Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00528515
Status:
COMPLETED
Last Update Posted:
2008-05-16
First Post:
2007-09-11
Brief Title:
Desflurane Versus Propofol Anesthesia for Off-Pump CABG
Sponsor:
Medical University of Gdansk
Organization:
Medical University of Gdansk
Study Overview
Official Title:
Comparison of Desflurane and Propofol Anesthesia for Off-Pump Coronary Artery Bypass Grafting Surgery
Status:
COMPLETED
Status Verified Date:
2008-05
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:
The purpose of this study is to prove if anesthesia maintained with the inhaled volatile anesthetic desflurane is superior to the intravenously applied propofol anesthesia in off-pump coronary artery bypass grafting OP-CABG surgery as measured by following parameters
1 hemodynamic parameters during and after the operation
2 pulmonary gas exchange need for mechanical ventilation and for ICU and intrahospital stay
3 release of heart muscle injury markers in response to surgery and intraoperative ischaemia
4 inflammatory response to the operation
We suspect that insufflation anesthesia with desflurane may be superior to intravenous anesthesia with propofol
1 hemodynamic parameters during and after the operation
2 pulmonary gas exchange need for mechanical ventilation and for ICU and intrahospital stay
3 release of heart muscle injury markers in response to surgery and intraoperative ischaemia
4 inflammatory response to the operation
We suspect that insufflation anesthesia with desflurane may be superior to intravenous anesthesia with propofol
Detailed Description:
General anesthesia will be induced by intravenous dosis of fentanyl vecuronium and etomidate and further maintained either by inhaled desflurane or propofol infusion with concomitant empirically administered fentanyl doses and continuous infusion of vecuronium
After induction of anesthesia a Swan-Ganz catheter for continuous cardiac output right ventricle end diastolic volume and blood saturation measurements will be introduced through the internal jugular vein A transesophageal echocardiography probe will be placed additionally for the Tei-index measurement
Hemodynamic parameters will be recorded at the following time points
before induction
after induction
during trachea intubation
before skin incision
3 Min after skin incision
after sternotomy
before heart positioning for graft placing
before finishing placing each distal anastomoses
10 20 30 40 min after placing the last anastomoses
10 Min after admission to ICU 6 12 18 and 24 hours after surgery
TEE measurements will be obtained after sternotomy and 20 Min after placing the last distal anastomoses
The results will be compared while using the parametric ANOVA test for normally distributed continuous data or the nonparametric Kruskal-WallisWilcoxon-U test for categoric or inhomogeneous distributed continuous data
After induction of anesthesia a Swan-Ganz catheter for continuous cardiac output right ventricle end diastolic volume and blood saturation measurements will be introduced through the internal jugular vein A transesophageal echocardiography probe will be placed additionally for the Tei-index measurement
Hemodynamic parameters will be recorded at the following time points
before induction
after induction
during trachea intubation
before skin incision
3 Min after skin incision
after sternotomy
before heart positioning for graft placing
before finishing placing each distal anastomoses
10 20 30 40 min after placing the last anastomoses
10 Min after admission to ICU 6 12 18 and 24 hours after surgery
TEE measurements will be obtained after sternotomy and 20 Min after placing the last distal anastomoses
The results will be compared while using the parametric ANOVA test for normally distributed continuous data or the nonparametric Kruskal-WallisWilcoxon-U test for categoric or inhomogeneous distributed continuous data
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