Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl
|ClinicalTrials.gov Identifier: NCT01384175|
Recruitment Status : Completed
First Posted : June 28, 2011
Last Update Posted : June 29, 2011
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease||Procedure: intravenous analgesia Procedure: epidural infusion Procedure: patient-controlled epidural analgesia|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl in Off-pump Coronary Artery Bypass Grafting|
|Study Start Date :||January 2008|
|Primary Completion Date :||August 2009|
|Study Completion Date :||September 2009|
Active Comparator: intravenous analgesia
Patients received postoperative analgesia by intravenous fentanyl 10 µg/ml 3-8 mL/h.
Procedure: intravenous analgesia
Patients received postoperative analgesia with intravenous infusion of fentanyl 10 µg/ml 3-8 mL/h
Active Comparator: epiduaral infusion
Patients received epidural analgesia intraoperatively with ropivacaine 0.75% 1 mg/kg and fentanyl 1 µg/kg followed by continuous epidural infusion of ropivacaine 0.2% 3-8 mL/h and fentanyl 2 µg/mL postoperatively.
Procedure: epidural infusion
Postoperative analgesia was performed using continuous epidural infusion of ropivacaine 0.2% 3-8 mL/h and fentanyl 2 µg/mL
Active Comparator: patient-controlled epidural analgesia
In addition to epidural anesthesia and epidural infusion, postoperatively patients received patient-controlled epidural analgesia with ropivacaine/fentanyl bolus 1 mL, lock-out interval 12 min.
Procedure: patient-controlled epidural analgesia
Postoperative analgesia was performed by continuous epidural infusion of ropivacaine/fentanyl mixture combined with patient-controlled epidural analgesia with ropivacaine/fentanyl bolus 1 mL, lock-out interval 12 min.
- Duration of postoperative mechanical ventilation [ Time Frame: Participants will be followed for the duration of mechanical ventilation, an expected average of 6 hours ]Duration of postoperative mechanical ventilation, hours
- Hemodynamic stability [ Time Frame: All period of operation and during 24 hours postoperatively ]Hemodynamic stability as assessed by mean arterial pressure, heart rate, cardiac index, requirement of inotrops/vasoactives and colloids
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01384175
|Dep. of Anesthesiology, Northern SMU|
|Arkhangelsk, Russian Federation|
|Study Director:||Mikhail Y Kirov||Northern State Medical University|