Light SedationPhase 3LOSREBNCT05555667
Long-term Sedation With Remimazolam Besylate in Critically Ill Patients
A Phase 3 study testing Remimazolam besylate and Propofol in people with Light Sedation and Mechanical Ventilation, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
A randomized non-inferior trial comparing remimazolam besylate with propofol for long-term sedation during invasive mechanical ventilation in critically ill patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Light Sedation, Mechanical Ventilation
- What is being tested?
- Remimazolam besylate and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 728 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2023to 1 Dec 2025
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 80 years;
- Intubated and mechanically ventilated ≤96 hours before enrollment；
- Expected to require continuous invasive ventilation and sedation ≥24 hours;
- Requirement for light to moderate sedation (a RASS score of -3 to 0)
Who cannot join
- Body mass index (BMI) <18 or >30 kg/m2;
- Allergy or unsuitabilty to any composition of study drugs or remifentanil;
- Living expectancy less than 48 hours；
- Possible surgey in the operating room in 24 hours；
- Myasthenia gravis;
- Serious hepatic dysfunction (CTP 10-15);
Show all 16Show fewer
- Chronic kidney disease with glomerular filtration rate (GFR) < 29 ml/min/1.73m2;
- Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors;
- Acute severe neurological disorder and any other condition interfering with RASS assessment;
- Pregnancy or lactation;
- Unstable angina or acute myocardial infarction;
- Left ventricular ejection fraction less than 30%;
- Heart rate less than 50 beats/min;
- Grade 2 , second degree or third degree atrioventricular block in the absence of a pacemaker;
- Abuse of controlled substances or alcohol;
- Other conditions deemed unsuitable to be included;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Xiaobo Yang
About this study
Official title: Long-term Sedation With Remimazolam Besylate Versus Propofol in Critically Ill Patients During Invasive Mechanical Ventilation: a Randomized Non-inferior Trial
A randomized non-inferior trial comparing remimazolam besylate with propofol for long-term sedation during invasive mechanical ventilation in critically ill patients
- Conditions
- Light Sedation, Mechanical Ventilation
- Being tested
- Remimazolam besylate, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam besylateDrug
Sedation drug
PropofolDrug
Propofol. Sedation drug
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam besylate | Experimental | Remimazolam besylate at an initial infusion rate of 0.15 mg/kg/h and adjusted (maximum of 0.3 mg/kg/h) to maintain a RASS score between - 3 and 0 Receives: Drug: Remimazolam besylate |
| Propofol | Active comparator | Propofol intravenously at an initial infusion rate of 2.0 mg/kg/h and adjusted (maximum of 4.0 mg/kg/h) to maintain a RASS score between - 3 and 0 Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of time in the target sedation range without rescue sedation
The percentage of time in the target sedation range without rescue sedation
Measured: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Secondary outcomes (22)
Invasive ventilator free time
Hours of time free from invasive ventilator
Measured: From start of study to 7 days
Successful extubation rate
Extubation of endotracheal tube for the first time in 7 days without reintubation or switching to tracheostomy within the following 48 hours
Measured: From start of study to 7 days
Length of ICU stay
Length of ICU stay
Measured: From start of study to 28 days
Mortality
Mortality
Measured: From start of study to 28 days
Length of hospitalization
Length of hospitalization
Measured: From start of study to 28 days
weaning time
weaning time in minutes between continuous discontinuation of the study drug and extubation in patients with successful extubation
Measured: From start of study to 7 days
Rate of hypotension
Systolic blood pressure less than 80 mmHg or diastolic blood pressure less than 50 mmHg for 5 minutes or treated with vasopressors
Measured: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of hypertension
systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mmHg for 5 minutes or treated with vasodilators
Measured: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of bradycardia
heart rate less than 50 bpm for 5 minutes or treated with medication to increase heart rate
Measured: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of tachycardia
heart rate greater than 120 bpm for 5 minutes or treated with medication to decrease heart rate
Measured: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of unplanned extubation of endotracheal tube
unplanned extubation of endotracheal tube
Measured: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of shock
New-onset shock
Measured: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of hospital-acquired pneumonia
hospital-acquired pneumonia
Measured: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of myocardial infarction
myocardial infarction
Measured: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of cerebral ischemic stroke
cerebral ischemic stroke
Measured: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of cerebral hemorrhagic stroke
Rate of cerebral hemorrhagic stroke
Measured: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of pulmonary embolism
pulmonary embolism
Measured: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of upper digestive tract ulcer confirmed endoscopically
upper digestive tract ulcer confirmed endoscopically
Measured: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of more than 500 milliliters of bloody stool
more than 500 milliliters of bloody stool
Measured: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of delirium
delirium
Measured: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
delta SOFA
defined as the difference between SOFA when each patient stops receiving the study drug and SOFA at inclusion
Measured: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of withdraw from the trial because of intolerance, severe adverse events or other safety concerns
rate of withdraw from the trial because of intolerance, severe adverse events or other safety concerns
Measured: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start16 May 2023
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Light SedationStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 728 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaobo Yang, MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555667
- Sponsor's protocol ID
- WHUICU202209
- Acronym
- LOSREB
- Status last verified
- Sep 2022
- First submitted
- 22 Sep 2022
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yang X, Tang Y, Du R, Yu Y, Xu J, Zhang J, Liu H, Zou X, Ren L, Yuan S, Shang Y. Long-term sedation with remimazolam besylate versus propofol in critically ill patients during invasive mechanical ventilation: a study protocol for a multicenter randomized non-inferior trial. Front Pharmacol. 2023 Jul 28;14:1139872. doi: 10.3389/fphar.2023.1139872. eCollection 2023.
