SepsisPhase 4NCT06731088
Effect of Remazolam Besylate Combined With Remifentanil Analgesic Sedation on the Prognosis of Patients With Sepsis
A Phase 4 study testing Midazolam and Remazolam besylate in people with Sepsis, run by First Affiliated Hospital of Ningbo University at 1 site in China.
Trial summary
In this study, midazolam was used as a control to investigate the effect of remazolam besylate combined with remifentanil on analgesia and sedation in patients with mechanical ventilation of sepsis on the prognosis of patients, and to provide evidence for the safe application of remazolam besylate in patients with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Midazolam and Remazolam besylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanical ventilation patients with sepsis who are expected to stay in ICU for ≥48h;
- The condition was allowed to remain in shallow sedation (RASS-2 ~0);
- Obtain informed consent from patients or family members
Who cannot join
- pregnancy or breastfeeding;
- General anesthesia surgery within 48 hours;
- Severe, pre-existing parenchymatous liver disease with clinically significant portal hypertension, Child-Pugh grade C cirrhosis or acute liver failure;
- Patients with acute and chronic renal insufficiency requiring dialysis treatment;
- Severe craniocerebral injury, brain tumor, increased intracranial pressure, cerebrovascular accident, coma, epileptic status, etc. 6 Medical Ethics Committee of the First Affiliated Hospital of Ningbo University;
- Patients with a history of alcohol or drug abuse;
Show all 10Show fewer
- Any condition that prevents the correct assessment of cognitive function, such as speech and sensory disorders or mental disorders (language difficulties or organic mental dysfunction);
- Failure to obtain informed consent or authorization;
- Participate in other exploratory clinical trials within 6 months prior to screening;
- Known or suspected allergy to the study drug.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315040
About this study
In this study, midazolam was used as a control to investigate the effect of remazolam besylate combined with remifentanil on analgesia and sedation in patients with mechanical ventilation of sepsis on the prognosis of patients, and to provide evidence for the safe application of remazolam besylate in patients with sepsis.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Midazolam, a benzodiazepine sedative commonly used in ICU, acts on GABA receptors in the central nervous system to produce dose-related hypnosis, anti-pyroanxiety and anterograde amnesia, and has corresponding competitive antagonists [8]. It has rapid onset and short duration, but its deficiency lies in that the metabolites are still active. Thus easy accumulation, prolong the recovery time of patients
Remazolam besylateDrug
Remazolam besylate is a new type of benzodiazepine sedative drug metabolized by tissue esterase. It is not metabolized by liver and kidney, and is metabolized by tissue esterase rapidly in vivo to produce inactive metabolites.
| Study group | Role | What they receive |
|---|---|---|
| Midazolam | Active comparator | Not described Receives: Drug: Midazolam |
| Remazolam benzenesulfonate | Active comparator | Not described Receives: Drug: Remazolam besylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of days without delirium or coma during the 14-day intervention period.
Measured: From enrollment to the end of treatment at 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Ningbo University
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731088
- Sponsor's protocol ID
- FAHNBU20241244
- Status last verified
- Apr 2025
- First submitted
- 9 Dec 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remazolam Besylate Combined With Remifentanil Analgesic Sedation on the Prognosis of Patients With Sepsis
- ClinicalTrials.gov ID
- NCT06731088
- Acronym / sponsor ID
- FAHNBU20241244
- Conditions
- Sepsis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Ningbo UniversityResearch network
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Dec 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.
In this study, midazolam was used as a control to investigate the effect of remazolam besylate combined with remifentanil on analgesia and sedation in patients with mechanical ventilation of sepsis on the prognosis of patients, and to provide evidence for the safe application of remazolam besylate in patients with sepsis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam | Active comparator | Drug: Midazolam |
| Remazolam benzenesulfonate | Active comparator | Drug: Remazolam besylate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mechanical ventilation patients with sepsis who are expected to stay in ICU for ≥48h;
- The condition was allowed to remain in shallow sedation (RASS-2 ~0);
- Obtain informed consent from patients or family members
Key exclusion criteria (10 listed)
- pregnancy or breastfeeding;
- General anesthesia surgery within 48 hours;
- Severe, pre-existing parenchymatous liver disease with clinically significant portal hypertension, Child-Pugh grade C cirrhosis or acute liver failure;
- Patients with acute and chronic renal insufficiency requiring dialysis treatment;
- Severe craniocerebral injury, brain tumor, increased intracranial pressure, cerebrovascular accident, coma, epileptic status, etc. 6 Medical Ethics Committee of the First Affiliated Hospital of Ningbo University;
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 |
|---|---|---|
| MidazolamMidazolam, a benzodiazepine sedative commonly used in ICU, acts on GABA receptors in the central nervous system to produce dose-related hypnosis, anti-pyroanxiety and anterograde amnesia, and has corresponding competitive antagonists [8]. It has rapid onset and short duration, but its deficiency lies in that the metabolites are still active. Thus easy accumulation, prolong the recovery time of patients | Drug | Midazolam |
| Remazolam besylateRemazolam besylate is a new type of benzodiazepine sedative drug metabolized by tissue esterase. It is not metabolized by liver and kidney, and is metabolized by tissue esterase rapidly in vivo to produce inactive metabolites. | Drug | Remazolam benzenesulfonate |
Primary outcome
The number of days without delirium or coma during the 14-day intervention period.
Time frame: From enrollment to the end of treatment at 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
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 Midazolam and Remazolam besylate in people with Sepsis, run by First Affiliated Hospital of Ningbo 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 3 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: enrolling by invitation, as of the sponsor's last update on 10 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 number of days without delirium or coma during the 14-day intervention period. (time frame: From enrollment to the end of treatment at 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2025.