Desflurane Versus Propofol Anesthesia for Off-Pump CABG - Tabular View

Tracking Information

First Received Date ^ICMJE

September 11, 2007

Last Updated Date

May 15, 2008

Start Date ^ICMJE

February 2007

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Markers of heart muscle injury and inflammation will be compared: troponin I, creatinine phosphokinase and its heart specific fraction, C-reactive protein. [ Time Frame: within the first 2. days after surgery. ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00528515 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evidence of clinically definite heart infarct confirmed by ECG and/or echocardiography, and heart muscle specific creatinine phosphokinase increase. [ Time Frame: To discharge from hospital (usually within 7 days) ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Desflurane Versus Propofol Anesthesia for Off-Pump CABG

Official Title ^ICMJE

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

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.

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Active Comparator: propofol
Experimental: desflurane

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Poland

Administrative Information

NCT ID ^ICMJE

NCT00528515

Responsible Party

Romuald Lango MD, PhD, Medical University of Gdańsk, Dept. of Cardiac Anesthesiology

Study ID Numbers ^ICMJE

AMG-NKEBN/364-A/2005

Study Sponsor ^ICMJE

Medical University of Gdansk

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Romuald Lango, M.D., Ph.D.

Medical University of Gdańsk, Department of Cardiac Anesthesiology

Information Provided By

Medical University of Gdansk

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP