Clinical trial NCT05320341: TIVA Versus Inhalational Anesthesia and Tissue Oxygenation in Cardiac Surgery
Official title: The Effects of Total Intravenous and Inhalation Anesthesia Maintenance on Tissue Oxygenation in Coronary Artery Bypass Graft Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Anesthesia
Keywords: tissue oxygenation
total intravenous anesthesia
inhalational anesthesia
cardiac surgery
NIRS
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients who undergoing coronary surgeries with cardiopulmonary bypass

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

- coronary surgeries with CPB

Exclusion Criteria:

* emergency surgeries,
* operations
* ejection fraction under 40%
* coronary surgeries in conjunction with other procedures
* cerebrovascular accident
* neurological disorders
* hematologic disorder
* chronic alcohol use

Primary outcomes:
measure: Hemodynamic parameters
timeFrame: 5 minutes after anesthesia induction
measure: Hemodynamic parameters
timeFrame: 5 minutes after anesthesia induction
measure: Hemodynamic parameters
timeFrame: After cardiopulmonary bypass cannulation, an average of 5 minutes
measure: Hemodynamic parameters
timeFrame: After cardiopulmonary bypass cannulation, an average of 5 minutes
measure: Hemodynamic parameters
timeFrame: 10th minute of cardiopulmonary bypass
measure: Hemodynamic parameters
timeFrame: 10th minute of cardiopulmonary bypass
measure: Hemodynamic parameters
timeFrame: 10 minutes after cross clamp removal
measure: Hemodynamic parameters
timeFrame: 10 minutes after cross clamp removal
measure: Hemodynamic parameters
timeFrame: 10 minutes after CPB completion
measure: Hemodynamic parameters
timeFrame: 10 minutes after CPB completion
measure: Hemodynamic parameters
timeFrame: upon sternum closing
measure: Hemodynamic parameters
timeFrame: upon sternum closing
measure: Arterial gas sampling
timeFrame: 5 minutes after anesthesia induction
measure: Arterial gas sampling
timeFrame: 5 minutes after anesthesia induction
measure: Arterial gas sampling
timeFrame: 5 minutes after anesthesia induction
measure: Arterial gas sampling
timeFrame: 5 minutes after anesthesia induction
measure: Arterial gas sampling
timeFrame: After cardiopulmonary bypass cannulation, an average of 5 minutes
measure: Arterial gas sampling
timeFrame: After cardiopulmonary bypass cannulation, an average of 5 minutes
measure: Arterial gas sampling
timeFrame: After cardiopulmonary bypass cannulation, an average of 5 minutes
measure: Arterial gas sampling
timeFrame: After cardiopulmonary bypass cannulation, an average of 5 minutes
measure: Arterial gas sampling
timeFrame: 10th minute of cardiopulmonary bypass
measure: Arterial gas sampling
timeFrame: 10th minute of cardiopulmonary bypass
measure: Arterial gas sampling
timeFrame: 10th minute of cardiopulmonary bypass
measure: Arterial gas sampling
timeFrame: 10th minute of cardiopulmonary bypass
measure: Arterial gas sampling
timeFrame: 10 minutes after cross clamp removal
measure: Arterial gas sampling
timeFrame: 10 minutes after cross clamp removal
measure: Arterial gas sampling
timeFrame: 10 minutes after cross clamp removal
measure: Arterial gas sampling
timeFrame: 10 minutes after cross clamp removal
measure: Arterial gas sampling
timeFrame: 10 minutes after CPB completion
measure: Arterial gas sampling
timeFrame: 10 minutes after CPB completion
measure: Arterial gas sampling
timeFrame: 10 minutes after CPB completion
measure: Arterial gas sampling
timeFrame: 10 minutes after CPB completion
measure: Arterial gas sampling
timeFrame: upon sternum closing
measure: Arterial gas sampling
timeFrame: upon sternum closing
measure: Arterial gas sampling
timeFrame: upon sternum closing
measure: Arterial gas sampling
timeFrame: upon sternum closing
measure: NIRS
timeFrame: 5 minutes after anesthesia induction
measure: NIRS
timeFrame: 5 minutes after anesthesia induction
measure: NIRS
timeFrame: After cardiopulmonary bypass cannulation, an average of 5 minutes
measure: NIRS
timeFrame: After cardiopulmonary bypass cannulation, an average of 5 minutes
measure: NIRS
timeFrame: 10th minute of cardiopulmonary bypass
measure: NIRS
timeFrame: 10th minute of cardiopulmonary bypass
measure: NIRS
timeFrame: 10 minutes after cross clamp removal
measure: NIRS
timeFrame: 10 minutes after cross clamp removal
measure: NIRS
timeFrame: 10 minutes after CPB completion
measure: NIRS
timeFrame: 10 minutes after CPB completion
measure: NIRS
timeFrame: upon sternum closing
measure: NIRS
timeFrame: upon sternum closing
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
state: Select State/Province
Study officials:
References:
citation: 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.
citation: Bickler 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.
citation: De 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.