The Effect of Desflurane on Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting
Primary Purpose
Coronary Artery Bypass Graft Redo, General Anesthetic Drug Adverse Reaction
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Desflurane
propofol
sufentanil
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Bypass Graft Redo focused on measuring Desflurane, myocardial function, Coronary Artery Bypass Surgery
Eligibility Criteria
Inclusion Criteria:
1. Diagnosed with CAD 2. ASAⅡ~Ⅲ
-
Exclusion Criteria:
- Left ventricular ejection fraction <40%
- Left ventricular aneurysm
- Acute myocardial infarction in latest two weeks, atrial fibrillation
- Associated vascular diseases, severe systemic diseases involving the renal and hepatic systems
- Respiratory disease( forced vital capacity less than 50% of predicted values )
- Preoperative left bundle branch block -
Sites / Locations
- Dept. of Anesthesiolgy, Tongji hospital of Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Desflurane
propofol
Arm Description
desflurane (7%-8% end-tidal concentration), sufentanil (TCI: 2-3 ng/ml) and vecuronium (0.04mg/kg/h)
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).
Outcomes
Primary Outcome Measures
Serum Concentration of cTnI
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
Continuous Monitoring of ECG
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.
Full Information
NCT ID
NCT02213718
First Posted
July 31, 2014
Last Updated
August 7, 2014
Sponsor
Huazhong University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT02213718
Brief Title
The Effect of Desflurane on Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting
Official Title
The Effect of Desflurane on Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is to assess the effect of desflurane on myocardial function in patents who underwent coronary artery bypass grafting.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Bypass Graft Redo, General Anesthetic Drug Adverse Reaction
Keywords
Desflurane, myocardial function, Coronary Artery Bypass Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Desflurane
Arm Type
Experimental
Arm Description
desflurane (7%-8% end-tidal concentration), sufentanil (TCI: 2-3 ng/ml) and vecuronium (0.04mg/kg/h)
Arm Title
propofol
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Desflurane
Other Intervention Name(s)
brand names:Baxter, serial numbers and code names:not available yet
Intervention Description
desflurane (7%-8% end-tidal concentration)
Intervention Type
Drug
Intervention Name(s)
propofol
Other Intervention Name(s)
brand name:Diprivan, serial numbers and code names:not available yet
Intervention Description
propofol (TCI:3.5-4.0μg/min)
Intervention Type
Drug
Intervention Name(s)
sufentanil
Other Intervention Name(s)
brand name: Yichang Humanwell pharmaceutical co.,LTD, serial numbers and code names: not available yet
Intervention Description
TCI: 2-3 ng/ml during the duration of surgery, an expected average of 4 hours
Primary Outcome Measure Information:
Title
Serum Concentration of cTnI
Description
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
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Continuous Monitoring of ECG
Description
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.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Other Pre-specified Outcome Measures:
Title
Incidence of segmental wall motion
Description
Incidence of segmental wall motions will be monitored during the surgery, an expected average of 4 hours.
Time Frame
Incidence of segmental wall motions will be monitored during the surgery, an expected average of 4 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Diagnosed with CAD 2. ASAⅡ~Ⅲ
-
Exclusion Criteria:
Left ventricular ejection fraction <40%
Left ventricular aneurysm
Acute myocardial infarction in latest two weeks, atrial fibrillation
Associated vascular diseases, severe systemic diseases involving the renal and hepatic systems
Respiratory disease( forced vital capacity less than 50% of predicted values )
Preoperative left bundle branch block -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ailin Luo, Doctor
Phone
86-13507122565
Email
alluo@tjmu.tjh.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ailin Luo, Doctor
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Anesthesiolgy, Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ailin Luo, Doctor
Phone
86-13507122565
Email
alluo@tjmu.tjh.edu.cn
12. IPD Sharing Statement
Links:
URL
http://www.hust.edu.cn/
Description
educational
URL
http://www.tjmu.edu.cn/
Description
educational
URL
http://www.tjh.com.cn/
Description
research
Learn more about this trial
The Effect of Desflurane on Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting
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