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

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ClinicalTrials.gov Identifier: NCT02213718
Recruitment Status : Unknown
Verified August 2014 by Xin Chen, Huazhong University of Science and Technology.
Recruitment status was:  Recruiting
First Posted : August 11, 2014
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):
Xin Chen, Huazhong University of Science and Technology

Brief Summary:
This study is to assess the effect of desflurane on myocardial function in patents who underwent coronary artery bypass grafting.

Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Graft Redo General Anesthetic Drug Adverse Reaction Drug: Desflurane Drug: propofol Drug: sufentanil Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Desflurane on Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting
Study Start Date : July 2014
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


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: propofol
propofol (TCI:3.5-4.0μg/min)
Other Names:
  • brand name:Diprivan
  • 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213718


Contacts
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Contact: Ailin Luo, Doctor 86-13507122565 alluo@tjmu.tjh.edu.cn

Locations
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China, Hubei
Dept. of Anesthesiolgy, Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Ailin Luo, Doctor    86-13507122565    alluo@tjmu.tjh.edu.cn   
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
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Principal Investigator: Ailin Luo, Doctor Tongji Hospital

Additional Information:
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Responsible Party: Xin Chen, staff, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT02213718     History of Changes
Other Study ID Numbers: 20140607
20140627 ( Other Identifier: the ethic committee of tongji hospital )
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: August 11, 2014
Last Verified: August 2014
Keywords provided by Xin Chen, Huazhong University of Science and Technology:
Desflurane
myocardial function
Coronary Artery Bypass Surgery
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Sufentanil
Propofol
Desflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Inhalation