Sedation in the ICUPhase 3NCT06222294
A Study of Remimazolam Tosilate for Sedation in the ICU
A Phase 3 study testing Remimazolam Tosilate and Propofol Medium and Long Chain Fat Emulsion Injection in people with Sedation in the ICU, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sedation in the ICU
- What is being tested?
- Remimazolam Tosilate and Propofol Medium and Long Chain Fat Emulsion Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2024to 24 Sep 2024
- 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
- Patients and/or their guardians are able to provide a written informed consent, understand and agree to comply with the study requirements and protocol.
- Subjects have been treated with endotracheal intubation and mechanical ventilation, and are expected to receive sedation after randomization at least 6 hours. The target sedation level during the period is -2 ≤ RASS ≤ +1.
- 18 years to 80 years old, male or female.
- 18 kg/m2 ≤ BMI ≤ 30 kg/m2.
Who cannot join
- Deep sedation is required, or continuous sedation is not needed during the study process.
- Participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation.
- History of epilepsy or status epilepticus.
- Myasthenia gravis or a history of myasthenia gravis.
- Severe arrhythmias or heart disease; the circulatory system is unstable.
- Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness.
Show all 13Show fewer
- Subjects with a history of drug abuse.
- Organ failure before randomization.
- Abnormal values of the laboratory examination.
- Allergic to relevant drugs ingredient or component.
- Pregnant or nursing women.
- Subjects who has participated in clinical trials of other interventions recently.
- Other conditions deemed unsuitable to be included.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: A Multi-center, Randomized, Single-blind, Parallel Controlled With Active Drug, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in the Intensive Care Unit (ICU)
The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.
- Conditions
- Sedation in the ICU
- Being tested
- Remimazolam Tosilate, Propofol Medium and Long Chain Fat Emulsion Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam TosilateDrug
Loading dose: 0.08mg/kg Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1-0.2mg/kg/h
Propofol Medium and Long Chain Fat Emulsion InjectionDrug
Loading dose: 0.3-0.5mg/kg Maintenance dose: IV Propofol Medium and Long Chain Fat Emulsion Injection, dose range 0.3-4.0mg/kg/h, increment or decrement of 0.3-0.6mg/kg/h
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam Tosilate for Injection | Experimental | Not described Receives: Drug: Remimazolam Tosilate |
| Propofol Medium and Long Chain Fat Emulsion Injection | Active comparator | Not described Receives: Drug: Propofol Medium and Long Chain Fat Emulsion Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of sedation success, sedation success is defined as the percentage of time maintaining target sedation in the entire drug administering time ≥ 70% without rescue sedation.
Measured: within 24 hours after administration of research drug
Secondary outcomes (7)
Percentage of time maintaining target sedation in the entire drug administering time.
Measured: within 24 hours after administration of research drug
Percentage of subjects receiving rescue sedation
Measured: within 24 hours after administration of research drug
The number of additional doses of the research drug
Measured: within 24 hours after administration of research drug]
The total dosage of Fentanyl
Measured: within 24 hours after administration of research drug
Wake-up time.
Measured: within 6 hours after stopping the research drug
Stopping the research drug to extubation time.
Measured: within 6 hours after stopping the research drug
Nursing scale score
Measured: follow-up period (approx. 5-10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start12 Mar 2024
- Primary completion13 Aug 2024
- Study completion24 Sep 2024
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 Sedation in the ICUStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222294
- Sponsor's protocol ID
- HR7056-302
- Status last verified
- Jan 2026
- First submitted
- 28 Dec 2023
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guan X, Liu N, Lin F, Yu J, Yang M, Zhou Q, Chen K, Yu X, Huang X, Zhu J, Lyu J, Gui C, Hu Z, Zheng S, He B, Wang M, Yu Z, Ma X, Lv A, Zhang J, Xu J, Ye J, Gong J, Tian X, Zhou J, Zhou F, Yu L, He W, Li X, Yin T, Zhao H, Ding Y, Chen M. Efficacy and Safety of Remimazolam Tosylate versus Propofol for Sedation of Postoperative Mechanically Ventilated Patients in Intensive Care Units: A Multicenter, Randomized, Single-blind, Noninferiority, Phase 3 Trial. Anesthesiology. 2026 Jul 1;145(1):72-83. doi: 10.1097/ALN.0000000000006047. Epub 2026 Mar 19.
PubMed 41855428
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Single-blind, Parallel Controlled With Active Drug, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in the Intensive Care Unit (ICU)
- ClinicalTrials.gov ID
- NCT06222294
- Acronym / sponsor ID
- HR7056-302
- Conditions
- Sedation in the ICU
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 24 Jan 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.
