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

General Anesthetic Drug Adverse Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02213718
• Other study ID #: 20140607
• Secondary ID: 20140627
• Status: Recruiting
• Phase: Phase 4
• First received: July 31, 2014
• Last updated: August 7, 2014
• Start date: July 2014
• Est. completion date: June 2017

Study information

• Verified date: August 2014
• Source: Huazhong University of Science and Technology
• Contact: Ailin Luo, Doctor
• Phone: 86-13507122565
• Email: alluo[@]tjmu.tjh.edu.cn
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Diagnosed with CAD 2. ASA?~?

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Bypass Graft Redo
• Drug-Related Side Effects and Adverse Reactions
• General Anesthetic Drug Adverse Reaction

Intervention

Drug:
• Desflurane
desflurane (7%-8% end-tidal concentration)
• propofol
propofol (TCI:3.5-4.0µg/min)
• sufentanil
TCI: 2-3 ng/ml during the duration of surgery, an expected average of 4 hours

Locations

Country	Name	City	State
China	Dept. of Anesthesiolgy, Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of segmental wall motion	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.	Yes
Primary	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	48 hours	Yes
Secondary	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.	participants will be followed for the duration of hospital stay, an expected average of 5 weeks	Yes

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