Desflurane Versus Propofol Anesthesia for Off-Pump CABG

NCT ID: NCT00528515

Last Updated: 2008-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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1

propofol

Group Type ACTIVE_COMPARATOR

Diprivan (propofol), Astra-Zeneca

Intervention Type DRUG

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

2

desflurane

Group Type EXPERIMENTAL

Suprane (desflurane), Baxter

Intervention Type 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.

Interventions

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Diprivan (propofol), Astra-Zeneca

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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propofol desflurane

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Gdansk

OTHER

Sponsor Role lead

Responsible Party

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Medical University of Gdańsk, Dept. of Cardiac Anesthesiology

Principal Investigators

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

Role: STUDY_DIRECTOR

Medical University of Gdańsk, Department of Cardiac Anesthesiology

Locations

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Department of Cadiac Anesthesiology, Medical University of Gdańsk

Gdansk, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type BACKGROUND
PMID: 15087655 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17156509 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16884976 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12883404 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24643920 (View on PubMed)

Related Links

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Other Identifiers

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AMG-NKEBN/364-A/2005

Identifier Type: -

Identifier Source: org_study_id