Desflurane Versus Propofol Anesthesia for Off-Pump CABG
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Diprivan (propofol), Astra-Zeneca
Suprane (desflurane), Baxter
Sponsored by
About this trial
This is an interventional supportive care trial for Coronary Artery Disease focused on measuring anesthesia intravenous, propofol, anesthesia inhalation, desflurane, heart surgery, coronary artery by-pass off-pump, hemodynamic processes, anesthesia
Eligibility Criteria
Inclusion Criteria:
- Patients with coronary artery disease qualified for CABG off-pump surgery
- Elective surgery
- Signed informed consent
Exclusion Criteria:
- Left ventricle ejection fraction < 30%
- Serum creatinine > 2 mg/dL
- Emergency surgery
- Denied consent
Sites / Locations
- Department of Cadiac Anesthesiology, Medical University of Gdańsk
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
propofol
desflurane
Outcomes
Primary Outcome Measures
Markers of heart muscle injury and inflammation will be compared: troponin I, creatinine phosphokinase and its heart specific fraction, C-reactive protein.
Secondary Outcome Measures
Evidence of clinically definite heart infarct confirmed by ECG and/or echocardiography, and heart muscle specific creatinine phosphokinase increase.
Full Information
NCT ID
NCT00528515
First Posted
September 11, 2007
Last Updated
May 15, 2008
Sponsor
Medical University of Gdansk
1. Study Identification
Unique Protocol Identification Number
NCT00528515
Brief Title
Desflurane Versus Propofol Anesthesia for Off-Pump CABG
Official Title
Comparison of Desflurane and Propofol Anesthesia for Off-Pump Coronary Artery Bypass Grafting Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Gdansk
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
anesthesia intravenous, propofol, anesthesia inhalation, desflurane, heart surgery, coronary artery by-pass off-pump, hemodynamic processes, anesthesia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
propofol
Arm Title
2
Arm Type
Experimental
Arm Description
desflurane
Intervention Type
Drug
Intervention Name(s)
Diprivan (propofol), Astra-Zeneca
Other Intervention Name(s)
propofol
Intervention Description
continuous intravenous infusion with a dose of 3-5 mg/kg/h
Intervention Type
Drug
Intervention Name(s)
Suprane (desflurane), Baxter
Other Intervention Name(s)
desflurane
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with coronary artery disease qualified for CABG off-pump surgery
Elective surgery
Signed informed consent
Exclusion Criteria:
Left ventricle ejection fraction < 30%
Serum creatinine > 2 mg/dL
Emergency surgery
Denied consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romuald Lango, M.D., Ph.D.
Organizational Affiliation
Medical University of Gdańsk, Department of Cardiac Anesthesiology
Official's Role
Study Director
Facility Information:
Facility Name
Department of Cadiac Anesthesiology, Medical University of Gdańsk
City
Gdańsk
ZIP/Postal Code
80-211
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
15087655
Citation
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.
Results Reference
background
PubMed Identifier
17156509
Citation
Tritapepe 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.
Results Reference
background
PubMed Identifier
16884976
Citation
Guarracino 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.
Results Reference
background
PubMed Identifier
12883404
Citation
De 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.
Results Reference
background
PubMed Identifier
24643920
Citation
Mrozinski 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.
Results Reference
derived
Links:
URL
http://www.amg.gda.pl/uczelnia/informator/projekty.php?id=327
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Desflurane Versus Propofol Anesthesia for Off-Pump CABG
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