SedativePhase 3NCT05782894
Step 2 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients
A Phase 3 study testing Remimazolam besylate, Propofol and Remifentanil in people with Sedative 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 short-term sedation during invasive mechanical ventilation in intensive care units Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sedative, Mechanical Ventilation
- What is being tested?
- Remimazolam besylate, Propofol and Remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2023to 25 Nov 2023
- 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
- Body mass index (BMI) ≥18 and ≤ 30 kg/m2
- Being Intubated and mechanically ventilated ≤48 hours before enrollment and expected to be on ventilator for at least 6 hours
- Requirement for light to moderate sedation (a Richmond agitation-sedation scale score of -2 to 1)
Who cannot join
- Refusal to be included
- Allergy or unsuitability to any composition of study drugs or remifentanil
- Living expectancy less than 48 hours
- Myasthenia gravis
- Status asthmaticus
- Abdominal compartment syndrome
Show all 16Show fewer
- Serious hepatic dysfunction (CTP 10-15);
- Chronic kidney disease with glomerular filtration rate (GFR) < 29 ml/min/1.73m2
- Mean blood pressure less than 65 mm Hg or the need of a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain Mean blood pressure ≥ 65 mm Hg
- Possible requirement for surgery or bedside tracheostomy in 24 hours
- Possible requirement for renal replacement therapy in 24 hours
- Acute severe neurological disorder and any other condition interfering with sedation assessment
- Abuse of controlled substances or alcohol
- Pregnancy or lactation
- Inclusion in another interventional trial in the past 30 days
- Other conditions deemed unsuitable to be included
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Injection for Sedation in ICU Patients
A randomized non-inferior trial comparing remimazolam besylate with propofol for short-term sedation during invasive mechanical ventilation in intensive care units
- Conditions
- Sedative, Mechanical Ventilation
- Being tested
- Remimazolam besylate, Propofol, Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam besylateDrug
0~2.0mg/kg/h
PropofolDrug
0.3~4.0mg/kg/h
RemifentanilDrug
1.5~12μg/kg/h
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam besylate | Experimental | Remimazolam besylate Receives: Drug: Remimazolam besylate; Drug: Remifentanil |
| Propofol | Active comparator | Propofol Receives: Drug: Propofol; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful sedation
70% of time in the target sedation range in participants without rescue sedation
Measured: 24 hours
Secondary outcomes (4)
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: 24 hours
Number of patients needing rescue sedation
Whether participants need sedative drugs other than the study drug to re maintain targeted sedation level
Measured: 24 hours
Number of patients needing repeated boluses of the study drug
Whether participants need repeated boluses of the study durg other than the loading dose to maintain targeted sedation level
Measured: 24 hours
The amount of remifentanil in ug/kg/h
The amount of remifentanil in ug/kg/h used in each patient in both groups
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start28 Feb 2023
- Primary completion25 Nov 2023
- Study completion25 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SedativeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Yichang Humanwell Pharmaceutical Co., Ltd., China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782894
- Sponsor's protocol ID
- WHUICU202208
- Status last verified
- Dec 2023
- First submitted
- 18 Feb 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang X, Pan J, Gong X, Lv A, Liang F, Liu J, Li D, Fu S, Pan A, Yu L, Zhang L, Chen T, Zhan L, Qin B, Lin F, Xiong X, Zhu Y, He Z, Sun R, Sun T, Qian S, Wen D, Zou X, Qi H, Shu H, Song L, Wang C, Shang Y. Short-term light sedation with remimazolam besylate versus propofol in the ICU (SHOSREB): a multicentre, randomized, single-blind, controlled trial. Intensive Care Med. 2026 May;52(5):1001-1011. doi: 10.1007/s00134-026-08381-x. Epub 2026 Mar 31.
PubMed 41915173Tang Y, Shu H, Ren L, Li R, Zou X, Qi H, Ouyang Y, Wu Y, Xu J, Fang X, Yang X, Shang Y. Remimazolam Besylate Versus Propofol for Short-Term Sedation in Critically Ill Patients Receiving Mechanical Ventilation: Protocol for a Multicenter Randomized Non-inferior Trial. Adv Ther. 2025 Aug;42(8):4081-4088. doi: 10.1007/s12325-025-03268-7. Epub 2025 Jun 10.
PubMed 40493335
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Injection for Sedation in ICU Patients
- ClinicalTrials.gov ID
- NCT05782894
- Acronym / sponsor ID
- WHUICU202208
- Conditions
- Sedative, Mechanical Ventilation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Yichang Humanwell Pharmaceutical Co., Ltd., China
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 25 Nov 2023 (actual)
- Study completion
- 25 Nov 2023 (actual)
- First posted
- 24 Mar 2023 (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 short-term sedation during invasive mechanical ventilation in intensive care units
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 besylate, Drug: RemifentanilRemimazolam besylate |
| Propofol | Active comparator | Drug: Propofol, Drug: RemifentanilPropofol |
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
- Body mass index (BMI) ≥18 and ≤ 30 kg/m2
- Being Intubated and mechanically ventilated ≤48 hours before enrollment and expected to be on ventilator for at least 6 hours
- Requirement for light to moderate sedation (a Richmond agitation-sedation scale score of -2 to 1)
Key exclusion criteria (16 listed)
- Refusal to be included
- Allergy or unsuitability to any composition of study drugs or remifentanil
- Living expectancy less than 48 hours
- Myasthenia gravis
- Status asthmaticus
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 besylate0~2.0mg/kg/h | Drug | Remimazolam besylate |
| Propofol0.3~4.0mg/kg/h | Drug | Propofol |
| Remifentanil1.5~12μg/kg/h | Drug | Propofol, Remimazolam besylate |
Primary outcome
Successful sedation
Time frame: 24 hours
70% of time in the target sedation range in participants without rescue sedation
4 secondary outcomes
The percentage of time in the target sedation range without rescue sedation
Time frame: 24 hours
Number of patients needing rescue sedation
Time frame: 24 hours
Number of patients needing repeated boluses of the study drug
Time frame: 24 hours
The amount of remifentanil in ug/kg/h
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Derived from this study: PubMed 41915173Yang X, Pan J, Gong X, Lv A, Liang F, Liu J, Li D, Fu S, Pan A, Yu L, Zhang L, Chen T, Zhan L, Qin B, Lin F, Xiong X, Zhu Y, He Z, Sun R, Sun T, Qian S, Wen D, Zou X, Qi H, Shu H, Song L, Wang C, Shang Y. Short-term light sedation with remimazolam besylate versus propofol in the ICU (SHOSREB): a multicentre, randomized, single-blind, controlled trial. Intensive Care Med. 2026 May;52(5):1001-1011. doi: 10.1007/s00134-026-08381-x. Epub 2026 Mar 31.
- Derived from this study: PubMed 40493335Tang Y, Shu H, Ren L, Li R, Zou X, Qi H, Ouyang Y, Wu Y, Xu J, Fang X, Yang X, Shang Y. Remimazolam Besylate Versus Propofol for Short-Term Sedation in Critically Ill Patients Receiving Mechanical Ventilation: Protocol for a Multicenter Randomized Non-inferior Trial. Adv Ther. 2025 Aug;42(8):4081-4088. doi: 10.1007/s12325-025-03268-7. Epub 2025 Jun 10.
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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.
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, Propofol and Remifentanil in people with Sedative 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: finished, as of the sponsor's last update on 31 Jan 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Successful sedation (time frame: 24 hours). 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 NCT05782894, which also lists 2 linked publications.
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 31 Jan 2024.