Desflurane Versus Propofol Anesthesia for Off-Pump CABG

Condition(s) targeted: Coronary Artery Disease

Intervention: Diprivan (propofol), Astra-Zeneca (Drug); Suprane (desflurane), Baxter (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Medical University of Gdansk

Official(s) and/or principal investigator(s):
Romuald Lango, M.D., Ph.D., Study Director, Affiliation: Medical University of Gdańsk, Department of Cardiac Anesthesiology

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.

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

Study design: Supportive Care, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Markers of heart muscle injury and inflammation will be compared: troponin I, creatinine phosphokinase and its heart specific fraction, C-reactive protein.

Secondary outcome: Evidence of clinically definite heart infarct confirmed by ECG and/or echocardiography, and heart muscle specific creatinine phosphokinase increase.

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

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

Related 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.

Starting date: February 2007
Ending date: March 2008
Last updated: May 15, 2008