Intensive Care UnitPhase 4NCT05480787
Pharmacokinetic Study of Continuous Infusion of Remazolam in Mechanically Ventilated Patients in ICU
A Phase 4 study testing Remimazolam 0.1mg/kg/h, Remimazolam 0.3mg/kg/h and Remimazolam 0.5mg/kg/h in people with Intensive Care Unit and Mechanical Ventilation, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
To study the pharmacokinetics of continuous infusion of remazolam in ICU mechanically ventilated critically ill patients, and the characteristics of PK in patients with liver failure; to explore whether liver failure affects the metabolism of remazolam by established population pharmacokinetics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit, Mechanical Ventilation, Anesthesia
- What is being tested?
- Remimazolam 0.1mg/kg/h, Remimazolam 0.3mg/kg/h and Remimazolam 0.5mg/kg/h
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 1 Sep 2022
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to ICU for tracheal intubation and mechanical; Patients aged >18 years; Patients with expected mechanical ventialation time >24 hours.
Who cannot join
- Patients on long-term anti-anxiety medication or sleeping pills; Patients with known or suspected hypersensitivity to remimazolam; Patients with severe central nervous system diseases; Patients who do not wish to sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 225500
About this study
Official title: Pharmacokinetic Study of Continuous Infusion of Remazolam in Mechanically Ventilated Patients in ICU : Establishment of Population Pharmacokinetic Model and Exploration of Clinical Influencing Factors
To study the pharmacokinetics of continuous infusion of remazolam in ICU mechanically ventilated critically ill patients, and the characteristics of PK in patients with liver failure; to explore whether liver failure affects the metabolism of remazolam by established population pharmacokinetics.
- Being tested
- Remimazolam 0.1mg/kg/h, Remimazolam 0.3mg/kg/h, Remimazolam 0.5mg/kg/h
- Keywords
- Remimazolam, Intensive Care Unit, Mechanical Ventilation, Anesthesia, Sedation, Liver Failure, Pharmacokinetics
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam 0.1mg/kg/hDrug
Remimazolam Tosilate for Injection(36mg)
Remimazolam 0.3mg/kg/hDrug
Remimazolam Tosilate for Injection(36mg)
Remimazolam 0.5mg/kg/hDrug
Remimazolam Tosilate for Injection(36mg)
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam 0.1mg/kg/h | Experimental | Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.1 mg/kg/h. Receives: Drug: Remimazolam 0.1mg/kg/h |
| Remimazolam 0.3mg/kg/h | Experimental | Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.3 mg/kg/h. Receives: Drug: Remimazolam 0.3mg/kg/h |
| Remimazolam 0.5mg/kg/h | Experimental | Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.5 mg/kg/h. Receives: Drug: Remimazolam 0.5mg/kg/h |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of Remimazolam
Plasma concentration of Remimazolam
Measured: 24 hours
Secondary outcomes (1)
Adverse reactions
Adverse reaction that patients experience with the medication,such as hypertension,hypotension,rapid heart rate,slow heart rate
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Feb 2022
- Primary completion15 Aug 2022 (estimated)
- Study completion1 Sep 2022 (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 Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480787
- Sponsor's protocol ID
- 2020120989remimazolam
- Status last verified
- Jul 2022
- First submitted
- 27 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hu J, Zhao Y, Shao L, Zhang W, Wang H, Liu Y, Su M, Zuo X. Pharmacokinetic Properties and Therapeutic Effectiveness of Remimazolam in ICU Patients With Mechanical Ventilation: A Preliminary Study. Pharmacol Res Perspect. 2025 Jun;13(3):e70130. doi: 10.1002/prp2.70130.
PubMed 40517312
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Continuous Infusion of Remazolam in Mechanically Ventilated Patients in ICU : Establishment of Population Pharmacokinetic Model and Exploration of Clinical Influencing Factors
- ClinicalTrials.gov ID
- NCT05480787
- Acronym / sponsor ID
- 2020120989remimazolam
- Keywords
- Remimazolam, Intensive Care Unit, Mechanical Ventilation, Anesthesia, Sedation, Liver Failure, Pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 29 Jul 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.
To study the pharmacokinetics of continuous infusion of remazolam in ICU mechanically ventilated critically ill patients, and the characteristics of PK in patients with liver failure; to explore whether liver failure affects the metabolism of remazolam by established population pharmacokinetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remimazolam 0.1mg/kg/h | Experimental | Drug: Remimazolam 0.1mg/kg/hParticipants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.1 mg/kg/h. |
| Remimazolam 0.3mg/kg/h | Experimental | Drug: Remimazolam 0.3mg/kg/hParticipants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.3 mg/kg/h. |
| Remimazolam 0.5mg/kg/h | Experimental | Drug: Remimazolam 0.5mg/kg/hParticipants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.5 mg/kg/h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to ICU for tracheal intubation and mechanical; Patients aged >18 years; Patients with expected mechanical ventialation time >24 hours.
Key exclusion criteria (1 listed)
- Patients on long-term anti-anxiety medication or sleeping pills; Patients with known or suspected hypersensitivity to remimazolam; Patients with severe central nervous system diseases; Patients who do not wish to sign the informed consent form.
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 0.1mg/kg/hRemimazolam Tosilate for Injection(36mg) | Drug | Remimazolam 0.1mg/kg/h |
| Remimazolam 0.3mg/kg/hRemimazolam Tosilate for Injection(36mg) | Drug | Remimazolam 0.3mg/kg/h |
| Remimazolam 0.5mg/kg/hRemimazolam Tosilate for Injection(36mg) | Drug | Remimazolam 0.5mg/kg/h |
Primary outcome
Plasma concentration of Remimazolam
Time frame: 24 hours
Plasma concentration of Remimazolam
1 secondary outcome
Adverse reactions
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Derived from this study: PubMed 40517312Hu J, Zhao Y, Shao L, Zhang W, Wang H, Liu Y, Su M, Zuo X. Pharmacokinetic Properties and Therapeutic Effectiveness of Remimazolam in ICU Patients With Mechanical Ventilation: A Preliminary Study. Pharmacol Res Perspect. 2025 Jun;13(3):e70130. doi: 10.1002/prp2.70130.
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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 4 study testing Remimazolam 0.1mg/kg/h, Remimazolam 0.3mg/kg/h and Remimazolam 0.5mg/kg/h in people with Intensive Care Unit and Mechanical Ventilation, run by The First Affiliated Hospital with Nanjing Medical University 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 1 inclusion and 1 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 29 Jul 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
Plasma concentration of Remimazolam (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 NCT05480787, 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 29 Jul 2022.