Coronary Artery DiseasePhase 4NCT05041725
The Impact of Remimazolam for Postoperative Sedation on the Left Ventricular Systolic Performance in Cardiac Surgery
A Phase 4 study testing Remimazolam Injection [Byfavo] in people with Coronary Artery Disease, run by Konkuk University Medical Center.
Trial summary
This study analyzes the impact of intraoperative Remimazolam infusion for postoperative sedation on the left ventricular global longitude strain (LV-GLS) patients undergoing cardiac surgery Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Remimazolam Injection [Byfavo]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 31 Dec 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective off-pump coronary artery bypass surgery
Who cannot join
- arrhythmia
- LV ejection fraction < 50 %
- preoperative inotropic support
About this study
Official title: The Impact of Remimazolam on the Left Ventricular Systolic Performance for Cardiac Surgery: a Speckle Tracking Analysis of the Left Ventricular Strain Using Transthoracic Echocardiography
This study analyzes the impact of intraoperative Remimazolam infusion for postoperative sedation on the left ventricular global longitude strain (LV-GLS) patients undergoing cardiac surgery
- Conditions
- Coronary Artery Disease
- Being tested
- Remimazolam Injection [Byfavo]
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam Injection [Byfavo]Drug
Also called Remimazolam infusion
Remimazolam injection and continuous infusion for postoperative sedation, 0.2 mg/kg for 1 min and continuous infusion of 1-2 mg/kg/hour
| Study group | Role | What they receive |
|---|---|---|
| remimazolam infusion | Experimental | Intraoperative remimazolam infusion for postoperative sedation Receives: Drug: Remimazolam Injection [Byfavo] |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of the left ventricular global longitudinal strain
mean values of the left ventricular global longitudinal strain after 3 minutes, 5 minutes and 10 minutes after the Remimazolam administration
Measured: 1 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Nov 2021 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041725
- Sponsor's protocol ID
- 20210000-2
- Status last verified
- Sep 2021
- First submitted
- 31 Aug 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Remimazolam on the Left Ventricular Systolic Performance for Cardiac Surgery: a Speckle Tracking Analysis of the Left Ventricular Strain Using Transthoracic Echocardiography
- ClinicalTrials.gov ID
- NCT05041725
- Acronym / sponsor ID
- 20210000-2
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 Sep 2021 (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.
This study analyzes the impact of intraoperative Remimazolam infusion for postoperative sedation on the left ventricular global longitude strain (LV-GLS) patients undergoing cardiac surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| remimazolam infusion | Experimental | Drug: Remimazolam Injection [Byfavo]Intraoperative remimazolam infusion for postoperative sedation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective off-pump coronary artery bypass surgery
Key exclusion criteria (3 listed)
- arrhythmia
- LV ejection fraction < 50 %
- preoperative inotropic support
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 |
|---|---|---|
| Remimazolam Injection [Byfavo]Also: Remimazolam infusionRemimazolam injection and continuous infusion for postoperative sedation, 0.2 mg/kg for 1 min and continuous infusion of 1-2 mg/kg/hour | Drug | remimazolam infusion |
Primary outcome
change of the left ventricular global longitudinal strain
Time frame: 1 minutes
mean values of the left ventricular global longitudinal strain after 3 minutes, 5 minutes and 10 minutes after the Remimazolam administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam Injection [Byfavo] in people with Coronary Artery Disease, run by Konkuk University Medical Center.
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 1 inclusion and 3 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 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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 the left ventricular global longitudinal strain (time frame: 1 minutes). 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 13 Sep 2021.