NCT05320341

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

1.8 years

First QC Date

March 23, 2022

Last Update Submit

April 1, 2022

Conditions

Cardiac Anesthesia

Keywords

tissue oxygenationtotal intravenous anesthesiainhalational anesthesiacardiac surgeryNIRS

Outcome Measures

Primary Outcomes (48)

  • Hemodynamic parameters

    mean arterial pressure in mmHg was recorded

    5 minutes after anesthesia induction

  • Hemodynamic parameters

    heart rate (beat per minute) were recorded

    5 minutes after anesthesia induction

  • Hemodynamic parameters

    mean arterial pressure (mmHg) was recorded

    After cardiopulmonary bypass cannulation, an average of 5 minutes

  • Hemodynamic parameters

    heart rate (beat per minute) was recorded

    After cardiopulmonary bypass cannulation, an average of 5 minutes

  • Hemodynamic parameters

    mean arterial pressure (mmHg) was recorded

    10th minute of cardiopulmonary bypass

  • Hemodynamic parameters

    heart rate (beat per minute) was recorded

    10th minute of cardiopulmonary bypass

  • Hemodynamic parameters

    mean arterial pressure (mmHg) was recorded

    10 minutes after cross clamp removal

  • Hemodynamic parameters

    heart rate (beat per minute) was recorded

    10 minutes after cross clamp removal

  • Hemodynamic parameters

    mean arterial pressure (mmHg) was recorded

    10 minutes after CPB completion

  • Hemodynamic parameters

    heart rate (beat per minute ) was recorded

    10 minutes after CPB completion

  • Hemodynamic parameters

    mean arterial pressure (mmHg) was recorded

    upon sternum closing

  • Hemodynamic parameters

    heart rate (beat per minute) was recorded

    upon sternum closing

  • Arterial gas sampling

    pH levels were recorded

    5 minutes after anesthesia induction

  • Arterial gas sampling

    central venous saturation (%) levels were recorded

    5 minutes after anesthesia induction

  • Arterial gas sampling

    lactate levels (mmol/L) were recorded

    5 minutes after anesthesia induction

  • Arterial gas sampling

    Hemoglobin (g/dL) levels were recorded

    5 minutes after anesthesia induction

  • Arterial gas sampling

    pH levels were recorded

    After cardiopulmonary bypass cannulation, an average of 5 minutes

  • Arterial gas sampling

    central venous saturation (%) levels were recorded

    After cardiopulmonary bypass cannulation, an average of 5 minutes

  • Arterial gas sampling

    lactate (mmol/L) levels were recorded

    After cardiopulmonary bypass cannulation, an average of 5 minutes

  • Arterial gas sampling

    hemoglobin (g/dL)levels were recorded

    After cardiopulmonary bypass cannulation, an average of 5 minutes

  • Arterial gas sampling

    pH levels were recorded

    10th minute of cardiopulmonary bypass

  • Arterial gas sampling

    central venous saturation (%) levels were recorded

    10th minute of cardiopulmonary bypass

  • Arterial gas sampling

    lactate (mmol/L) levels were recorded

    10th minute of cardiopulmonary bypass

  • Arterial gas sampling

    hemoglobin (g/dL) levels were recorded

    10th minute of cardiopulmonary bypass

  • Arterial gas sampling

    pH levels were recorded

    10 minutes after cross clamp removal

  • Arterial gas sampling

    central venous saturation (%) levels were recorded

    10 minutes after cross clamp removal

  • Arterial gas sampling

    lactate (mmol/L) levels were recorded

    10 minutes after cross clamp removal

  • Arterial gas sampling

    hemoglobin (g/dL) levels were recorded

    10 minutes after cross clamp removal

  • Arterial gas sampling

    pH levels were recorded

    10 minutes after CPB completion

  • Arterial gas sampling

    central venous saturation (%) levels were recorded

    10 minutes after CPB completion

  • Arterial gas sampling

    lactate (mmol/L) levels were recorded

    10 minutes after CPB completion

  • Arterial gas sampling

    hemoglobin (g/dL) levels were recorded

    10 minutes after CPB completion

  • Arterial gas sampling

    pH levels were recorded

    upon sternum closing

  • Arterial gas sampling

    central venous saturation (%) levels were recorded

    upon sternum closing

  • Arterial gas sampling

    lactate (mmol/L) levels were recorded

    upon sternum closing

  • Arterial gas sampling

    hemoglobin (g/dL) levels were recorded

    upon sternum closing

  • NIRS

    cerebral (rSO2) values were recorded

    5 minutes after anesthesia induction

  • NIRS

    somatic (rSO2) values were recorded

    5 minutes after anesthesia induction

  • NIRS

    cerebral (rSO2) values were recorded

    After cardiopulmonary bypass cannulation, an average of 5 minutes

  • NIRS

    somatic(rSO2) values were recorded

    After cardiopulmonary bypass cannulation, an average of 5 minutes

  • NIRS

    cerebral (rSO2) values were recorded

    10th minute of cardiopulmonary bypass

  • NIRS

    somatic (rSO2) values were recorded

    10th minute of cardiopulmonary bypass

  • NIRS

    cerebral (rSO2) were recorded

    10 minutes after cross clamp removal

  • NIRS

    somatic (rSO2) were recorded

    10 minutes after cross clamp removal

  • NIRS

    cerebral(rSO2)values were recorded

    10 minutes after CPB completion

  • NIRS

    somatic (rSO2) values were recorded

    10 minutes after CPB completion

  • NIRS

    cerebral(rSO2)values were recorded

    upon sternum closing

  • NIRS

    somatic (rSO2) values were recorded

    upon sternum closing

Study Arms (2)

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.

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.

Procedure: SEVO

Interventions

TIVAPROCEDURE

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.

TIVA group
SEVOPROCEDURE

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.

SEVO group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients who undergoing coronary surgeries with cardiopulmonary bypass

You may qualify if:

  • \- coronary surgeries with CPB

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

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

Location

Related Publications (3)

  • 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.

    PMID: 19959497RESULT

  • 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.

    PMID: 27308951RESULT

  • 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.

    PMID: 19853081RESULT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

March 23, 2022

First Posted

April 11, 2022

Study Start

February 1, 2019

Primary Completion

November 1, 2020

Study Completion

March 1, 2021

Last Updated

April 11, 2022

Record last verified: 2022-04

Locations

TU(1)