Desflurane Versus Propofol Anesthesia for Off-Pump CABG

Coronary Artery Disease Clinical Trial

Official title:

Comparison of Desflurane and Propofol Anesthesia for Off-Pump Coronary Artery Bypass Grafting Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00528515
• Other study ID #: AMG-NKEBN/364-A/2005
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2007
• Last updated: May 15, 2008
• Start date: February 2007
• Est. completion date: March 2008

Study information

• Verified date: May 2008
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical 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. hemodynamic parameters during and after the operation,

2. pulmonary gas exchange, need for mechanical ventilation and for ICU and intrahospital stay,

3. release of heart muscle injury markers in response to surgery and intraoperative ischaemia,

4. inflammatory response to the operation.

We suspect that insufflation anesthesia with desflurane may be superior to intravenous anesthesia with propofol.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Diprivan (propofol), Astra-Zeneca
continuous intravenous infusion with a dose of 3-5 mg/kg/h
• 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.

Locations

Country	Name	City	State
Poland	Department of Cadiac Anesthesiology, Medical University of Gdansk	Gdansk

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

References & Publications (4)

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. — View 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. — View Citation

Tritapepe L, Landoni G, Guarracino F, Pompei F, Crivellari M, Maselli D, De Luca M, Fochi O, D'Avolio S, Bignami E, Calabrò 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Markers of heart muscle injury and inflammation will be compared: troponin I, creatinine phosphokinase and its heart specific fraction, C-reactive protein.		within the first 2. days after surgery.	Yes
Secondary	Evidence of clinically definite heart infarct confirmed by ECG and/or echocardiography, and heart muscle specific creatinine phosphokinase increase.		To discharge from hospital (usually within 7 days)	Yes