Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl in Off-pump Coronary Artery Bypass Grafting
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 93
- Locations
- 2
- Primary Endpoint
- Duration of postoperative mechanical ventilation
Study Overview
Brief Summary
The aim of the present study was to assess the efficacy of thoracic epidural anesthesia followed by postoperative epidural infusion and patient-controlled epidural analgesia with ropivacaine/fentanyl in off-pump coronary artery bypass grafting
Detailed Description
Ninety-three patients were scheduled for off-pump coronary artery bypass (OPCAB) under propofol/fentanyl anesthesia. Day before surgery patients were asked for informed consent and randomized into three postoperative analgesia regimens aiming at a visual analog scale (VAS) score <30 mm at rest. The control group (n=31) received intravenous fentanyl 10 µg/ml postoperatively 3-8 mL/h. After placement of an epidural catheter at the level of Th2-Th4 before OPCAB, a thoracic epidural infusion (EI) group (n=31) received epidural anesthesia (EA) intraoperatively with ropivacaine 0.75% 1 mg/kg and fentanyl 1 µg/kg followed by continuous EI of ropivacaine 0.2% 3-8 mL/h and fentanyl 2 µg/mL postoperatively. The patient-controlled epidural analgesia (PCEA) group (n=31), in addition to EA and EI, received PCEA (ropivacaine/fentanyl bolus 1 mL, lock-out interval 12 min) postoperatively. Hemodynamics and blood gases were measured throughout 24 h after OPCAB.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •presence of coronary artery disease
- •ASA II-III
- •elective off-pump coronary artery bypass
Exclusion Criteria
- •age < 18 years
- •severe valve dysfunction or peripheral vascular disease
- •simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.)
- •transfer to CPB during surgery
Arms & Interventions
intravenous analgesia
Patients received postoperative analgesia by intravenous fentanyl 10 µg/ml 3-8 mL/h.
Intervention: intravenous analgesia (Procedure)
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.
Intervention: epidural infusion (Procedure)
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.
Intervention: patient-controlled epidural analgesia (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Hemodynamic stability(All period of operation and during 24 hours postoperatively)