Desflurane Versus Propofol Anesthesia for Off-Pump CABG

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Diprivan (propofol), Astra-Zeneca; Drug: Suprane (desflurane), Baxter

• Registration Number: NCT00528515
• Lead Sponsor: Medical University of Gdansk

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.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-09-11
• Study First Submitted QC: 2007-09-11
• Study First Posted: 2007-09-12
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-15
• Last Update Posted: 2008-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Diprivan (propofol), Astra-Zeneca	propofol
2	Suprane (desflurane), Baxter	desflurane

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Department of Cadiac Anesthesiology, Medical University of Gdańsk; 🇵🇱 Gdańsk, Poland