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Completed

NCT Number: NCT00528515

Desflurane Versus Propofol Anesthesia for Off-Pump CABG

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Cadiac Anesthesiology, Medical University of Gdańsk

Gdansk, 80-211, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diprivan (propofol), Astra-Zeneca

Drug

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

Other names: propofol

Suprane (desflurane), Baxter

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 12, 2007
Registry last updated
May 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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