Coronary Artery Bypass, Off-PumpNCT03163693
The Effects of Dexmedetomidine on cTnI and GP-BB in Patients Undergoing OPCABG
A study testing dexmedetomidine and normal saline in people with Coronary Artery Bypass, Off-Pump, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
The purpose of this study is to observe the impact of dexmedetomidine on Cardiac Troponin I and Glycogen Phosphorylase Isoenzyme BB in patients undergoing off-pump coronary artery bypass Grafting. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Coronary Artery Bypass, Off-Pump
- What is being tested?
- dexmedetomidine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to May 2017
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing off - pump coronary artery bypass grafting
- ASA physical status III-IV
- Aged 40-70 years
- NYHA physical status II-III
Who cannot join
- Bradycardia
- Atrioventricular block
- Echocardiography suggested:LVEF <40%, LVED>65mm
- Allergic to the drugs
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
About this study
Official title: The Effects of Dexmedetomidine on Cardiac Troponin I and Glycogen Phosphorylase Isoenzyme BB in Patients Undergoing Off-pump Coronary Artery Bypass Grafting
The purpose of this study is to observe the impact of dexmedetomidine on Cardiac Troponin I and Glycogen Phosphorylase Isoenzyme BB in patients undergoing off-pump coronary artery bypass Grafting.
Read the detailed description
Dexmedetomidine is a highly selective α2-adrenoceptor agonist used as a sedative or adjuvant anesthetic drug in clinical settings.From clinical observation, dexmedetomidine has been revealed to reduce the incidence of cardiovascular adverse events in patients with heart diseases during non-cardiac surgeries.Therefore, the aim of this sudy is to observe the impact of dexmedetomidine on Cardiac Troponin I and Glycogen Phosphorylase Isoenzyme BB in patients during cardiac surgeries.
- Conditions
- Coronary Artery Bypass, Off-Pump
- Being tested
- dexmedetomidine, normal saline
- Keywords
- Dexmedetomidine, Cardiac Troponin I, Glycogen Phosphorylase Isoenzyme BB
- Medical subject headings
- Cardiomyopathy, Dilated, 1FF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
Also called Dex
receive dexmedetomidine 0.5 μg/kg
normal salineOther
receive equal volume of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Group dexmedetomidine | Experimental | 20 eligible patients are received 0.5ug/kg dexmedetomidine intravenously 15 minutes before surgery Receives: Drug: dexmedetomidine |
| Group control | Placebo comparator | 20 eligible patients are received equal volumes normal saline intravenously 15 minutes before surgery Receives: Other: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of cardiac troponin I at preoperative, postoperative，and 24 hours after surgery.
Blood samples were sampled at preoperative, postoperative，and 24 hours after surgery for the cTnI，which were analyzed by using enzyme linked immunosorbent assay (ELISA).
Measured: At preoperative, postoperative，and 24 hours after surgery.
Change of Glycogen Phosphorylase Isoenzyme BB at preoperative, postoperative，and 24 hours after surgery.
Blood samples were sampled at preoperative, postoperative，and 24 hours after surgery for the GP-BB，which were analyzed by using enzyme linked immunosorbent assay (ELISA).
Measured: At preoperative, postoperative，and 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study startFeb 2016
- Primary completionMay 2017
- Study completionMay 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, Off-PumpStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhu Di, Principal investigator, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163693
- Sponsor's protocol ID
- 2015-NW-028
- Status last verified
- May 2017
- First submitted
- 15 May 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: safety
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dexmedetomidine on Cardiac Troponin I and Glycogen Phosphorylase Isoenzyme BB in Patients Undergoing Off-pump Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT03163693
- Acronym / sponsor ID
- 2015-NW-028
- Conditions
- Coronary Artery Bypass, Off-Pump
- Keywords
- Dexmedetomidine, Cardiac Troponin I, Glycogen Phosphorylase Isoenzyme BB
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (estimated)
- First posted
- 23 May 2017 (actual)
- 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.
The purpose of this study is to observe the impact of dexmedetomidine on Cardiac Troponin I and Glycogen Phosphorylase Isoenzyme BB in patients undergoing off-pump coronary artery bypass Grafting.
Detailed description
Dexmedetomidine is a highly selective α2-adrenoceptor agonist used as a sedative or adjuvant anesthetic drug in clinical settings.From clinical observation, dexmedetomidine has been revealed to reduce the incidence of cardiovascular adverse events in patients with heart diseases during non-cardiac surgeries.Therefore, the aim of this sudy is to observe the impact of dexmedetomidine on Cardiac Troponin I and Glycogen Phosphorylase Isoenzyme BB in patients during cardiac surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group dexmedetomidine | Experimental | Drug: dexmedetomidine20 eligible patients are received 0.5ug/kg dexmedetomidine intravenously 15 minutes before surgery |
| Group control | Placebo comparator | Other: normal saline20 eligible patients are received equal volumes normal saline intravenously 15 minutes before surgery |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing off - pump coronary artery bypass grafting
- ASA physical status III-IV
- Aged 40-70 years
- NYHA physical status II-III
Key exclusion criteria (4 listed)
- Bradycardia
- Atrioventricular block
- Echocardiography suggested:LVEF <40%, LVED>65mm
- Allergic to the drugs
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 |
|---|---|---|
| dexmedetomidineAlso: Dexreceive dexmedetomidine 0.5 μg/kg | Drug | Group dexmedetomidine |
| normal salinereceive equal volume of normal saline | Other | Group control |
Primary outcome
Change of cardiac troponin I at preoperative, postoperative，and 24 hours after surgery.
Time frame: At preoperative, postoperative，and 24 hours after surgery.
Blood samples were sampled at preoperative, postoperative，and 24 hours after surgery for the cTnI，which were analyzed by using enzyme linked immunosorbent assay (ELISA).
Change of Glycogen Phosphorylase Isoenzyme BB at preoperative, postoperative，and 24 hours after surgery.
Time frame: At preoperative, postoperative，and 24 hours after surgery.
Blood samples were sampled at preoperative, postoperative，and 24 hours after surgery for the GP-BB，which were analyzed by using enzyme linked immunosorbent assay (ELISA).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Individual participant dataSharing planned: No. safety
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Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
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Multivessel Minimally Invasive Coronary Bypass Grafting as HYBRID Revascularization Versus Conventional Off-pump Coronary Artery Bypass Grafting
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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.
Zhu Di principal investigator
General Hospital of Ningxia Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexmedetomidine and normal saline in people with Coronary Artery Bypass, Off-Pump, run by General Hospital of Ningxia Medical University 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 4 inclusion and 4 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 23 May 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of cardiac troponin I at preoperative, postoperative，and 24 hours after surgery. (time frame: At preoperative, postoperative，and 24 hours after surgery.). The study lists 2 primary outcomes in all. 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 23 May 2017.