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Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
intravenous analgesia
epidural infusion
patient-controlled epidural analgesia
Sponsored by
Northern State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Epidural Analgesia, OPCAB, PCEA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dep. of Anesthesiology, Northern SMU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

intravenous analgesia

epiduaral infusion

patient-controlled epidural analgesia

Arm Description

Patients received postoperative analgesia by intravenous fentanyl 10 µg/ml 3-8 mL/h.

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.

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.

Outcomes

Primary Outcome Measures

Duration of postoperative mechanical ventilation
Duration of postoperative mechanical ventilation, hours

Secondary Outcome Measures

Hemodynamic stability
Hemodynamic stability as assessed by mean arterial pressure, heart rate, cardiac index, requirement of inotrops/vasoactives and colloids

Full Information

First Posted
June 17, 2011
Last Updated
June 28, 2011
Sponsor
Northern State Medical University
Collaborators
University of Tromso
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1. Study Identification

Unique Protocol Identification Number
NCT01384175
Brief Title
Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl
Official Title
Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl in Off-pump Coronary Artery Bypass Grafting
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Northern State Medical University
Collaborators
University of Tromso

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Epidural Analgesia, OPCAB, PCEA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intravenous analgesia
Arm Type
Active Comparator
Arm Description
Patients received postoperative analgesia by intravenous fentanyl 10 µg/ml 3-8 mL/h.
Arm Title
epiduaral infusion
Arm Type
Active Comparator
Arm Description
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.
Arm Title
patient-controlled epidural analgesia
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
intravenous analgesia
Intervention Description
Patients received postoperative analgesia with intravenous infusion of fentanyl 10 µg/ml 3-8 mL/h
Intervention Type
Procedure
Intervention Name(s)
epidural infusion
Intervention Description
Postoperative analgesia was performed using continuous epidural infusion of ropivacaine 0.2% 3-8 mL/h and fentanyl 2 µg/mL
Intervention Type
Procedure
Intervention Name(s)
patient-controlled epidural analgesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Duration of postoperative mechanical ventilation
Description
Duration of postoperative mechanical ventilation, hours
Time Frame
Participants will be followed for the duration of mechanical ventilation, an expected average of 6 hours
Secondary Outcome Measure Information:
Title
Hemodynamic stability
Description
Hemodynamic stability as assessed by mean arterial pressure, heart rate, cardiac index, requirement of inotrops/vasoactives and colloids
Time Frame
All period of operation and during 24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikhail Y Kirov
Organizational Affiliation
Northern State Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Dep. of Anesthesiology, Northern SMU
City
Arkhangelsk
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
21923942
Citation
Kirov MY, Eremeev AV, Smetkin AA, Bjertnaes LJ. Epidural anesthesia and postoperative analgesia with ropivacaine and fentanyl in off-pump coronary artery bypass grafting: a randomized, controlled study. BMC Anesthesiol. 2011 Sep 18;11:17. doi: 10.1186/1471-2253-11-17.
Results Reference
derived

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Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl

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