Coronary Artery DiseaseNCT01384175
Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl
A study testing intravenous analgesia and epidural infusion in people with Coronary Artery Disease, run by Northern State Medical University at 1 site in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- intravenous analgesia and epidural infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2008to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of coronary artery disease
- ASA II-III
- elective off-pump coronary artery bypass
Who cannot join
- age < 18 years
- severe valve dysfunction or peripheral vascular disease
- simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.)
- transfer to CPB during surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl in Off-pump Coronary Artery Bypass Grafting
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
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- intravenous analgesia, epidural infusion, patient-controlled epidural analgesia
- Keywords
- Epidural Analgesia, OPCAB, PCEA
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous analgesiaProcedure or surgery
Patients received postoperative analgesia with intravenous infusion of fentanyl 10 µg/ml 3-8 mL/h
epidural infusionProcedure or surgery
Postoperative analgesia was performed using continuous epidural infusion of ropivacaine 0.2% 3-8 mL/h and fentanyl 2 µg/mL
patient-controlled epidural analgesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| intravenous analgesia | Active comparator | Patients received postoperative analgesia by intravenous fentanyl 10 µg/ml 3-8 mL/h. Receives: 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. Receives: 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. Receives: Procedure: patient-controlled epidural analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of postoperative mechanical ventilation
Duration of postoperative mechanical ventilation, hours
Measured: Participants will be followed for the duration of mechanical ventilation, an expected average of 6 hours
Secondary outcomes (1)
Hemodynamic stability
Hemodynamic stability as assessed by mean arterial pressure, heart rate, cardiac index, requirement of inotrops/vasoactives and colloids
Measured: All period of operation and during 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startJan 2008
- Primary completionAug 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern State Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso
- Investigators
- Mikhail Y Kirov, Study director, Northern State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384175
- Sponsor's protocol ID
- OPCAB-EA
- Status last verified
- Jun 2011
- First submitted
- 17 Jun 2011
- Last updated
- 29 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21923942
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl in Off-pump Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT01384175
- Acronym / sponsor ID
- OPCAB-EA
- Conditions
- Coronary Artery Disease
- Keywords
- Epidural Analgesia, OPCAB, PCEA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Northern State Medical UniversityUniversity, hospital or other
- Collaborators
- University of Tromso
- Study start
- Jan 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 28 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intravenous analgesia | Active comparator | Procedure: intravenous analgesiaPatients received postoperative analgesia by intravenous fentanyl 10 µg/ml 3-8 mL/h. |
| epiduaral infusion | Active comparator | Procedure: epidural infusionPatients 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. |
| patient-controlled epidural analgesia | Active comparator | Procedure: patient-controlled epidural analgesiaIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- presence of coronary artery disease
- ASA II-III
- elective off-pump coronary artery bypass
Key exclusion criteria (4 listed)
- age < 18 years
- severe valve dysfunction or peripheral vascular disease
- simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.)
- transfer to CPB during surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous analgesiaPatients received postoperative analgesia with intravenous infusion of fentanyl 10 µg/ml 3-8 mL/h | Procedure or surgery | intravenous analgesia |
| epidural infusionPostoperative analgesia was performed using continuous epidural infusion of ropivacaine 0.2% 3-8 mL/h and fentanyl 2 µg/mL | Procedure or surgery | epiduaral infusion |
| patient-controlled epidural analgesiaPostoperative 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. | Procedure or surgery | patient-controlled epidural analgesia |
Primary outcome
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
1 secondary outcome
Hemodynamic stability
Time frame: All period of operation and during 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2011.
- Derived from this study: PubMed 21923942Kirov 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail Y Kirov study director
Northern State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravenous analgesia and epidural infusion in people with Coronary Artery Disease, run by Northern State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of postoperative mechanical ventilation (time frame: Participants will be followed for the duration of mechanical ventilation, an expected average of 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01384175, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2011.