- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00528515
Desflurane Versus Propofol Anesthesia for Off-Pump CABG
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Gdańsk, Poland, 80-211
- Department of Cadiac Anesthesiology, Medical University of Gdańsk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
propofol
|
continuous intravenous infusion with a dose of 3-5 mg/kg/h
Other Names:
|
Experimental: 2
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
within the first 2. days after surgery.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
To discharge from hospital (usually within 7 days)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Romuald Lango, M.D., Ph.D., Medical University of Gdańsk, Department of Cardiac Anesthesiology
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Hypnotics and Sedatives
- Anesthetics, Inhalation
- Propofol
- Desflurane
Other Study ID Numbers
- AMG-NKEBN/364-A/2005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina
Clinical Trials on Diprivan (propofol), Astra-Zeneca
-
Hopital FochCompleted
-
Great Ormond Street Hospital for Children NHS Foundation...CompletedIdiopathic Scoliosis | Spine Deformities | Neuromuscular DystrophyUnited Kingdom
-
Medical University of GdanskWithdrawnMemory Disorders | Other Functional Disturbances Following Cardiac SurgeryPoland
-
National Research Centre, EgyptTheodor Bilharz Research Institute; The holding company for biological products...RecruitingImmune Response to Covid 19 VaccinationEgypt
-
National Taiwan University HospitalTaoyuan General Hospital, Ministry of Health and Welfare,Taoyuan,TaiwanCompletedHealthy Adult VolunteersTaiwan
-
Asan Medical CenterCompletedPopulation Pharmacokinetics/Pharmacodynamics (PK/PD) of Microemulsion Propofol in Healthy VolunteersHealthyKorea, Republic of
-
Assistance Publique - Hôpitaux de ParisRecruiting
-
Vinbiocare Biotechnology Joint Stock CompanyArcturus Therapeutics, Inc.CompletedCOVID-19 VaccinesVietnam
-
Indiana UniversityAstraZenecaCompletedPanic DisorderUnited States
-
Loma Linda UniversityCompletedMajor DepressionUnited States