Desflurane Versus Propofol Anesthesia for Off-Pump CABG

May 15, 2008 updated by: Medical University of Gdansk

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
within the first 2. days after surgery.

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
To discharge from hospital (usually within 7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Investigators

  • Study Director: Romuald Lango, M.D., Ph.D., Medical University of Gdańsk, Department of Cardiac Anesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

September 11, 2007

First Submitted That Met QC Criteria

September 11, 2007

First Posted (Estimate)

September 12, 2007

Study Record Updates

Last Update Posted (Estimate)

May 16, 2008

Last Update Submitted That Met QC Criteria

May 15, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMG-NKEBN/364-A/2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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