The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam Tosilate for Injection | Experimental | Drug: Remimazolam Tosilate |
| Propofol Medium and Long Chain Fat Emulsion Injection | Active comparator | Drug: Propofol Medium and Long Chain Fat Emulsion Injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients and/or their guardians are able to provide a written informed consent, understand and agree to comply with the study requirements and protocol.
- Subjects have been treated with endotracheal intubation and mechanical ventilation, and are expected to receive sedation after randomization at least 6 hours. The target sedation level during the period is -2 ≤ RASS ≤ +1.
- 18 years to 80 years old, male or female.
- 18 kg/m2 ≤ BMI ≤ 30 kg/m2.
Key exclusion criteria (13 listed)
- Deep sedation is required, or continuous sedation is not needed during the study process.
- Participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation.
- History of epilepsy or status epilepticus.
- Myasthenia gravis or a history of myasthenia gravis.
- Severe arrhythmias or heart disease; the circulatory system is unstable.
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 TosilateLoading dose: 0.08mg/kg Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1-0.2mg/kg/h | Drug | Remimazolam Tosilate for Injection |
| Propofol Medium and Long Chain Fat Emulsion InjectionLoading dose: 0.3-0.5mg/kg Maintenance dose: IV Propofol Medium and Long Chain Fat Emulsion Injection, dose range 0.3-4.0mg/kg/h, increment or decrement of 0.3-0.6mg/kg/h | Drug | Propofol Medium and Long Chain Fat Emulsion Injection |
Primary outcome
Rate of sedation success, sedation success is defined as the percentage of time maintaining target sedation in the entire drug administering time ≥ 70% without rescue sedation.
Time frame: within 24 hours after administration of research drug
7 secondary outcomes
Percentage of time maintaining target sedation in the entire drug administering time.
Time frame: within 24 hours after administration of research drug
Percentage of subjects receiving rescue sedation
Time frame: within 24 hours after administration of research drug
The number of additional doses of the research drug
Time frame: within 24 hours after administration of research drug]
The total dosage of Fentanyl
Time frame: within 24 hours after administration of research drug
Wake-up time.
Time frame: within 6 hours after stopping the research drug
Stopping the research drug to extubation time.
Time frame: within 6 hours after stopping the research drug
Nursing scale score
Time frame: follow-up period (approx. 5-10 minutes)
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 9 Jan 2026.
- Derived from this study: PubMed 41855428Guan X, Liu N, Lin F, Yu J, Yang M, Zhou Q, Chen K, Yu X, Huang X, Zhu J, Lyu J, Gui C, Hu Z, Zheng S, He B, Wang M, Yu Z, Ma X, Lv A, Zhang J, Xu J, Ye J, Gong J, Tian X, Zhou J, Zhou F, Yu L, He W, Li X, Yin T, Zhao H, Ding Y, Chen M. Efficacy and Safety of Remimazolam Tosylate versus Propofol for Sedation of Postoperative Mechanically Ventilated Patients in Intensive Care Units: A Multicenter, Randomized, Single-blind, Noninferiority, Phase 3 Trial. Anesthesiology. 2026 Jul 1;145(1):72-83. doi: 10.1097/ALN.0000000000006047. Epub 2026 Mar 19.
- Individual participant dataSharing planned: Undecided
Related trials for Sedation in the ICU
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
RecruitingPhase 3
Ketamine Sedation in the ICU (KANINE) RCT
Mechanical Ventilation, Critically Ill Intensive Care Unit Patients
Not yet recruiting
Dexametedomidine Ketamine Infusion Versus Dexametedomidine Propofol Infusion in Non-compliant Agitated Patients on Continuous Positive Airway Pressure (CPAP) Mask Ventilation in the Intensive Care Unit
CPAP Ventilation, Sedation
Enrolling by invitation
Weighted Blanket to Improve Sedation and Comfort During Ventilator Weaning
Ventilated Patient in Intensive Care
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 Tosilate and Propofol Medium and Long Chain Fat Emulsion Injection in people with Sedation in the ICU, run by Jiangsu HengRui Medicine Co., Ltd. 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 13 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 9 Jan 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 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?
Rate of sedation success, sedation success is defined as the percentage of time maintaining target sedation in the entire drug administering time ≥ 70% without rescue sedation. (time frame: within 24 hours after administration of research 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 NCT06222294, 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 9 Jan 2026.