The Effect of Desflurane on Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting

August 7, 2014 updated by: Xin Chen, Huazhong University of Science and Technology
This study is to assess the effect of desflurane on myocardial function in patents who underwent coronary artery bypass grafting.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Desflurane, one of the third-generation inhaled anesthetics, is introduced in clinical practice in 1990s. Decades of clinical use has provided evidence for desflurane's safe and efficacious use as a general anesthetic. Compared with other volatile anesthestics, it has several characteristics: lower blood and lipid solubility, more stable in vitro and the lowest in vivo metabolism. Its particular low fat solubility properties promote rapid equilibration and rapid elimination at the end of anesthesia which reduces slow compartment accumulation and promotes predictable emergence, early extubation, and the ability to rapidly transfer patients from the operating room to the recovery unit. In addition, several investigations found that patients with desflurane anesthesia recovered their protective airway reflexes and awakened to a degree sufficient to minimize the stay in the high dependency recovery area.

A burgeoning body of investigations has shown that desflurane can directly act on myocardial and vascular functions. Desflurane has coronary vasodilative effects in in situ canine hearts which is comparable to sevoflurane does. Although it is controversial regarding to the effect of desflurane on myocardial excitation-contraction coupling and electrophysiologic behavior, a elaborated study found desflurane induced a positive inotropic effect in rat myocardium in vitro compared with isoflurane. A recent study suggested that desflurane decreased right ventricular contractility much less and maintained the right over left pressures ratio at more favorable values compared with sevoflurane. Furthermore, substantial investigations found that clinically relevant concentration desflurane preconditioning or postconditioning could protect myocardium from ischemia-reperfusion in mammalian animal models or isolated human cardiac tissues. However, it is unclear whether desflurane can provide protection for patients with coronary artery disease. Therefore, this study is designed to investigate the effect of desflurane on myocardial function in patents who underwent coronary artery bypass grafting.

Study Type

Interventional

Enrollment (Anticipated)

60

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 Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Dept. of Anesthesiolgy, Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology
        • Contact:

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

40 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. Diagnosed with CAD 2. ASAⅡ～Ⅲ

-

Exclusion Criteria:

  1. Left ventricular ejection fraction <40%
  2. Left ventricular aneurysm
  3. Acute myocardial infarction in latest two weeks, atrial fibrillation
  4. Associated vascular diseases, severe systemic diseases involving the renal and hepatic systems
  5. Respiratory disease( forced vital capacity less than 50% of predicted values )
  6. Preoperative left bundle branch block -

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Desflurane
desflurane (7%-8% end-tidal concentration), sufentanil (TCI: 2-3 ng/ml) and vecuronium (0.04mg/kg/h)
Drug: Desflurane
desflurane (7%-8% end-tidal concentration)
Other Names:
  • brand names：Baxter
  • serial numbers and code names：not available yet
Drug: sufentanil
TCI: 2-3 ng/ml during the duration of surgery, an expected average of 4 hours
Other Names:
  • brand name: Yichang Humanwell pharmaceutical co.,LTD
  • serial numbers and code names: not available yet
Active Comparator: propofol
intravenous administration of sufentanil (1μg/kg), etomidate(0.3mg/kg) and vecuronium (0.08mg/kg). The anesthesia is maintained with propofol (TCI:3.5-4.0μg/min), sufentanil (TCI: 2-3 ng/ml) and vecuronium (0.04mg/kg/h).
Drug: sufentanil
TCI: 2-3 ng/ml during the duration of surgery, an expected average of 4 hours
Other Names:
  • brand name: Yichang Humanwell pharmaceutical co.,LTD
  • serial numbers and code names: not available yet
Drug: propofol
propofol (TCI:3.5-4.0μg/min)
Other Names:
  • serial numbers and code names：not available yet
  • brand name：Diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Concentration of cTnI
Time Frame: 48 hours
at the begingineg of the surgery,immediately after surgery,4 hours after the surgery, 8 hours after the surgery, 12 hours after the surgery, 24 hours after the surgery
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuous Monitoring of ECG
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
participants will be followed for the duration of hospital stay, an expected average of 5 weeks.ECG incidents such as tachycardia, bradycardia, premature ventricualr contraction and ST segment changes will be monitored and recorded.
participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of segmental wall motion
Time Frame: Incidence of segmental wall motions will be monitored during the surgery, an expected average of 4 hours.
Incidence of segmental wall motions will be monitored during the surgery, an expected average of 4 hours.
Incidence of segmental wall motions will be monitored during the surgery, an expected average of 4 hours.

Collaborators and Investigators

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

Sponsor

Huazhong University of Science and Technology

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.

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

July 1, 2014

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

July 31, 2014

First Submitted That Met QC Criteria

August 7, 2014

First Posted (Estimate)

August 11, 2014

Study Record Updates

Last Update Posted (Estimate)

August 11, 2014

Last Update Submitted That Met QC Criteria

August 7, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140607
  • 20140627 (the ethic committee of tongji hospital)

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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