Sedation in Non-intubated Diagnostic and Therapeutic ProceduresPhase 4NCT06216444
A Study of Remimazolam Tosilate for Sedation in Non-intubated Diagnostic and Therapeutic Procedures
A Phase 4 study testing Remimazolam Tosilate for Injection in people with Sedation in Non-intubated Diagnostic and Therapeutic Procedures, 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 non-intubated diagnostic and therapeutic procedures Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedation in Non-intubated Diagnostic and Therapeutic Procedures
- What is being tested?
- Remimazolam Tosilate for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Jan 2024to Mar 2024
- 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
- Age ≥18 years old, male or female
- Intending to undergo routine gastroscopy or colonoscopy
- ASA (American Society of Anesthesiologists) I to III
- 18 kg/m2≤BMI (Body Mass Index)≤30kg/m2
- Signed informed consent
Who cannot join
- Subjects need to be tracheal intubation
- Subjects need to be complicated endoscopic diagnostic and therapeutic procedures
- Subjects who have had severe cardiovascular diseases or severe arrhythmias within 6 months prior to signing the ICF
- Heart rate <50 beats/min during the screening period
- Poor blood pressure control during the screening period
- Subjects with severe respiratory diseases
Show all 13Show fewer
- Subjects with respiratory management difficulties (Modified Mallampati grade IV)
- Subjects with a history of mental illness (schizophrenia, mania, bipolar disorder, psychosis, etc.), long-term use of psychotropic drugs, and cognitive impairment
- A history of drug abuse or addiction within 2 years prior to signing the ICF
- Pregnant women or those in lactation period
- Allergic to relevant drugs ingredient or component in the study
- Currently participating in or planning to participate in other drug or device clinical trials during this study
- Other conditions deemed unsuitable to be included
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Changhong Miao
About this study
Official title: A Multi-center, Randomized, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Remimazolam Tosilate (Ruibeining®) for Injection for Sedation in Non-intubated Diagnostic and Therapeutic Procedures
The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in non-intubated diagnostic and therapeutic procedures
- Being tested
- Remimazolam Tosilate for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam Tosilate for InjectionDrug
Initial loading dose of 5mg, with additional doses of 2.5mg as necessary
Remimazolam Tosilate for InjectionDrug
Initial loading dose of 10mg, with additional doses of 2.5mg as necessary
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam Tosilate for Injection（5mg） | Experimental | Not described Receives: Drug: Remimazolam Tosilate for Injection |
| Remimazolam Tosilate for Injection（10mg） | Experimental | Not described Receives: Drug: Remimazolam Tosilate for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of sedation success, Sedation success
Rate of sedation success, Sedation success is defined as: 1) Completion of the entire non-intubated diagnostic and therapeutic procedure; 2) No need for additional rescue sedation; 3) During the sedation induction phase, the MOAA/S score should be ≤3 within 2 minutes after the end of the initial dose administration or after ≤2 additional administrations; 4) No more than 2 additional administrations in every 5-minute.
Measured: day 1
Secondary outcomes (11)
Number of additional administrations.
Measured: day 1
Percentage of subjects needing additional administration.
Measured: day 1
One-time success rate of endoscope insertion during the diagnostic and therapeutic procedure.
Measured: day 1
Rate of over-sedation.
Measured: day 1
Sedation induction time
Measured: day 1
Wake-up time.
Measured: day 1
Time to discharge.
Measured: day 1
Rate of sedation-related hypotension and rate of sedation-related hypotension needing treatment.
Measured: day 1
Rate of respiratory depression during sedation.
Measured: day 1
Investigator's Satisfaction with Sedation Assessment: The scoring range is from 0 to 10, where 0 represents dissatisfaction and 10 represents complete satisfaction.
Measured: day 1
Participant's satisfaction with Sedation Assessment: The scoring range is from 0 to 10, where 0 represents dissatisfaction and 10 represents complete satisfaction.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation in Non-intubated Diagnostic and Therapeutic ProceduresStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (estimated)
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
- NCT06216444
- Sponsor's protocol ID
- HR7056-401
- Status last verified
- Dec 2023
- First submitted
- 27 Dec 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Remimazolam Tosilate (Ruibeining®) for Injection for Sedation in Non-intubated Diagnostic and Therapeutic Procedures
- ClinicalTrials.gov ID
- NCT06216444
- Acronym / sponsor ID
- HR7056-401
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2024 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 22 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 non-intubated diagnostic and therapeutic procedures
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（5mg） | Experimental | Drug: Remimazolam Tosilate for Injection |
| Remimazolam Tosilate for Injection（10mg） | Experimental | Drug: Remimazolam Tosilate for Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years old, male or female
- Intending to undergo routine gastroscopy or colonoscopy
- ASA (American Society of Anesthesiologists) I to III
- 18 kg/m2≤BMI (Body Mass Index)≤30kg/m2
- Signed informed consent
Key exclusion criteria (13 listed)
- Subjects need to be tracheal intubation
- Subjects need to be complicated endoscopic diagnostic and therapeutic procedures
- Subjects who have had severe cardiovascular diseases or severe arrhythmias within 6 months prior to signing the ICF
- Heart rate <50 beats/min during the screening period
- Poor blood pressure control during the screening period
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 Tosilate for InjectionInitial loading dose of 5mg, with additional doses of 2.5mg as necessary | Drug | Remimazolam Tosilate for Injection（5mg） |
| Remimazolam Tosilate for InjectionInitial loading dose of 10mg, with additional doses of 2.5mg as necessary | Drug | Remimazolam Tosilate for Injection（10mg） |
Primary outcome
Rate of sedation success, Sedation success
Time frame: day 1
Rate of sedation success, Sedation success is defined as: 1) Completion of the entire non-intubated diagnostic and therapeutic procedure; 2) No need for additional rescue sedation; 3) During the sedation induction phase, the MOAA/S score should be ≤3 within 2 minutes after the end of the initial dose administration or after ≤2 additional administrations; 4) No more than 2 additional administrations in every 5-minute.
11 secondary outcomes
Number of additional administrations.
Time frame: day 1
Percentage of subjects needing additional administration.
Time frame: day 1
One-time success rate of endoscope insertion during the diagnostic and therapeutic procedure.
Time frame: day 1
Rate of over-sedation.
Time frame: day 1
Sedation induction time
Time frame: day 1
Wake-up time.
Time frame: day 1
Time to discharge.
Time frame: day 1
Rate of sedation-related hypotension and rate of sedation-related hypotension needing treatment.
Time frame: day 1
Rate of respiratory depression during sedation.
Time frame: day 1
Investigator's Satisfaction with Sedation Assessment: The scoring range is from 0 to 10, where 0 represents dissatisfaction and 10 represents complete satisfaction.
Time frame: day 1
Participant's satisfaction with Sedation Assessment: The scoring range is from 0 to 10, where 0 represents dissatisfaction and 10 represents complete satisfaction.
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- 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.
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 Tosilate for Injection in people with Sedation in Non-intubated Diagnostic and Therapeutic Procedures, 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 5 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: status not confirmed, as of the sponsor's last update on 22 Jan 2024. 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?
Contact Qin Liu (+0518-82342973, qin.liu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of sedation success, Sedation success (time frame: day 1). 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 22 Jan 2024.