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Sponsored by: |
Medical University of Gdansk |
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Information provided by: | Medical University of Gdansk |
ClinicalTrials.gov Identifier: | NCT00528515 |
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:
We suspect that insufflation anesthesia with desflurane may be superior to intravenous anesthesia with propofol.
Condition | Intervention | Phase |
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Coronary Artery Disease |
Drug: Diprivan (propofol), Astra-Zeneca Drug: Suprane (desflurane), Baxter |
Phase IV |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of Desflurane and Propofol Anesthesia for Off-Pump Coronary Artery Bypass Grafting Surgery |
Enrollment: | 80 |
Study Start Date: | February 2007 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
propofol
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Drug: Diprivan (propofol), Astra-Zeneca
continuous intravenous infusion with a dose of 3-5 mg/kg/h
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2: Experimental
desflurane
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Drug: Suprane (desflurane), Baxter
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.
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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:
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Poland | |
Department of Cadiac Anesthesiology, Medical University of Gdańsk | |
Gdańsk, Poland, 80-211 |
Study Director: | Romuald Lango, M.D., Ph.D. | Medical University of Gdańsk, Department of Cardiac Anesthesiology |
Responsible Party: | Medical University of Gdańsk, Dept. of Cardiac Anesthesiology ( Romuald Lango MD, PhD ) |
Study ID Numbers: | AMG-NKEBN/364-A/2005 |
Study First Received: | September 11, 2007 |
Last Updated: | May 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00528515 |
Health Authority: | Poland: Ministry of Scientific Research and Information Technology |
anesthesia intravenous propofol anesthesia inhalation desflurane |
heart surgery coronary artery by-pass off-pump hemodynamic processes anesthesia |
Arterial Occlusive Diseases Coronary Disease Desflurane Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Propofol Coronary Artery Disease |
Anesthetics, Intravenous Anesthetics, Inhalation Anesthetics, General Therapeutic Uses Hypnotics and Sedatives Physiological Effects of Drugs |
Central Nervous System Depressants Anesthetics Cardiovascular Diseases Central Nervous System Agents Pharmacologic Actions |