Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl

NCT01384175 | Completed

• 1 other identifier: OPCAB-EA
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease

Keywords

Epidural Analgesia; OPCAB; PCEA

Outcome Measures

Primary Outcomes (1)

• Duration of postoperative mechanical ventilation

  Duration of postoperative mechanical ventilation, hours

  Participants will be followed for the duration of mechanical ventilation, an expected average of 6 hours

Secondary Outcomes (1)

• Hemodynamic stability

  All period of operation and during 24 hours postoperatively

Study Arms (3)

intravenous analgesia

ACTIVE COMPARATOR

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

Procedure: intravenous analgesia

epiduaral infusion

ACTIVE COMPARATOR

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

patient-controlled epidural analgesia

ACTIVE COMPARATOR

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

Interventions

intravenous analgesia PROCEDURE

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

intravenous analgesia

epidural infusion PROCEDURE

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

epiduaral infusion

patient-controlled epidural analgesia PROCEDURE

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.

patient-controlled epidural analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presence of coronary artery disease
• ASA II-III
• elective off-pump coronary artery bypass

You may not qualify if:

• age \< 18 years
• severe valve dysfunction or peripheral vascular disease
• simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.)
• transfer to CPB during surgery

Sponsors & Collaborators

• Northern State Medical University: lead
• University of Tromso: collaborator

Study Sites (1)

Dep. of Anesthesiology, Northern SMU

Arkhangelsk, Russia

Location

Related Publications (1)

• 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.

  PMID: 21923942 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Mikhail Y Kirov

  Northern State Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 17, 2011
• First Posted: June 28, 2011
• Study Start: January 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: June 29, 2011

Record last verified: 2011-06

Locations

RU (1)