Coronary Artery Bypass Graft RedoPhase 4NCT02213718
The Effect of Desflurane on Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting
A Phase 4 study testing Desflurane, propofol and sufentanil in people with Coronary Artery Bypass Graft Redo and General Anesthetic Drug Adverse Reaction, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
This study is to assess the effect of desflurane on myocardial function in patents who underwent coronary artery bypass grafting. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Coronary Artery Bypass Graft Redo, General Anesthetic Drug Adverse Reaction
- What is being tested?
- Desflurane, propofol and sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Jun 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Diagnosed with CAD 2. ASAⅡ～Ⅲ
- -
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dept. of Anesthesiolgy, Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Ailin Luo, Doctor, 86-13507122565, alluo@tjmu.tjh.edu.cn
About this study
This study is to assess the effect of desflurane on myocardial function in patents who underwent coronary artery bypass grafting.
Read the 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.
- Being tested
- Desflurane, propofol, sufentanil
- Keywords
- Desflurane, myocardial function, Coronary Artery Bypass Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Also called brand names：Baxter, serial numbers and code names：not available yet
desflurane (7%-8% end-tidal concentration)
propofolDrug
Also called brand name：Diprivan, serial numbers and code names：not available yet
propofol (TCI:3.5-4.0μg/min)
sufentanilDrug
Also called brand name: Yichang Humanwell pharmaceutical co.,LTD, serial numbers and code names: not available yet
TCI: 2-3 ng/ml during the duration of surgery, an expected average of 4 hours
| Study group | Role | What they receive |
|---|---|---|
| Desflurane | Experimental | desflurane (7%-8% end-tidal concentration), sufentanil (TCI: 2-3 ng/ml) and vecuronium (0.04mg/kg/h) Receives: Drug: Desflurane; Drug: sufentanil |
| propofol | Active comparator | 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). Receives: Drug: propofol; Drug: sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
Secondary outcomes (1)
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.
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Graft RedoStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Chen, Huazhong University of Science and Technology
- Investigators
- Ailin Luo, Doctor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213718
- Sponsor's protocol ID
- 20140607
- Other IDs
- 20140627
- Status last verified
- Aug 2014
- First submitted
- 31 Jul 2014
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Desflurane on Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT02213718
- Acronym / sponsor ID
- 20140607
- Keywords
- Desflurane, myocardial function, Coronary Artery Bypass Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 11 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desflurane | Experimental | Drug: Desflurane, Drug: sufentanildesflurane (7%-8% end-tidal concentration), sufentanil (TCI: 2-3 ng/ml) and vecuronium (0.04mg/kg/h) |
| propofol | Active comparator | Drug: propofol, Drug: sufentanilintravenous 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). |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. Diagnosed with CAD 2. ASAⅡ～Ⅲ
- -
Key exclusion criteria (6 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesfluraneAlso: brand names：Baxter, serial numbers and code names：not available yetdesflurane (7%-8% end-tidal concentration) | Drug | Desflurane |
| propofolAlso: brand name：Diprivan, serial numbers and code names：not available yetpropofol (TCI:3.5-4.0μg/min) | Drug | propofol |
| sufentanilAlso: brand name: Yichang Humanwell pharmaceutical co.,LTD, serial numbers and code names: not available yetTCI: 2-3 ng/ml during the duration of surgery, an expected average of 4 hours | Drug | Desflurane, propofol |
Primary outcome
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
1 secondary outcome
Continuous Monitoring of ECG
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
- educationalLink provided by the sponsor.
- educationalLink provided by the sponsor.
- researchLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ailin Luo, Doctor principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desflurane, propofol and sufentanil in people with Coronary Artery Bypass Graft Redo and General Anesthetic Drug Adverse Reaction, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ailin Luo, Doctor (86-13507122565, alluo@tjmu.tjh.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Concentration of cTnI (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2014.