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Clinical Trials/NCT01384175
NCT01384175
Completed
Not Applicable

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

Northern State Medical University1 site in 1 country93 target enrollmentJanuary 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Northern State Medical University
Enrollment
93
Locations
1
Primary Endpoint
Duration of postoperative mechanical ventilation
Status
Completed
Last Updated
14 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
September 2009
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Northern State Medical University

Eligibility Criteria

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

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)

Study Sites (1)

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