RemimazolamNCT06716840
Remimazolam Besylate in Sedation of Postcardioperative Patients
A study testing Remimazolam and Propofol in people with Remimazolam and Propofol, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Intensive care medicine is vital in managing patients after cardiac surgery with endotracheal intubation，in order to provide extensive monitoring to assure clinical stabilization. During this time of recovery, sedation is frequently employed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Remimazolam, Propofol, Sedation
- 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
- 120 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2025to 31 May 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years ;
- admitted to the intensive care unit after cardiac surgery with techanical ventilation；
- expected to extubation within 48hours ；
- participant has given informed consent
Who cannot join
- pregnant or lactating women
- known or suspected hypersensitivity to the study drug
- history of impaired consciousness or psychiatric illness
- severe bradycardia with a heart rate of < 50 beats per minute
- systolic blood pressure < 90 mmHg with fluid resuscitation and vasopressor maintenance
- atrioventricular block（II or III degree）, Left ventricular ejection fraction(LVEF) <30%
- participated in other clinical studies within 3 months
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, 1 recruiting
- Recruiting
First afflilated hospital of zhejiang university school of medicine
Hangzhou, Zhejiang, 310000
About this study
Official title: Remimazolam Besylate Versus Propofolfor Sedation of Postcardioperative Patients in Intensive Care Unit: a Prospective,Single-center,Randomized Non-inferior Trial
Intensive care medicine is vital in managing patients after cardiac surgery with endotracheal intubation，in order to provide extensive monitoring to assure clinical stabilization. During this time of recovery, sedation is frequently employed. However, prolonged sedation risks negative sequelae.At present,propofol, benzodiazepines, and dexmedetomidine are typical drugs used for sedation of patients in intensive care unit.Each has its own advantages and disadvantages.The investigators try to find near-ideal agents for sedation,characterized by good sedative effect,minimal adverse effects and rapid awakening facilitating earlier extubation.Remimazolam appeared to be an effective and safe sedative for short term sedation. Study participants were predicated on age (> 18 years), admission following cardiac surgery, still mechanical ventilation within 48 hours,and prior informed consent.Participants were randomized to receive remimazolam besylate or propofol in a 1:1 ratio for sedation with a target sedation depth before extubation.Finally，the investigators will compare the sedation effect and safety between the 2 groups ，to prove if remimazolam is appropriate for sedation in patients after cardiac surgery in intensive care unit.
- Conditions
- Remimazolam, Propofol, Sedation, Mechanical Ventilation, Intensive Care, Cardiac Surgery
- Being tested
- Remimazolam, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
participants in the remimazolam group received remimazolam besylate intravenously at an initial infusion rate of 0.2mg/kg/h and adjusted (maximum of 2 mg/kg/h) to maintain a Richmond Agitation-Sedation Scale(RASS) score between - 2 and 0.If the maximum dose of remimazolam was insufficient to sedate, add rescue dexmedetomidine.
PropofolDrug
participants in the propofol group received propofol intravenously at an initial infusion rate of 1 mg/kg/h and adjusted (maximum of 4 mg/kg/h) to maintain a Richmond Agitation-Sedation Scale (RASS) score between - 2 and 0.If the maximum dose of propofol was insufficient to sedate, add rescue dexmedetomidine.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam group | Experimental | Not described Receives: Drug: Remimazolam |
| propofol group | Active comparator | Not described Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of time in the target sedation range
The primary outcome was the percentage of time in the target sedation range without rescue sedation.
Measured: up to 2 days
Secondary outcomes (8)
extubation time
from stopping sedative medication to removing the endotracheal tube
Measured: up to 2 days
extubation success rate
no re-intubation within 48 hours after extubation
Measured: up to 4 days
changes in blood pressure
dynamic changes of blood pressure were recorded during sedation
Measured: up to 2 days
changes in heart rate
dynamic changes of heart rate were recorded during sedation
Measured: up to 2 days
ventilator-free days
ventilator-free days at day 7
Measured: From enrollment to 7 days
the score of confusion assessment method for the intensive care unit ( CAM-ICU)
diagnose the delirium by the CAM-ICU score，and calculate the incidence of delirium
Measured: From enrollment to the end of treatment at 28 days
stay length
length of intensive care unit stay and hospital stay
Measured: From enrollment to the end of treatment at 28 days
28-day mortality
28-day mortality after enrollment
Measured: From enrollment to the end of treatment at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start10 Feb 2025
- Primary completion30 Apr 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RemimazolamStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716840
- Sponsor's protocol ID
- 2024-143
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remimazolam Besylate Versus Propofolfor Sedation of Postcardioperative Patients in Intensive Care Unit: a Prospective,Single-center,Randomized Non-inferior Trial
- ClinicalTrials.gov ID
- NCT06716840
- Acronym / sponsor ID
- 2024-143
- Conditions
- Remimazolam, Propofol, Sedation, Mechanical Ventilation, Intensive Care, Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 4 Dec 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.
