Desflurane Versus Propofol Anesthesia for Off-Pump CABG - Full Text View

Sponsored by:	Medical University of Gdansk
Information provided by:	Medical University of Gdansk
ClinicalTrials.gov Identifier:	NCT00528515

Purpose

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.

Condition	Intervention	Phase
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

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Coronary Artery Bypass Surgery Coronary Artery Disease Surgery

Drug Information available for: I 653 Propofol

U.S. FDA Resources

Further study details as provided by Medical University of Gdansk:

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. [ Time Frame: within the first 2. days after surgery. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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) ] [ Designated as safety issue: Yes ]

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
1: Active Comparator propofol	Drug: Diprivan (propofol), Astra-Zeneca continuous intravenous infusion with a dose of 3-5 mg/kg/h
2: Experimental desflurane	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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528515

Locations

Poland
Department of Cadiac Anesthesiology, Medical University of Gdańsk
Gdańsk, Poland, 80-211

Sponsors and Collaborators

Medical University of Gdansk

Investigators

Study Director:

Romuald Lango, M.D., Ph.D.

Medical University of Gdańsk, Department of Cardiac Anesthesiology

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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. 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. 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.

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.

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 History of Changes
Health Authority:	Poland: Ministry of Science and Higher Education

Keywords provided by Medical University of Gdansk:

anesthesia intravenous
propofol
anesthesia inhalation
desflurane

heart surgery
coronary artery by-pass off-pump
hemodynamic processes
anesthesia

Study placed in the following topic categories:

Arterial Occlusive Diseases
Anesthetics, Intravenous
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Anesthetics
Central Nervous System Depressants
Ischemia

Arteriosclerosis
Coronary Disease
Anesthetics, Inhalation
Desflurane
Anesthetics, General
Hypnotics and Sedatives
Propofol
Coronary Artery Disease

Additional relevant MeSH terms:

Anesthetics, Intravenous
Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Physiological Effects of Drugs
Vascular Diseases
Anesthetics
Central Nervous System Depressants
Arteriosclerosis
Pharmacologic Actions

Coronary Disease
Anesthetics, Inhalation
Desflurane
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Cardiovascular Diseases
Propofol
Central Nervous System Agents
Coronary Artery Disease

ClinicalTrials.gov processed this record on July 02, 2009