Coronary Artery DiseasePhase 4NCT00528515
Desflurane Versus Propofol Anesthesia for Off-Pump CABG
A Phase 4 study testing Diprivan (propofol), Astra-Zeneca and Suprane (desflurane), Baxter in people with Coronary Artery Disease, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
The purpose of this study is to prove if anesthesia maintained with the inhaled volatile anesthetic desflurane is superior to the intravenously applied propofol anesthesia in off-pump coronary artery bypass grafting (OP-CABG) surgery as measured by following parameters: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Diprivan (propofol), Astra-Zeneca and Suprane (desflurane), Baxter
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2007to Mar 2008
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with coronary artery disease qualified for CABG off-pump surgery
- Elective surgery
- Signed informed consent
Who cannot join
- Left ventricle ejection fraction < 30%
- Serum creatinine > 2 mg/dL
- Emergency surgery
- Denied consent
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Cadiac Anesthesiology, Medical University of Gdańsk
Gdansk, 80-211
About this study
Official title: Comparison of Desflurane and Propofol Anesthesia for Off-Pump Coronary Artery Bypass Grafting Surgery
The purpose of this study is to prove if anesthesia maintained with the inhaled volatile anesthetic desflurane is superior to the intravenously applied propofol anesthesia in off-pump coronary artery bypass grafting (OP-CABG) surgery as measured by following parameters:
- hemodynamic parameters during and after the operation,
- pulmonary gas exchange, need for mechanical ventilation and for ICU and intrahospital stay,
- release of heart muscle injury markers in response to surgery and intraoperative ischaemia,
- inflammatory response to the operation.
We suspect that insufflation anesthesia with desflurane may be superior to intravenous anesthesia with propofol.
Read the detailed description
General anesthesia will be induced by intravenous dosis of fentanyl, vecuronium and etomidate and further maintained either by inhaled desflurane or propofol infusion, with concomitant empirically administered fentanyl doses and continuous infusion of vecuronium.
After induction of anesthesia a Swan-Ganz catheter for continuous cardiac output, right ventricle end diastolic volume and blood saturation measurements will be introduced through the internal jugular vein. A transesophageal echocardiography probe will be placed additionally for the Tei-index measurement.
Hemodynamic parameters will be recorded at the following time points:
- before induction
- after induction
- during trachea intubation
- before skin incision
- 3 Min. after skin incision
- after sternotomy
- before heart positioning for graft placing
- before finishing placing each distal anastomoses
- 10, 20, 30, 40 min after placing the last anastomoses
- 10 Min. after admission to ICU, 6, 12, 18 and 24 hours after surgery.
- TEE measurements will be obtained after sternotomy and 20 Min after placing the last distal anastomoses.
The results will be compared while using the parametric ANOVA test for normally distributed continuous data or the nonparametric Kruskal-Wallis/Wilcoxon-U test for categoric or inhomogeneous distributed continuous data.
- Conditions
- Coronary Artery Disease
- Being tested
- Diprivan (propofol), Astra-Zeneca, Suprane (desflurane), Baxter
- Keywords
- anesthesia intravenous, propofol, anesthesia inhalation, desflurane, heart surgery, coronary artery by-pass off-pump, hemodynamic processes, anesthesia
- 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.
Diprivan (propofol), Astra-ZenecaDrug
Also called propofol
continuous intravenous infusion with a dose of 3-5 mg/kg/h
Suprane (desflurane), BaxterDrug
Also called desflurane
a vapor concentration of 3-7 vol% is maintained with use of vaporizer and under control of arterial blood pressure, heart rate, and BIS index.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | propofol Receives: Drug: Diprivan (propofol), Astra-Zeneca |
| 2 | Experimental | desflurane Receives: Drug: Suprane (desflurane), Baxter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of heart muscle injury and inflammation will be compared: troponin I, creatinine phosphokinase and its heart specific fraction, C-reactive protein.
Measured: within the first 2. days after surgery.
Secondary outcomes (1)
Evidence of clinically definite heart infarct confirmed by ECG and/or echocardiography, and heart muscle specific creatinine phosphokinase increase.
