Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484575
Status:
COMPLETED
Last Update Posted:
2010-05-20
First Post:
2007-06-08
Brief Title:
Inhaled Sevoflurane Compared to Intravenous Sedation Post Coronary Artery Bypass Grafting
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Inhaled Sevoflurane Compared to Intravenous Sedation Post Coronary Artery Bypass Grafting
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Inhaled sevoflurane during coronary artery bypass grafting CABG reduces postoperative Troponin levels and may be associated with improved outcome A dose-response effect has been demonstrated by de Hert et al with greatest reductions of Troponin when Sevoflurane was used during the entire operation as compared to Sevoflurane during parts of the operation
Sevoflurane as other inhaled anesthetic agents is sedative in low doses Postoperative sedation after CABG is currently achieved with intravenous propofol
A new simplified method of administration of isoflurane or sevoflurane has been developed and tested by members of the research group The Anesthetic Conserving Device is a modified heat-moisture exchanger HME that permits direct infusion of sevoflurane to the airway where it is vaporized in an evaporator rod in the device
The primary aim and primary hypothesisof the current trial is to examine if postoperative sedation with sevoflurane after CABG is associated with improved cardiac outcome measured as reduced levels of Troponin BNP and reduced incidence of cardiac events such as atrial fibrillation need for inotropic drugs and myocardial infarction compared with conventional propofol sedation
Other end-points of the trial are potential renal protective effects measured with cystatin C levels need for dialysis but also measurements of inorganic fluorides in serum as well as environmental aspects of sevoflurane sedation in a Cardiothoracic Intensive Care Unit Furthermore potential differences in ICU memories and well-being during stay in the intensive Care Unit will be investigated via patient questionnaires
Besides routine blood sampling plasma will be saved for later analysis of inflammatory mediators biobank
Sevoflurane as other inhaled anesthetic agents is sedative in low doses Postoperative sedation after CABG is currently achieved with intravenous propofol
A new simplified method of administration of isoflurane or sevoflurane has been developed and tested by members of the research group The Anesthetic Conserving Device is a modified heat-moisture exchanger HME that permits direct infusion of sevoflurane to the airway where it is vaporized in an evaporator rod in the device
The primary aim and primary hypothesisof the current trial is to examine if postoperative sedation with sevoflurane after CABG is associated with improved cardiac outcome measured as reduced levels of Troponin BNP and reduced incidence of cardiac events such as atrial fibrillation need for inotropic drugs and myocardial infarction compared with conventional propofol sedation
Other end-points of the trial are potential renal protective effects measured with cystatin C levels need for dialysis but also measurements of inorganic fluorides in serum as well as environmental aspects of sevoflurane sedation in a Cardiothoracic Intensive Care Unit Furthermore potential differences in ICU memories and well-being during stay in the intensive Care Unit will be investigated via patient questionnaires
Besides routine blood sampling plasma will be saved for later analysis of inflammatory mediators biobank
Detailed Description:
Sevoflurane an inhaled anesthetic is currently recommended for anesthesia during coronary artery bypass grafting CABG
Inhaled sevoflurane during CABG reduces postoperative Troponin levels and may be associated with improved outcome A dose-response effect of Sevoflurane cardioprotection has been demonstrated by de Hert et al with greatest reductions of Troponin when Sevoflurane was used during the entire operation as compared to Sevoflurane during parts of the operation or not at all
Postoperative sedation after CABG is currently achieved with intravenous propofol
Sevoflurane as other inhaled anesthetic agents is sedative in low doses A new simplified method of administration of isoflurane or sevoflurane has been developed and tested by members of the research group The Anesthetic Conserving Device AnaConDa is a modified heat-moisture exchanger HME that permits direct infusion of sevoflurane to the airway where it is vaporized in an evaporator rod in the device Studies of isoflurane sedation with the AnaConDa have shown good sedation effects and short wake-up times
The primary aim and primary hypothesisof the current trial is to examine if postoperative sedation with sevoflurane after CABG is associated with improved cardiac outcome measured as reduced levels of Troponin BNP and reduced incidence of cardiac events such as atrial fibrillation need for inotropic drugs and myocardial infarction compared with conventional propofol sedation
Other end-points of the trial are potential renal protective effects measured with cystatin C levels need for dialysis but also measurements of inorganic fluorides in serum as well as environmental aspects of sevoflurane sedation in a Cardiothoracic Intensive Care Unit Furthermore potential differences in ICU memories and well-being during stay in the intensive Care Unit will be investigated via patient questionnaires