Intensive care medicine is vital in managing patients after cardiac surgery with endotracheal intubation，in order to provide extensive monitoring to assure clinical stabilization. During this time of recovery, sedation is frequently employed. However, prolonged sedation risks negative sequelae.At present,propofol, benzodiazepines, and dexmedetomidine are typical drugs used for sedation of patients in intensive care unit.Each has its own advantages and disadvantages.The investigators try to find near-ideal agents for sedation,characterized by good sedative effect,minimal adverse effects and rapid awakening facilitating earlier extubation.Remimazolam appeared to be an effective and safe sedative for short term sedation. Study participants were predicated on age (> 18 years), admission following cardiac surgery, still mechanical ventilation within 48 hours,and prior informed consent.Participants were randomized to receive remimazolam besylate or propofol in a 1:1 ratio for sedation with a target sedation depth before extubation.Finally，the investigators will compare the sedation effect and safety between the 2 groups ，to prove if remimazolam is appropriate for sedation in patients after cardiac surgery in intensive care unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam group | Experimental | Drug: Remimazolam |
| propofol group | Active comparator | Drug: Propofol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥ 18 years ;
- admitted to the intensive care unit after cardiac surgery with techanical ventilation；
- expected to extubation within 48hours ；
- participant has given informed consent
Key exclusion criteria (7 listed)
- pregnant or lactating women
- known or suspected hypersensitivity to the study drug
- history of impaired consciousness or psychiatric illness
- severe bradycardia with a heart rate of < 50 beats per minute
- systolic blood pressure < 90 mmHg with fluid resuscitation and vasopressor maintenance
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 |
|---|---|---|
| Remimazolamparticipants in the remimazolam group received remimazolam besylate intravenously at an initial infusion rate of 0.2mg/kg/h and adjusted (maximum of 2 mg/kg/h) to maintain a Richmond Agitation-Sedation Scale(RASS) score between - 2 and 0.If the maximum dose of remimazolam was insufficient to sedate, add rescue dexmedetomidine. | Drug | Remimazolam group |
| Propofolparticipants in the propofol group received propofol intravenously at an initial infusion rate of 1 mg/kg/h and adjusted (maximum of 4 mg/kg/h) to maintain a Richmond Agitation-Sedation Scale (RASS) score between - 2 and 0.If the maximum dose of propofol was insufficient to sedate, add rescue dexmedetomidine. | Drug | propofol group |
Primary outcome
percentage of time in the target sedation range
Time frame: up to 2 days
The primary outcome was the percentage of time in the target sedation range without rescue sedation.
8 secondary outcomes
extubation time
Time frame: up to 2 days
extubation success rate
Time frame: up to 4 days
changes in blood pressure
Time frame: up to 2 days
changes in heart rate
Time frame: up to 2 days
ventilator-free days
Time frame: From enrollment to 7 days
the score of confusion assessment method for the intensive care unit ( CAM-ICU)
Time frame: From enrollment to the end of treatment at 28 days
stay length
Time frame: From enrollment to the end of treatment at 28 days
28-day mortality
Time frame: From enrollment to the end of treatment at 28 days
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 18 Feb 2025.
- Individual participant dataSharing planned: Yes
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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.
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 Remimazolam and Propofol, run by First Affiliated Hospital of Zhejiang 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 7 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: looking for participants now, as of the sponsor's last update on 18 Feb 2025. 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 Yu Wenqiao PhD (+86-18868787588, yuwenqiao1980@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of time in the target sedation range (time frame: up to 2 days). 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 18 Feb 2025.