Measured: To discharge from hospital (usually within 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
- Study startFeb 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Investigators
- Romuald Lango, M.D., Ph.D., Study director, Medical University of Gdańsk, Department of Cardiac Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528515
- Sponsor's protocol ID
- AMG-NKEBN/364-A/2005
- Status last verified
- May 2008
- First submitted
- 11 Sep 2007
- Last updated
- 16 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Xia Z, Luo T. Sevoflurane or desflurane anesthesia plus postoperative propofol sedation attenuates myocardial injury after coronary surgery in elderly high-risk patients. Anesthesiology. 2004 Apr;100(4):1038-9; author reply 1039-40. doi: 10.1097/00000542-200404000-00050. No abstract available.
PubMed 15087655Tritapepe L, Landoni G, Guarracino F, Pompei F, Crivellari M, Maselli D, De Luca M, Fochi O, D'Avolio S, Bignami E, Calabro MG, Zangrillo A. Cardiac protection by volatile anaesthetics: a multicentre randomized controlled study in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass. Eur J Anaesthesiol. 2007 Apr;24(4):323-31. doi: 10.1017/S0265021506001931. Epub 2006 Dec 8.
PubMed 17156509Guarracino F, Landoni G, Tritapepe L, Pompei F, Leoni A, Aletti G, Scandroglio AM, Maselli D, De Luca M, Marchetti C, Crescenzi G, Zangrillo A. Myocardial damage prevented by volatile anesthetics: a multicenter randomized controlled study. J Cardiothorac Vasc Anesth. 2006 Aug;20(4):477-83. doi: 10.1053/j.jvca.2006.05.012.
PubMed 16884976De Hert SG, Cromheecke S, ten Broecke PW, Mertens E, De Blier IG, Stockman BA, Rodrigus IE, Van der Linden PJ. Effects of propofol, desflurane, and sevoflurane on recovery of myocardial function after coronary surgery in elderly high-risk patients. Anesthesiology. 2003 Aug;99(2):314-23. doi: 10.1097/00000542-200308000-00013.
PubMed 12883404Mrozinski P, Lango R, Biedrzycka A, Kowalik MM, Pawlaczyk R, Rogowski J. Comparison of haemodynamics and myocardial injury markers under desflurane vs. propofol anaesthesia for off-pump coronary surgery. A prospective randomised trial. Anaesthesiol Intensive Ther. 2014 Jan-Mar;46(1):4-13. doi: 10.5603/AIT.2014.0002.
PubMed 24643920
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Desflurane and Propofol Anesthesia for Off-Pump Coronary Artery Bypass Grafting Surgery
- ClinicalTrials.gov ID
- NCT00528515
- Acronym / sponsor ID
- AMG-NKEBN/364-A/2005
- Conditions
- Coronary Artery Disease
- Keywords
- anesthesia intravenous, propofol, anesthesia inhalation, desflurane, heart surgery, coronary artery by-pass off-pump, hemodynamic processes, anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 12 Sep 2007 (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 purpose of this study is to prove if anesthesia maintained with the inhaled volatile anesthetic desflurane is superior to the intravenously applied propofol anesthesia in off-pump coronary artery bypass grafting (OP-CABG) surgery as measured by following parameters:
- hemodynamic parameters during and after the operation,
- pulmonary gas exchange, need for mechanical ventilation and for ICU and intrahospital stay,
- release of heart muscle injury markers in response to surgery and intraoperative ischaemia,
- inflammatory response to the operation.
We suspect that insufflation anesthesia with desflurane may be superior to intravenous anesthesia with propofol.
Detailed description
General anesthesia will be induced by intravenous dosis of fentanyl, vecuronium and etomidate and further maintained either by inhaled desflurane or propofol infusion, with concomitant empirically administered fentanyl doses and continuous infusion of vecuronium.
After induction of anesthesia a Swan-Ganz catheter for continuous cardiac output, right ventricle end diastolic volume and blood saturation measurements will be introduced through the internal jugular vein. A transesophageal echocardiography probe will be placed additionally for the Tei-index measurement.
Hemodynamic parameters will be recorded at the following time points:
- before induction
- after induction
- during trachea intubation
- before skin incision
- 3 Min. after skin incision
- after sternotomy
- before heart positioning for graft placing
- before finishing placing each distal anastomoses
- 10, 20, 30, 40 min after placing the last anastomoses
- 10 Min. after admission to ICU, 6, 12, 18 and 24 hours after surgery.
- TEE measurements will be obtained after sternotomy and 20 Min after placing the last distal anastomoses.
