Desflurane Versus Propofol Anesthesia for Off-Pump CABG

Sponsor

Medical University of Gdansk (Other)

Overall Status

Completed

CT.gov ID

NCT00528515

Collaborator

(none)

Enrollment

Location

Arms

12.9

Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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:

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 or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Diprivan (propofol), Astra-Zeneca Drug: Suprane (desflurane), Baxter	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Mar 1, 2008

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: 1

propofol

Drug: Diprivan (propofol), Astra-Zeneca

continuous intravenous infusion with a dose of 3-5 mg/kg/h

Other Names:

propofol

Experimental: 2

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.

Other Names:

desflurane

Outcome Measures

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. [within the first 2. days after surgery.]

Secondary Outcome Measures

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)]