Mechanically Ventilated PatientsPhase 2NCT06124404
Step 1 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients
A Phase 2 study testing Remimazolam besylate in people with Mechanically Ventilated Patients, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This is a Phase II, dose-escalation clinical trial conducted in mechanically ventilated patients receiving sedation no longer than 24 hours. The efficacy, safety, and pharmacokinetics of remimazolam besylate were evaluated using a randomized, single-blind design. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mechanically Ventilated Patients
- What is being tested?
- Remimazolam besylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2022to 28 Feb 2023
- Phase
- Phase 2
- 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
- Body mass index (BMI) ≥18 and ≤ 30 kg/m2
- Being Intubated and mechanically ventilated ≤48 hours before enrollment and expected to be on a 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 14Show 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 for 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
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
This is a Phase II, dose-escalation clinical trial conducted in mechanically ventilated patients receiving sedation no longer than 24 hours. The efficacy, safety, and pharmacokinetics of remimazolam besylate were evaluated using a randomized, single-blind design.
- Conditions
- Mechanically Ventilated Patients
- Being tested
- Remimazolam besylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam besylateDrug
Also called A maintaining dose of 0.1mg/kg/h
After a loading dose of 0.08mg/kg, a maintaining dose of 0.1mg/kg/h is given
Remimazolam besylateDrug
Also called A maintaining dose of 0.2mg/kg/h
After a loading dose of 0.08mg/kg, a maintaining dose of 0.2mg/kg/h is given
Remimazolam besylateDrug
Also called A maintaining dose of 0.4mg/kg/h
After a loading dose of 0.08mg/kg, a maintaining dose of 0.4mg/kg/h is given
| Study group | Role | What they receive |
|---|---|---|
| Small dose | Experimental | Not described Receives: Drug: Remimazolam besylate |
| Medium dose | Experimental | Not described Receives: Drug: Remimazolam besylate |
| Large dose | Experimental | Not described Receives: Drug: Remimazolam besylate |
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: Within 24 hours while receiving the study drug
Secondary outcomes (1)
Adverse drug reactions (ADRs)
Adverse drug reactions (ADRs)
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 posted9 Nov 2023
- Study start8 Apr 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
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 Mechanically Ventilated PatientsStudies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Yichang Humanwell Pharmaceutical Co., Ltd., China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124404
- Sponsor's protocol ID
- WHUICU202205
- Status last verified
- Feb 2023
- First submitted
- 29 Sep 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang X, Fu S, Yu L, Liang F, Li D, Sun R, Zhou X, Yu X, Tian L, Shang Y. Efficacy and safety of remimazolam besylate in patients receiving mechanical ventilation: A randomized phase Ⅱa trial. J Intensive Med. 2026 Jan 8;6(3):277-283. doi: 10.1016/j.jointm.2025.12.002. eCollection 2026 Jun.
PubMed 42164587
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. 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
- NCT06124404
- Acronym / sponsor ID
- WHUICU202205
- Conditions
- Mechanically Ventilated Patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 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
- 8 Apr 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 9 Nov 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.
This is a Phase II, dose-escalation clinical trial conducted in mechanically ventilated patients receiving sedation no longer than 24 hours. The efficacy, safety, and pharmacokinetics of remimazolam besylate were evaluated using a randomized, single-blind design.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Small dose | Experimental | Drug: Remimazolam besylate |
| Medium dose | Experimental | Drug: Remimazolam besylate |
| Large dose | Experimental | Drug: Remimazolam besylate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) ≥18 and ≤ 30 kg/m2
- Being Intubated and mechanically ventilated ≤48 hours before enrollment and expected to be on a 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 (14 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 besylateAlso: A maintaining dose of 0.1mg/kg/hAfter a loading dose of 0.08mg/kg, a maintaining dose of 0.1mg/kg/h is given | Drug | Small dose |
| Remimazolam besylateAlso: A maintaining dose of 0.2mg/kg/hAfter a loading dose of 0.08mg/kg, a maintaining dose of 0.2mg/kg/h is given | Drug | Medium dose |
| Remimazolam besylateAlso: A maintaining dose of 0.4mg/kg/hAfter a loading dose of 0.08mg/kg, a maintaining dose of 0.4mg/kg/h is given | Drug | Large dose |
Primary outcome
The percentage of time in the target sedation range without rescue sedation
Time frame: Within 24 hours while receiving the study drug
The percentage of time in the target sedation range without rescue sedation
1 secondary outcome
Adverse drug reactions (ADRs)
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 19 Mar 2026.
- Derived from this study: PubMed 42164587Yang X, Fu S, Yu L, Liang F, Li D, Sun R, Zhou X, Yu X, Tian L, Shang Y. Efficacy and safety of remimazolam besylate in patients receiving mechanical ventilation: A randomized phase Ⅱa trial. J Intensive Med. 2026 Jan 8;6(3):277-283. doi: 10.1016/j.jointm.2025.12.002. eCollection 2026 Jun.
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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 2 study testing Remimazolam besylate in people with Mechanically Ventilated Patients, 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 3 inclusion and 14 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 19 Mar 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The percentage of time in the target sedation range without rescue sedation (time frame: Within 24 hours while receiving the study drug). 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 NCT06124404, 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 19 Mar 2026.