Clinical trial NCT00528515: Desflurane Versus Propofol Anesthesia for Off-Pump CABG
Official title: Comparison of Desflurane and Propofol Anesthesia for Off-Pump Coronary Artery Bypass Grafting Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: anesthesia intravenous
propofol
anesthesia inhalation
desflurane
heart surgery
coronary artery by-pass off-pump
hemodynamic processes
anesthesia
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2007-09-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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

Primary outcomes:
measure: Markers of heart muscle injury and inflammation will be compared: troponin I, creatinine phosphokinase and its heart specific fraction, C-reactive protein.
timeFrame: within the first 2. days after surgery.
Secondary outcomes:
measure: Evidence of clinically definite heart infarct confirmed by ECG and/or echocardiography, and heart muscle specific creatinine phosphokinase increase.
timeFrame: To discharge from hospital (usually within 7 days)
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Department of Cadiac Anesthesiology, Medical University of Gdańsk
Study officials:
affiliation: Medical University of Gdańsk, Department of Cardiac Anesthesiology
name: Romuald Lango, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
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. doi: 10.1097/00000542-200404000-00050. No abstract available.
citation: 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.
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. doi: 10.1053/j.jvca.2006.05.012.
citation: 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.
citation: 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.