Desflurane Versus Propofol Anesthesia for Off-Pump CABG

NCT00528515 | Completed Phase 4

• 1 other identifier: AMG-NKEBN/364-A/2005
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 1.hemodynamic parameters during and after the operation,
2. 2.pulmonary gas exchange, need for mechanical ventilation and for ICU and intrahospital stay,
3. 3.release of heart muscle injury markers in response to surgery and intraoperative ischaemia,
4. 4.inflammatory response to the operation.

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

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.

  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.

  To discharge from hospital (usually within 7 days)

Study Arms (2)

1

ACTIVE COMPARATOR

propofol

Drug: Diprivan (propofol), Astra-Zeneca

2

EXPERIMENTAL

desflurane

Drug: Suprane (desflurane), Baxter

Interventions

Diprivan (propofol), Astra-Zeneca DRUG

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

Also known as: propofol

1

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.

Also known as: desflurane

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Department of Cadiac Anesthesiology, Medical University of Gdańsk

Gdansk, 80-211, Poland

Location

Related Publications (5)

• 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.

  PMID: 15087655 BACKGROUND

• 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.

  PMID: 17156509 BACKGROUND

• 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.

  PMID: 16884976 BACKGROUND

• 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.

  PMID: 12883404 BACKGROUND

• 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.

  PMID: 24643920 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Propofol; Desflurane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ethyl Ethers; Ethers; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Romuald Lango, M.D., Ph.D.

  Medical University of Gdańsk, Department of Cardiac Anesthesiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2007
• First Posted: September 12, 2007
• Study Start: February 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: May 16, 2008

Record last verified: 2008-05

Locations

PL (1)