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Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl

Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl in Off-pump Coronary Artery Bypass Grafting

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01384175
Enrollment
93
Registered
2011-06-28
Start date
2008-01-31
Completion date
2009-09-30
Last updated
2011-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Epidural Analgesia, OPCAB, PCEA

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.

Interventions

Patients received postoperative analgesia with intravenous infusion of fentanyl 10 µg/ml 3-8 mL/h

Postoperative analgesia was performed using continuous epidural infusion of ropivacaine 0.2% 3-8 mL/h and fentanyl 2 µg/mL

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.

Sponsors

University of Tromso
CollaboratorOTHER
Northern State Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Duration of postoperative mechanical ventilationParticipants will be followed for the duration of mechanical ventilation, an expected average of 6 hoursDuration of postoperative mechanical ventilation, hours

Secondary

MeasureTime frameDescription
Hemodynamic stabilityAll period of operation and during 24 hours postoperativelyHemodynamic stability as assessed by mean arterial pressure, heart rate, cardiac index, requirement of inotrops/vasoactives and colloids

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026