The results will be compared while using the parametric ANOVA test for normally distributed continuous data or the nonparametric Kruskal-Wallis/Wilcoxon-U test for categoric or inhomogeneous distributed continuous data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Diprivan (propofol), Astra-Zenecapropofol |
| 2 | Experimental | Drug: Suprane (desflurane), Baxterdesflurane |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with coronary artery disease qualified for CABG off-pump surgery
- Elective surgery
- Signed informed consent
Key exclusion criteria (4 listed)
- Left ventricle ejection fraction < 30%
- Serum creatinine > 2 mg/dL
- Emergency surgery
- Denied consent
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 |
|---|---|---|
| Diprivan (propofol), Astra-ZenecaAlso: propofolcontinuous intravenous infusion with a dose of 3-5 mg/kg/h | Drug | 1 |
| Suprane (desflurane), BaxterAlso: desfluranea vapor concentration of 3-7 vol% is maintained with use of vaporizer and under control of arterial blood pressure, heart rate, and BIS index. | Drug | 2 |
Primary outcome
Markers of heart muscle injury and inflammation will be compared: troponin I, creatinine phosphokinase and its heart specific fraction, C-reactive protein.
Time frame: within the first 2. days after surgery.
1 secondary outcome
Evidence of clinically definite heart infarct confirmed by ECG and/or echocardiography, and heart muscle specific creatinine phosphokinase increase.
Time frame: To discharge from hospital (usually within 7 days)
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 16 May 2008.
- Background: PubMed 15087655Xia Z, Luo T. Sevoflurane or desflurane anesthesia plus postoperative propofol sedation attenuates myocardial injury after coronary surgery in elderly high-risk patients. Anesthesiology. 2004 Apr;100(4):1038-9; author reply 1039-40. doi: 10.1097/00000542-200404000-00050. No abstract available.
- Background: PubMed 17156509Tritapepe L, Landoni G, Guarracino F, Pompei F, Crivellari M, Maselli D, De Luca M, Fochi O, D'Avolio S, Bignami E, Calabro MG, Zangrillo A. Cardiac protection by volatile anaesthetics: a multicentre randomized controlled study in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass. Eur J Anaesthesiol. 2007 Apr;24(4):323-31. doi: 10.1017/S0265021506001931. Epub 2006 Dec 8.
- Background: PubMed 16884976Guarracino F, Landoni G, Tritapepe L, Pompei F, Leoni A, Aletti G, Scandroglio AM, Maselli D, De Luca M, Marchetti C, Crescenzi G, Zangrillo A. Myocardial damage prevented by volatile anesthetics: a multicenter randomized controlled study. J Cardiothorac Vasc Anesth. 2006 Aug;20(4):477-83. doi: 10.1053/j.jvca.2006.05.012.
- Background: PubMed 12883404De Hert SG, Cromheecke S, ten Broecke PW, Mertens E, De Blier IG, Stockman BA, Rodrigus IE, Van der Linden PJ. Effects of propofol, desflurane, and sevoflurane on recovery of myocardial function after coronary surgery in elderly high-risk patients. Anesthesiology. 2003 Aug;99(2):314-23. doi: 10.1097/00000542-200308000-00013.
- Derived from this study: PubMed 24643920Mrozinski P, Lango R, Biedrzycka A, Kowalik MM, Pawlaczyk R, Rogowski J. Comparison of haemodynamics and myocardial injury markers under desflurane vs. propofol anaesthesia for off-pump coronary surgery. A prospective randomised trial. Anaesthesiol Intensive Ther. 2014 Jan-Mar;46(1):4-13. doi: 10.5603/AIT.2014.0002.
- Related InfoLink provided by the sponsor.
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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.
Romuald Lango, M.D., Ph.D. study director
Medical University of Gdańsk, Department of Cardiac Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diprivan (propofol), Astra-Zeneca and Suprane (desflurane), Baxter in people with Coronary Artery Disease, run by Medical University of Gdansk at 1 site in Poland.
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 16 May 2008. 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 Poland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Markers of heart muscle injury and inflammation will be compared: troponin I, creatinine phosphokinase and its heart specific fraction, C-reactive protein. (time frame: within the first 2. days after surgery.). 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 NCT00528515, which also lists 5 linked publications.
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 16 May 2008.