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CompletedNCT00528515Updated May 16, 2008

Desflurane Versus Propofol Anesthesia for Off-Pump CABG

A Phase 4 interventional study of Diprivan (propofol), Astra-Zeneca and Suprane (desflurane), Baxter in Coronary Artery Disease, sponsored by Medical University of Gdansk. Completed at 1 site in Poland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-05-16.

Sponsored by Medical University of Gdansk · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Coronary Artery Disease

Keywords

  • anesthesia intravenous
  • propofol
  • anesthesia inhalation
  • desflurane
  • heart surgery
  • coronary artery by-pass off-pump
  • hemodynamic processes
  • anesthesia
03

In context

Coronary Artery Disease

5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's enrollment of 80 is below the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Medical University of Gdansk is the lead sponsor of 130 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with coronary artery disease qualified for CABG off-pump surgery
  • Elective surgery
  • Signed informed consent

Exclusion criteria

Exclusion Criteria:

  • Left ventricle ejection fraction \< 30%
  • Serum creatinine > 2 mg/dL
  • Emergency surgery
  • Denied consent
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    1

    propofol

    Drug: Diprivan (propofol), Astra-Zeneca

  • Experimental
    2

    desflurane

    Drug: Suprane (desflurane), Baxter

Interventions

  • DrugDiprivan (propofol), Astra-Zeneca

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

    Also known as: propofol

  • DrugSuprane (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.

    Also known as: desflurane

06

What researchers measure

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)

07

Study locations

1 site
  • Department of Cadiac Anesthesiology, Medical University of Gdańsk
    Gdańsk, 80-211, Poland
08

References and documents

Publications

  • Xia Z, Luo T. Sevoflurane or desflurane anesthesia plus postoperative propofol sedation attenuates myocardial injury after coronary surgery in elderly high-risk patients. Anesthesiology. 2004 Apr;100(4):1038-9; author reply 1039-40. doi: 10.1097/00000542-200404000-00050. No abstract available. PubMed 15087655 ↗
  • Tritapepe L, Landoni G, Guarracino F, Pompei F, Crivellari M, Maselli D, De Luca M, Fochi O, D'Avolio S, Bignami E, Calabro MG, Zangrillo A. Cardiac protection by volatile anaesthetics: a multicentre randomized controlled study in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass. Eur J Anaesthesiol. 2007 Apr;24(4):323-31. doi: 10.1017/S0265021506001931. Epub 2006 Dec 8. PubMed 17156509 ↗
  • Guarracino F, Landoni G, Tritapepe L, Pompei F, Leoni A, Aletti G, Scandroglio AM, Maselli D, De Luca M, Marchetti C, Crescenzi G, Zangrillo A. Myocardial damage prevented by volatile anesthetics: a multicenter randomized controlled study. J Cardiothorac Vasc Anesth. 2006 Aug;20(4):477-83. doi: 10.1053/j.jvca.2006.05.012. PubMed 16884976 ↗
  • De Hert SG, Cromheecke S, ten Broecke PW, Mertens E, De Blier IG, Stockman BA, Rodrigus IE, Van der Linden PJ. Effects of propofol, desflurane, and sevoflurane on recovery of myocardial function after coronary surgery in elderly high-risk patients. Anesthesiology. 2003 Aug;99(2):314-23. doi: 10.1097/00000542-200308000-00013. PubMed 12883404 ↗
  • Mrozinski P, Lango R, Biedrzycka A, Kowalik MM, Pawlaczyk R, Rogowski J. Comparison of haemodynamics and myocardial injury markers under desflurane vs. propofol anaesthesia for off-pump coronary surgery. A prospective randomised trial. Anaesthesiol Intensive Ther. 2014 Jan-Mar;46(1):4-13. doi: 10.5603/AIT.2014.0002. PubMed 24643920 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00528515
Lead sponsor
Medical University of Gdansk
First posted
Sep 12, 2007
Start date
Feb 2007
Primary completion
Mar 2008
Completion
Mar 2008
Last update
May 16, 2008

Study contacts

Romuald Lango, M.D., Ph.D.
study director · Medical University of Gdańsk, Department of Cardiac Anesthesiology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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