Coronary Artery DiseaseNCT06496165
Remimazolam Besylate and Propofol Sedation on Hemodynamic for Coronary Artery Bypass Graft Patients
A study testing Remimazolam and Propofol in people with Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
In the immediate postoperative period following cardiac surgery, many patients require short-term sedation until cardiovascular and respiratory stability has been achieved and weaning from artificial ventilation can be started. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Remimazolam and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the informed consent form voluntarily and follow the plan requirements;
- age over 60 years old;
- post coronary artery bypass surgery;
- anticipated mechanical ventilation duration >8 hours
- admission to the cardiac surgery intensive care unit of Zhongshan hospital, Fudan University
Who cannot join
- delirium before surgery
- severe cognitive dysfunction before surgery
- patients with over degree II A-V block or consistent bradycardia
- patients who are still not awake 12 hours after surgery
- patients who are agitated or cannot follow command
- patients with mechanical circulatory support (ECMO, IABP)
Show all 9Show fewer
- patients who are allergy to propofol or remimazolam
- BMI≥30kg/m2
- patients with much drainage, the surgery ask for blood pressure control or reopen the chest
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital Fudan university
Shanghai, Shanghai Municipality, 200032
Guo-wei Tu, 02164041990, tu.guowei@zs-hospital.sh.cn
Guang-wei Hao, 02164041990, hao.guangwei@zs-hospital.sh.cn
About this study
Official title: Comparison of the Effects of Remimazolam Besylate and Propofol Sedation on Hemodynamic for Coronary Artery Bypass Graft Patients：a Prospective, Single Blinded, Randomized Controlled Trial
In the immediate postoperative period following cardiac surgery, many patients require short-term sedation until cardiovascular and respiratory stability has been achieved and weaning from artificial ventilation can be started. For these patients, current guideline recommended propofol over benzodiazepine, mainly because of the short elimination half life of propofol. However, hypotension, a very common side effect of propofol, may impose restrictions on its use in some cardiac surgery patients. Remimazolam besylate is a novel, ultra-short-acting benzodiazepine that undergoes organ-independent metabolism by tissue esterases into an inactive metabolite. In other words, remimazolam has both the property of quick offset of effect like propofol and the stable hemodynamic effect like midazolam, making it favorable for use as a sedative in cardiac surgery patients. The aim of this study is to evaluate the hemodynamic effect of remimazolam besylate versus propofol in patients undergoing cardiac surgery.
- Conditions
- Coronary Artery Disease
- Being tested
- Remimazolam, Propofol
- 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.
RemimazolamDrug
Intravenous pump injection. The loading dose will be 0.1mg/kg, the maintenance dose will be 0.1-0.5mg/kg/h, with the target RASS be -2-0
PropofolDrug
Intravenous pump injection. The loading dose will be 0.5mg/kg, the maintenance dose will be 1-4mg/kg/h, with the target RASS be -2-0
| Study group | Role | What they receive |
|---|---|---|
| remimazolam | Experimental | Not described Receives: Drug: Remimazolam |
| propofol | Active comparator | Not described Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of hypotension during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery
Measured: Within 8 hours of study drug used
Secondary outcomes (1)
RASS score during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery
Measured: Within 8 hours of study drug used
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start15 Jul 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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.
- More trials run by Shanghai Zhongshan HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhe Luo, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496165
- Sponsor's protocol ID
- REMAP
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Remimazolam Besylate and Propofol Sedation on Hemodynamic for Coronary Artery Bypass Graft Patients：a Prospective, Single Blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06496165
- Acronym / sponsor ID
- REMAP
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Jul 2024 (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.
In the immediate postoperative period following cardiac surgery, many patients require short-term sedation until cardiovascular and respiratory stability has been achieved and weaning from artificial ventilation can be started. For these patients, current guideline recommended propofol over benzodiazepine, mainly because of the short elimination half life of propofol. However, hypotension, a very common side effect of propofol, may impose restrictions on its use in some cardiac surgery patients. Remimazolam besylate is a novel, ultra-short-acting benzodiazepine that undergoes organ-independent metabolism by tissue esterases into an inactive metabolite. In other words, remimazolam has both the property of quick offset of effect like propofol and the stable hemodynamic effect like midazolam, making it favorable for use as a sedative in cardiac surgery patients. The aim of this study is to evaluate the hemodynamic effect of remimazolam besylate versus propofol in patients undergoing cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remimazolam | Experimental | Drug: Remimazolam |
| propofol | Active comparator | Drug: Propofol |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sign the informed consent form voluntarily and follow the plan requirements;
- age over 60 years old;
- post coronary artery bypass surgery;
- anticipated mechanical ventilation duration >8 hours
- admission to the cardiac surgery intensive care unit of Zhongshan hospital, Fudan University
Key exclusion criteria (9 listed)
- delirium before surgery
- severe cognitive dysfunction before surgery
- patients with over degree II A-V block or consistent bradycardia
- patients who are still not awake 12 hours after surgery
- patients who are agitated or cannot follow command
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 |
|---|---|---|
| RemimazolamIntravenous pump injection. The loading dose will be 0.1mg/kg, the maintenance dose will be 0.1-0.5mg/kg/h, with the target RASS be -2-0 | Drug | remimazolam |
| PropofolIntravenous pump injection. The loading dose will be 0.5mg/kg, the maintenance dose will be 1-4mg/kg/h, with the target RASS be -2-0 | Drug | propofol |
Primary outcome
rate of hypotension during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery
Time frame: Within 8 hours of study drug used
1 secondary outcome
RASS score during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery
Time frame: Within 8 hours of study drug used
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
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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.
Zhe Luo principal investigator
Fudan 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 Remimazolam and Propofol in people with Coronary Artery Disease, run by Shanghai Zhongshan Hospital 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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 11 Jul 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guo-wei Tu (13501996995, tu.guowei@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of hypotension during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery (time frame: Within 8 hours of study drug used). 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 Jul 2024.