recorded
Arterial gas sampling
Time frame: 10th minute of cardiopulmonary bypass
lactate (mmol/L) levels were recorded
Arterial gas sampling
Time frame: 10th minute of cardiopulmonary bypass
hemoglobin (g/dL) levels were recorded
Arterial gas sampling
Time frame: 10 minutes after cross clamp removal
pH levels were recorded
Arterial gas sampling
Time frame: 10 minutes after cross clamp removal
central venous saturation (%) levels were recorded
Arterial gas sampling
Time frame: 10 minutes after cross clamp removal
lactate (mmol/L) levels were recorded
Arterial gas sampling
Time frame: 10 minutes after cross clamp removal
hemoglobin (g/dL) levels were recorded
Arterial gas sampling
Time frame: 10 minutes after CPB completion
pH levels were recorded
Arterial gas sampling
Time frame: 10 minutes after CPB completion
central venous saturation (%) levels were recorded
Arterial gas sampling
Time frame: 10 minutes after CPB completion
lactate (mmol/L) levels were recorded
Arterial gas sampling
Time frame: 10 minutes after CPB completion
hemoglobin (g/dL) levels were recorded
Arterial gas sampling
Time frame: upon sternum closing
pH levels were recorded
Arterial gas sampling
Time frame: upon sternum closing
central venous saturation (%) levels were recorded
Arterial gas sampling
Time frame: upon sternum closing
lactate (mmol/L) levels were recorded
Arterial gas sampling
Time frame: upon sternum closing
hemoglobin (g/dL) levels were recorded
NIRS
Time frame: 5 minutes after anesthesia induction
cerebral (rSO2) values were recorded
NIRS
Time frame: 5 minutes after anesthesia induction
somatic (rSO2) values were recorded
NIRS
Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes
cerebral (rSO2) values were recorded
NIRS
Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes
somatic(rSO2) values were recorded
NIRS
Time frame: 10th minute of cardiopulmonary bypass
cerebral (rSO2) values were recorded
NIRS
Time frame: 10th minute of cardiopulmonary bypass
somatic (rSO2) values were recorded
NIRS
Time frame: 10 minutes after cross clamp removal
cerebral (rSO2) were recorded
NIRS
Time frame: 10 minutes after cross clamp removal
somatic (rSO2) were recorded
NIRS
Time frame: 10 minutes after CPB completion
cerebral(rSO2)values were recorded
NIRS
Time frame: 10 minutes after CPB completion
somatic (rSO2) values were recorded
NIRS
Time frame: upon sternum closing
cerebral(rSO2)values were recorded
NIRS
Time frame: upon sternum closing
somatic (rSO2) values were recorded
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 11 Apr 2022.
- Results publication: PubMed 19959497Turek Z, Sykora R, Matejovic M, Cerny V. Anesthesia and the microcirculation. Semin Cardiothorac Vasc Anesth. 2009 Dec;13(4):249-58. doi: 10.1177/1089253209353134. Epub 2009 Dec 2.
- Results publication: PubMed 27308951Bickler P, Feiner J, Rollins M, Meng L. Tissue Oximetry and Clinical Outcomes. Anesth Analg. 2017 Jan;124(1):72-82. doi: 10.1213/ANE.0000000000001348.
- Results publication: PubMed 19853081De Backer D, Dubois MJ, Schmartz D, Koch M, Ducart A, Barvais L, Vincent JL. Microcirculatory alterations in cardiac surgery: effects of cardiopulmonary bypass and anesthesia. Ann Thorac Surg. 2009 Nov;88(5):1396-403. doi: 10.1016/j.athoracsur.2009.07.002.
- Individual participant dataSharing planned: Undecided
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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 Cardiac Anesthesia, 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 1 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: finished, as of the sponsor's last update on 11 Apr 2022. 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?
Hemodynamic parameters (time frame: 5 minutes after anesthesia induction). The study lists 48 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05320341, which also lists 3 linked publications.
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 11 Apr 2022.