Sedation in the ICUPhase 2NCT05152303
A Study of Remimazolam Tosilate for Sedation in the ICU
A Phase 2 study testing Remimazolam Tosilate in people with Sedation in the ICU, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2022to 19 Apr 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
- Patients or their guardians are able to provide a written informed consent
- Subjects have been treated with endotracheal intubation and mechanical ventilation, and is expected to receive sedation after randomization. The target level and duration of sedation meet the criteria
- Meet the age criteria, male or female
- Meet the BMI criteria
Who cannot join
- Deep sedation is required, or continuous sedation is not needed during the study process
- Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness
- Subjects with a history of drug abuse
- Subjects after neurosurgery operation
- Organ failure before randomization
- Abnormal values of the laboratory examination
Show all 10Show fewer
- Abnormal blood pressure and heart rate during screening
- Allergic to relevant drugs ingredient or component
- Pregnant or nursing women
- Subjects who has participated in clinical trials of other interventions recently
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in the Intensive Care Unit (ICU) - a Multicenter, Randomized, Single Blind, Dose Finding Phase II Clinical Trial
The purpose of this study is to explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.
- Conditions
- Sedation in the ICU
- Being tested
- Remimazolam Tosilate
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 IV of Remimazolam Tosilate, Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1mg/kg/h
Remimazolam TosilateDrug
Loading dose: 0.08mg/kg, Drug: Propofol Injection Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.2mg/kg/h IV of Propofol Injection
| Study group | Role | What they receive |
|---|---|---|
| A：Remimazolam Tosilate | Experimental | Not described Receives: Drug: Remimazolam Tosilate |
| B：Remimazolam Tosilate | Experimental | Not described Receives: Drug: Remimazolam Tosilate |
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 and the average dosage of rescue sedation
Measured: within 24 hours after administration of research drug
Percentage of subjects receiving rescue analgesia and the average dosage of rescue analgesiaassessment time point after drug administering.
Measured: within 24 hours after administration of research drug
The number of times to change the infusion rate
Measured: within 24 hours after administration of research drug
Wake-up time.
Measured: within 8 hours after stopping the research drug
Evaluation of nursing difficulty.
Measured: follow-up period (approx. 5-10 minutes)
Mechanical ventilation time.
Measured: at the time of extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start12 Oct 2022
- Primary completion2 Apr 2023
- Study completion19 Apr 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 Sedation in the ICUStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Multicenter, Randomized, Single Blind, Dose Finding, Phase II Clinical Trial to explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152303
- Sponsor's protocol ID
- HR7056-205
- Status last verified
- Apr 2023
- First submitted
- 29 Nov 2021
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu N, Lin F, Wen J, Yu X, Zhou F, Yu Z, Yang M, Yu L, Lv A, Sun Y, Shen F, He B, Hu Z, Yin T, Li X, Zhao H, Wu J, Chen C, Nie Y, Zuo L, Guan X, Chen M. Efficacy and safety of remimazolam tosylate for sedation in ICU patients: A multicenter, randomized, phase 2 study. J Intensive Med. 2026 Mar 28;6(3):247-254. doi: 10.1016/j.jointm.2026.01.009. eCollection 2026 Jun.
PubMed 42164575Liu N, Jiang Z, Nie Y, Zuo L, Chen C, Si X, Liu Q, Chen M, Guan X. Study Protocol of a Multicenter, Randomized, Single-Blind Trial: Efficacy and Safety of Remimazolam Tosylate for Sedation in ICU Patients. Adv Ther. 2023 May;40(5):2524-2533. doi: 10.1007/s12325-023-02456-7. Epub 2023 Mar 15.
PubMed 36920745
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in the Intensive Care Unit (ICU) - a Multicenter, Randomized, Single Blind, Dose Finding Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT05152303
- Acronym / sponsor ID
- HR7056-205
- Conditions
- Sedation in the ICU
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 2 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 9 Dec 2021 (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 explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily 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
- Model description
- This is a Multicenter, Randomized, Single Blind, Dose Finding, Phase II Clinical Trial to explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU
| Arm | Type | Receives |
|---|---|---|
| A：Remimazolam Tosilate | Experimental | Drug: Remimazolam Tosilate |
| B：Remimazolam Tosilate | Experimental | Drug: Remimazolam Tosilate |
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 or their guardians are able to provide a written informed consent
- Subjects have been treated with endotracheal intubation and mechanical ventilation, and is expected to receive sedation after randomization. The target level and duration of sedation meet the criteria
- Meet the age criteria, male or female
- Meet the BMI criteria
Key exclusion criteria (10 listed)
- Deep sedation is required, or continuous sedation is not needed during the study process
- Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness
- Subjects with a history of drug abuse
- Subjects after neurosurgery operation
- Organ failure before randomization
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 IV of Remimazolam Tosilate, Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1mg/kg/h | Drug | A：Remimazolam Tosilate |
| Remimazolam TosilateLoading dose: 0.08mg/kg, Drug: Propofol Injection Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.2mg/kg/h IV of Propofol Injection | Drug | B：Remimazolam Tosilate |
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 and the average dosage of rescue sedation
Time frame: within 24 hours after administration of research drug
Percentage of subjects receiving rescue analgesia and the average dosage of rescue analgesiaassessment time point after drug administering.
Time frame: within 24 hours after administration of research drug
The number of times to change the infusion rate
Time frame: within 24 hours after administration of research drug
Wake-up time.
Time frame: within 8 hours after stopping the research drug
Evaluation of nursing difficulty.
Time frame: follow-up period (approx. 5-10 minutes)
Mechanical ventilation time.
Time frame: at the time of extubation
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 23 May 2023.
- Derived from this study: PubMed 42164575Liu N, Lin F, Wen J, Yu X, Zhou F, Yu Z, Yang M, Yu L, Lv A, Sun Y, Shen F, He B, Hu Z, Yin T, Li X, Zhao H, Wu J, Chen C, Nie Y, Zuo L, Guan X, Chen M. Efficacy and safety of remimazolam tosylate for sedation in ICU patients: A multicenter, randomized, phase 2 study. J Intensive Med. 2026 Mar 28;6(3):247-254. doi: 10.1016/j.jointm.2026.01.009. eCollection 2026 Jun.
- Derived from this study: PubMed 36920745Liu N, Jiang Z, Nie Y, Zuo L, Chen C, Si X, Liu Q, Chen M, Guan X. Study Protocol of a Multicenter, Randomized, Single-Blind Trial: Efficacy and Safety of Remimazolam Tosylate for Sedation in ICU Patients. Adv Ther. 2023 May;40(5):2524-2533. doi: 10.1007/s12325-023-02456-7. Epub 2023 Mar 15.
- 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.
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 Tosilate in people with Sedation in the ICU, run by Fujian Shengdi Pharmaceutical 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 10 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 23 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 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?
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 NCT05152303, 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 23 May 2023.