An observational study in Cardiac Anesthesia, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-11.
Sponsored by Ankara City Hospital Bilkent · Observational
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.
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.
Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.
Counted across the registry records on this site, refreshed daily.
adult patients who undergoing coronary surgeries with cardiopulmonary bypass
Exclusion Criteria:
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.
Procedure: TIVA
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.
Procedure: SEVO
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.
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.
Hemodynamic parameters
mean arterial pressure in mmHg was recorded
Time frame: 5 minutes after anesthesia induction
Hemodynamic parameters
heart rate (beat per minute) were recorded
Time frame: 5 minutes after anesthesia induction
Hemodynamic parameters
mean arterial pressure (mmHg) was recorded
Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes
Hemodynamic parameters
heart rate (beat per minute) was recorded
Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes
Hemodynamic parameters
mean arterial pressure (mmHg) was recorded
Time frame: 10th minute of cardiopulmonary bypass
Hemodynamic parameters
heart rate (beat per minute) was recorded
Time frame: 10th minute of cardiopulmonary bypass
Hemodynamic parameters
mean arterial pressure (mmHg) was recorded
Time frame: 10 minutes after cross clamp removal
Hemodynamic parameters
heart rate (beat per minute) was recorded
Time frame: 10 minutes after cross clamp removal
Hemodynamic parameters
mean arterial pressure (mmHg) was recorded
Time frame: 10 minutes after CPB completion
Hemodynamic parameters
heart rate (beat per minute ) was recorded
Time frame: 10 minutes after CPB completion
Hemodynamic parameters
mean arterial pressure (mmHg) was recorded
Time frame: upon sternum closing
Hemodynamic parameters
heart rate (beat per minute) was recorded
Time frame: upon sternum closing
Arterial gas sampling
pH levels were recorded
Time frame: 5 minutes after anesthesia induction
Arterial gas sampling
central venous saturation (%) levels were recorded
Time frame: 5 minutes after anesthesia induction
Arterial gas sampling
lactate levels (mmol/L) were recorded
Time frame: 5 minutes after anesthesia induction
Arterial gas sampling
Hemoglobin (g/dL) levels were recorded
Time frame: 5 minutes after anesthesia induction
Arterial gas sampling
pH levels were recorded
Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes
Arterial gas sampling
central venous saturation (%) levels were recorded
Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes
Arterial gas sampling
lactate (mmol/L) levels were recorded
Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes
Arterial gas sampling
hemoglobin (g/dL)levels were recorded
Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes
Arterial gas sampling
pH levels were recorded
Time frame: 10th minute of cardiopulmonary bypass
Arterial gas sampling
central venous saturation (%) levels were recorded
Time frame: 10th minute of cardiopulmonary bypass
Arterial gas sampling
lactate (mmol/L) levels were recorded
Time frame: 10th minute of cardiopulmonary bypass
Arterial gas sampling
hemoglobin (g/dL) levels were recorded
Time frame: 10th minute of cardiopulmonary bypass
Arterial gas sampling
pH levels were recorded
Time frame: 10 minutes after cross clamp removal
Arterial gas sampling
central venous saturation (%) levels were recorded
Time frame: 10 minutes after cross clamp removal
Arterial gas sampling
lactate (mmol/L) levels were recorded
Time frame: 10 minutes after cross clamp removal
Arterial gas sampling
hemoglobin (g/dL) levels were recorded
Time frame: 10 minutes after cross clamp removal
Arterial gas sampling
pH levels were recorded
Time frame: 10 minutes after CPB completion
Arterial gas sampling
central venous saturation (%) levels were recorded
Time frame: 10 minutes after CPB completion
Arterial gas sampling
lactate (mmol/L) levels were recorded
Time frame: 10 minutes after CPB completion
Arterial gas sampling
hemoglobin (g/dL) levels were recorded
Time frame: 10 minutes after CPB completion
Arterial gas sampling
pH levels were recorded
Time frame: upon sternum closing
Arterial gas sampling
central venous saturation (%) levels were recorded
Time frame: upon sternum closing
Arterial gas sampling
lactate (mmol/L) levels were recorded
Time frame: upon sternum closing
Arterial gas sampling
hemoglobin (g/dL) levels were recorded
Time frame: upon sternum closing
NIRS
cerebral (rSO2) values were recorded
Time frame: 5 minutes after anesthesia induction
NIRS
somatic (rSO2) values were recorded
Time frame: 5 minutes after anesthesia induction
NIRS
cerebral (rSO2) values were recorded
Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes
NIRS
somatic(rSO2) values were recorded
Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes
NIRS
cerebral (rSO2) values were recorded
Time frame: 10th minute of cardiopulmonary bypass
NIRS
somatic (rSO2) values were recorded
Time frame: 10th minute of cardiopulmonary bypass
NIRS
cerebral (rSO2) were recorded
Time frame: 10 minutes after cross clamp removal
NIRS
somatic (rSO2) were recorded
Time frame: 10 minutes after cross clamp removal
NIRS
cerebral(rSO2)values were recorded
Time frame: 10 minutes after CPB completion
NIRS
somatic (rSO2) values were recorded
Time frame: 10 minutes after CPB completion
NIRS
cerebral(rSO2)values were recorded
Time frame: upon sternum closing
NIRS
somatic (rSO2) values were recorded
Time frame: upon sternum closing
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Ankara City Hospital Bilkent