Besides routine blood sampling plasma will be saved for later analysis of inflammatory mediators biobank
Methods
120 patients planned for CABG without valve surgery will be enrolled in the trial Patients with malignant hyperthermia are excluded as well as patients with need for mechanical circulation support
Routine anesthesia and CABG will be followed by randomisation to either inhaled sevoflurane or intravenous propofol Patients will be transferred from the operating room to the Cardiothoracic Intensive Care Unit CICUwith propofol sedation Upon arrival to the CICU sedation will according to randomisation will replace propofol
Thereafter patients will be kept sedated according to the MAAS Scale until vital parameters are stable and extubation criteria are fulfilled or for a maximum of 48 hours Time from arrival at CICU to extubation as well as time from termination of sedative to extubation will be measured Total time in CICU will be recorded as well as time from arrival to discharge criteria are fulfilled
Troponin BNP Creatinine Cystatin C CRP will be measured before CABG and at regular time intervals postoperatively A blood sample for storage of plasma will be taken 12 hours postoperatively preliminary for measurement of interleukin activity as this may be attenuated by inhaled anesthetics Hemodynamics will be recorded during CICU care as well as need for inotropic drugs cardioversion arrythmias or adverse events
Environment will be monitored with dosimeter measurements and with spectrophotometry
After extubation patients will be monitored regarding cognitive recovery during the first hour When discharged from the CICU patients will receive a questionnaire in order to describe the memory panorama from the ICU stay after 1-2 days
Inhaled sevoflurane during CABG reduces postoperative Troponin levels and may be associated with improved outcome A dose-response effect of Sevoflurane cardioprotection has been demonstrated by de Hert et al with greatest reductions of Troponin when Sevoflurane was used during the entire operation as compared to Sevoflurane during parts of the operation or not at all
Postoperative sedation after CABG is currently achieved with intravenous propofol
Sevoflurane as other inhaled anesthetic agents is sedative in low doses A new simplified method of administration of isoflurane or sevoflurane has been developed and tested by members of the research group The Anesthetic Conserving Device AnaConDa is a modified heat-moisture exchanger HME that permits direct infusion of sevoflurane to the airway where it is vaporized in an evaporator rod in the device Studies of isoflurane sedation with the AnaConDa have shown good sedation effects and short wake-up times
The primary aim and primary hypothesisof the current trial is to examine if postoperative sedation with sevoflurane after CABG is associated with improved cardiac outcome measured as reduced levels of Troponin BNP and reduced incidence of cardiac events such as atrial fibrillation need for inotropic drugs and myocardial infarction compared with conventional propofol sedation
Other end-points of the trial are potential renal protective effects measured with cystatin C levels need for dialysis but also measurements of inorganic fluorides in serum as well as environmental aspects of sevoflurane sedation in a Cardiothoracic Intensive Care Unit Furthermore potential differences in ICU memories and well-being during stay in the intensive Care Unit will be investigated via patient questionnaires
Besides routine blood sampling plasma will be saved for later analysis of inflammatory mediators biobank
Methods
120 patients planned for CABG without valve surgery will be enrolled in the trial Patients with malignant hyperthermia are excluded as well as patients with need for mechanical circulation support
Routine anesthesia and CABG will be followed by randomisation to either inhaled sevoflurane or intravenous propofol Patients will be transferred from the operating room to the Cardiothoracic Intensive Care Unit CICUwith propofol sedation Upon arrival to the CICU sedation will according to randomisation will replace propofol
Thereafter patients will be kept sedated according to the MAAS Scale until vital parameters are stable and extubation criteria are fulfilled or for a maximum of 48 hours Time from arrival at CICU to extubation as well as time from termination of sedative to extubation will be measured Total time in CICU will be recorded as well as time from arrival to discharge criteria are fulfilled
Troponin BNP Creatinine Cystatin C CRP will be measured before CABG and at regular time intervals postoperatively A blood sample for storage of plasma will be taken 12 hours postoperatively preliminary for measurement of interleukin activity as this may be attenuated by inhaled anesthetics Hemodynamics will be recorded during CICU care as well as need for inotropic drugs cardioversion arrythmias or adverse events
Environment will be monitored with dosimeter measurements and with spectrophotometry
After extubation patients will be monitored regarding cognitive recovery during the first hour When discharged from the CICU patients will receive a questionnaire in order to describe the memory panorama from the ICU stay after 1-2 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None