Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl
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|ClinicalTrials.gov Identifier: NCT01384175|
Recruitment Status : Completed
First Posted : June 28, 2011
Last Update Posted : June 29, 2011
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Procedure: intravenous analgesia Procedure: epidural infusion Procedure: patient-controlled epidural analgesia||Not Applicable|
|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|
|Actual Primary Completion Date :||August 2009|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|