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Completed

NCT Number: NCT05320341

TIVA Versus Inhalational Anesthesia and Tissue Oxygenation in Cardiac 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.

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Key information

Conditions

Cardiac Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara City Hospital

Ankara, Select State/Province, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TIVA

Procedure

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.

SEVO

Procedure

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.

Primary outcomes

  1. Hemodynamic parameters

    Time frame: 5 minutes after anesthesia induction

    mean arterial pressure in mmHg was recorded

  2. Hemodynamic parameters

    Time frame: 5 minutes after anesthesia induction

    heart rate (beat per minute) were recorded

  3. Hemodynamic parameters

    Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes

    mean arterial pressure (mmHg) was recorded

  4. Hemodynamic parameters

    Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes

    heart rate (beat per minute) was recorded

  5. Hemodynamic parameters

    Time frame: 10th minute of cardiopulmonary bypass

    mean arterial pressure (mmHg) was recorded

  6. Hemodynamic parameters

    Time frame: 10th minute of cardiopulmonary bypass

    heart rate (beat per minute) was recorded

  7. Hemodynamic parameters

    Time frame: 10 minutes after cross clamp removal

    mean arterial pressure (mmHg) was recorded

  8. Hemodynamic parameters

    Time frame: 10 minutes after cross clamp removal

    heart rate (beat per minute) was recorded

  9. Hemodynamic parameters

    Time frame: 10 minutes after CPB completion

    mean arterial pressure (mmHg) was recorded

  10. Hemodynamic parameters

    Time frame: 10 minutes after CPB completion

    heart rate (beat per minute ) was recorded

  11. Hemodynamic parameters

    Time frame: upon sternum closing

    mean arterial pressure (mmHg) was recorded

  12. Hemodynamic parameters

    Time frame: upon sternum closing

    heart rate (beat per minute) was recorded

  13. Arterial gas sampling

    Time frame: 5 minutes after anesthesia induction

    pH levels were recorded

  14. Arterial gas sampling

    Time frame: 5 minutes after anesthesia induction

    central venous saturation (%) levels were recorded

  15. Arterial gas sampling

    Time frame: 5 minutes after anesthesia induction

    lactate levels (mmol/L) were recorded

  16. Arterial gas sampling

    Time frame: 5 minutes after anesthesia induction

    Hemoglobin (g/dL) levels were recorded

  17. Arterial gas sampling

    Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes

    pH levels were recorded

  18. Arterial gas sampling

    Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes

    central venous saturation (%) levels were recorded

  19. Arterial gas sampling

    Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes

    lactate (mmol/L) levels were recorded

  20. Arterial gas sampling

    Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes

    hemoglobin (g/dL)levels were recorded

  21. Arterial gas sampling

    Time frame: 10th minute of cardiopulmonary bypass

    pH levels were recorded

  22. Arterial gas sampling

    Time frame: 10th minute of cardiopulmonary bypass

    central venous saturation (%) levels were recorded

  23. Arterial gas sampling

    Time frame: 10th minute of cardiopulmonary bypass

    lactate (mmol/L) levels were recorded

  24. Arterial gas sampling

    Time frame: 10th minute of cardiopulmonary bypass

    hemoglobin (g/dL) levels were recorded

  25. Arterial gas sampling

    Time frame: 10 minutes after cross clamp removal

    pH levels were recorded

  26. Arterial gas sampling

    Time frame: 10 minutes after cross clamp removal

    central venous saturation (%) levels were recorded

  27. Arterial gas sampling

    Time frame: 10 minutes after cross clamp removal

    lactate (mmol/L) levels were recorded

  28. Arterial gas sampling

    Time frame: 10 minutes after cross clamp removal

    hemoglobin (g/dL) levels were recorded

  29. Arterial gas sampling

    Time frame: 10 minutes after CPB completion

    pH levels were recorded

  30. Arterial gas sampling

    Time frame: 10 minutes after CPB completion

    central venous saturation (%) levels were recorded

  31. Arterial gas sampling

    Time frame: 10 minutes after CPB completion

    lactate (mmol/L) levels were recorded

  32. Arterial gas sampling

    Time frame: 10 minutes after CPB completion

    hemoglobin (g/dL) levels were recorded

  33. Arterial gas sampling

    Time frame: upon sternum closing

    pH levels were recorded

  34. Arterial gas sampling

    Time frame: upon sternum closing

    central venous saturation (%) levels were recorded

  35. Arterial gas sampling

    Time frame: upon sternum closing

    lactate (mmol/L) levels were recorded

  36. Arterial gas sampling

    Time frame: upon sternum closing

    hemoglobin (g/dL) levels were recorded

  37. NIRS

    Time frame: 5 minutes after anesthesia induction

    cerebral (rSO2) values were recorded

  38. NIRS

    Time frame: 5 minutes after anesthesia induction

    somatic (rSO2) values were recorded

  39. NIRS

    Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes

    cerebral (rSO2) values were recorded

  40. NIRS

    Time frame: After cardiopulmonary bypass cannulation, an average of 5 minutes

    somatic(rSO2) values were recorded

  41. NIRS

    Time frame: 10th minute of cardiopulmonary bypass

    cerebral (rSO2) values were recorded

  42. NIRS

    Time frame: 10th minute of cardiopulmonary bypass

    somatic (rSO2) values were recorded

  43. NIRS

    Time frame: 10 minutes after cross clamp removal

    cerebral (rSO2) were recorded

  44. NIRS

    Time frame: 10 minutes after cross clamp removal

    somatic (rSO2) were recorded

  45. NIRS

    Time frame: 10 minutes after CPB completion

    cerebral(rSO2)values were recorded

  46. NIRS

    Time frame: 10 minutes after CPB completion

    somatic (rSO2) values were recorded

  47. NIRS

    Time frame: upon sternum closing

    cerebral(rSO2)values were recorded

  48. NIRS

    Time frame: upon sternum closing

    somatic (rSO2) values were recorded

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

The Effects of Total Intravenous and Inhalation Anesthesia Maintenance on Tissue Oxygenation in Coronary Artery Bypass Graft Surgery

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 11, 2022
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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