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

NCT ID: NCT02213718

Last Updated: 2014-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-06-30

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.

Conditions

Coronary Artery Bypass Graft Redo; General Anesthetic Drug Adverse Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Desflurane

desflurane (7%-8% end-tidal concentration), sufentanil (TCI: 2-3 ng/ml) and vecuronium (0.04mg/kg/h)

Group Type: EXPERIMENTAL

Desflurane

Intervention Type: DRUG

desflurane (7%-8% end-tidal concentration)

sufentanil

Intervention Type: DRUG

TCI: 2-3 ng/ml during the duration of surgery, an expected average of 4 hours

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).

Group Type: ACTIVE_COMPARATOR

propofol

Intervention Type: DRUG

propofol (TCI:3.5-4.0μg/min)

sufentanil

Intervention Type: DRUG

TCI: 2-3 ng/ml during the duration of surgery, an expected average of 4 hours

Interventions

Desflurane

desflurane (7%-8% end-tidal concentration)

Intervention Type: DRUG

propofol

propofol (TCI:3.5-4.0μg/min)

Intervention Type: DRUG

sufentanil

TCI: 2-3 ng/ml during the duration of surgery, an expected average of 4 hours

Intervention Type: DRUG

Other Intervention Names

brand names：Baxter; serial numbers and code names：not available yet; brand name：Diprivan; serial numbers and code names：not available yet; brand name: Yichang Humanwell pharmaceutical co.,LTD; serial numbers and code names: not available yet

Eligibility 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 -

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Xin Chen

staff

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ailin Luo, Doctor

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

Dept. of Anesthesiolgy, Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ailin Luo, Doctor

Role: CONTACT

alluo@tjmu.tjh.edu.cn

86-13507122565

Facility Contacts

Ailin Luo, Doctor

Role: primary

alluo@tjmu.tjh.edu.cn

86-13507122565

Related Links

http://www.hust.edu.cn/

educational

http://www.tjmu.edu.cn/

educational

http://www.tjh.com.cn/

research

Other Identifiers

20140627

Identifier Type: OTHER

Identifier Source: secondary_id

20140607

Identifier Type: -

Identifier Source: org_study_id