PubMed 37576823
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Sedation With Remimazolam Besylate Versus Propofol in Critically Ill Patients During Invasive Mechanical Ventilation: a Randomized Non-inferior Trial
- ClinicalTrials.gov ID
- NCT05555667
- Acronym / sponsor ID
- LOSREB / WHUICU202209
- Conditions
- Light Sedation, Mechanical Ventilation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 728 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 16 May 2023 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 27 Sep 2022 (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.
A randomized non-inferior trial comparing remimazolam besylate with propofol for long-term sedation during invasive mechanical ventilation in critically ill patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam besylate | Experimental | Drug: Remimazolam besylateRemimazolam besylate at an initial infusion rate of 0.15 mg/kg/h and adjusted (maximum of 0.3 mg/kg/h) to maintain a RASS score between - 3 and 0 |
| Propofol | Active comparator | Drug: PropofolPropofol intravenously at an initial infusion rate of 2.0 mg/kg/h and adjusted (maximum of 4.0 mg/kg/h) to maintain a RASS score between - 3 and 0 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 and ≤ 80 years;
- Intubated and mechanically ventilated ≤96 hours before enrollment；
- Expected to require continuous invasive ventilation and sedation ≥24 hours;
- Requirement for light to moderate sedation (a RASS score of -3 to 0)
Key exclusion criteria (16 listed)
- Body mass index (BMI) <18 or >30 kg/m2;
- Allergy or unsuitabilty to any composition of study drugs or remifentanil;
- Living expectancy less than 48 hours；
- Possible surgey in the operating room in 24 hours；
- Myasthenia gravis;
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 besylateSedation drug | Drug | Remimazolam besylate |
| PropofolPropofol. Sedation drug | Drug | Propofol |
Primary outcome
The percentage of time in the target sedation range without rescue sedation
Time frame: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
The percentage of time in the target sedation range without rescue sedation
22 secondary outcomes
Invasive ventilator free time
Time frame: From start of study to 7 days
Successful extubation rate
Time frame: From start of study to 7 days
Length of ICU stay
Time frame: From start of study to 28 days
Mortality
Time frame: From start of study to 28 days
Length of hospitalization
Time frame: From start of study to 28 days
weaning time
Time frame: From start of study to 7 days
Rate of hypotension
Time frame: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of hypertension
Time frame: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of bradycardia
Time frame: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of tachycardia
Time frame: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of unplanned extubation of endotracheal tube
Time frame: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of shock
Time frame: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of hospital-acquired pneumonia
Time frame: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of myocardial infarction
Time frame: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of cerebral ischemic stroke
Time frame: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of cerebral hemorrhagic stroke
Time frame: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of pulmonary embolism
Time frame: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of upper digestive tract ulcer confirmed endoscopically
Time frame: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of more than 500 milliliters of bloody stool
Time frame: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of delirium
Time frame: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
delta SOFA
Time frame: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Rate of withdraw from the trial because of intolerance, severe adverse events or other safety concerns
Time frame: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Derived from this study: PubMed 37576823Yang X, Tang Y, Du R, Yu Y, Xu J, Zhang J, Liu H, Zou X, Ren L, Yuan S, Shang Y. Long-term sedation with remimazolam besylate versus propofol in critically ill patients during invasive mechanical ventilation: a study protocol for a multicenter randomized non-inferior trial. Front Pharmacol. 2023 Jul 28;14:1139872. doi: 10.3389/fphar.2023.1139872. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remimazolam besylate and Propofol in people with Light Sedation and Mechanical Ventilation, run by Union Hospital, Tongji Medical College, 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 4 inclusion and 16 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 26 May 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 You Shang, MD (008602785726114 ext. 61606, you_shanghust@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of time in the target sedation range without rescue sedation (time frame: 7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05555667, which also lists 1 linked publication.
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 26 May 2023.