Local Anesthesia Assisted SedationPhase 2NCT05015361
A Trial of Efficacy and Safety of Remimazolam Tosilate for Injection in Local Anesthesia Assisted Sedation
A Phase 2 study testing Remimazolam Tosilate and Propofol Injection. in people with Local Anesthesia Assisted Sedation, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Remimazolam Tosilate for injection in local anesthesia assisted sedation, and to explore the dose range of remazolam toluenesulfonate for injection in local anesthesia assisted sedation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Local Anesthesia Assisted Sedation
- What is being tested?
- Remimazolam Tosilate and Propofol Injection.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2021to 4 Jul 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide a written informed consent
- Subjects requiring local anesthesia assisted sedation
- Male or female
- Meet the weight standard
- Conform to the ASA Physical Status Classification
Who cannot join
- Previous respiratory or pulmonary diseases
- Subjects who had received general anesthesia
- Subjects with a history of myocardial infarction or unstable angina pectoris
- Subjects with atrioventricular block or cardiac insufficiency
- Subjects with a history of ischemic stroke or transient ischemic attack
- Subjects with poor blood pressure control after medication
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- Subjects with abnormal clotting function
- Subjects with a history of mental illness and a history of cognitive impairment epilepsy
- Subjects with a history or possibility of a difficult airway
- Subject with a history of substance abuse and drug abuse
- Abnormal values in the laboratory
- Allergic to a drug ingredient or component
- Pregnant or nursing women
- No birth control during the specified period of time
- Participated in clinical trials of other drugs (received experimental drugs)
- The inestigators determined that other conditions were inappropriate for participation in this clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Remimazolam Tosilate for Injection in Local Anesthesia Assisted Sedation -- a Multicenter, Randomized, Single Blind, Positive Drug Parallel Controlled Phase II Clinical Trial
To evaluate the efficacy and safety of Remimazolam Tosilate for injection in local anesthesia assisted sedation, and to explore the dose range of remazolam toluenesulfonate for injection in local anesthesia assisted sedation.
- Conditions
- Local Anesthesia Assisted Sedation
- Being tested
- Remimazolam Tosilate, Propofol Injection.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam TosilateDrug
Treatment group A: Remimazolam Tosilate; high dose Treatment group B: Remimazolam Tosilate; low dose
Propofol Injection.Drug
Treatment group C: Propofol Injection.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A/B | Experimental | Treatment group A: Remimazolam Tosilate Treatment group B: Remimazolam Tosilate Receives: Drug: Remimazolam Tosilate |
| Treatment group C | Active comparator | Treatment group C: Propofol Injection. Receives: Drug: Propofol Injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to maintain target sedation as a percentage of the total study administration time.
Measured: through study completion,an average of about 1 hour
Secondary outcomes (7)
Proportion of subjects who achieved target sedation within 3 minutes after starting intravenous injection of load dose test drugs;
Measured: 3 minutes after administration
Proportion of subjects receiving remedial sedation;
Measured: through study completion,an average of about 1 hour
The time from the start of intravenous injection of load dose test drug to the first achievement of target sedation;
Measured: Time to achieve target sedation, an average of about 4 minutes
The time from stopping infusion of test drugs to reaching MOAA/S level 5 for the first time after operation
Measured: Recovery time, an average of about 7 minutes
Anesthesiologists' satisfaction with sedation
Measured: through study completion,an average of about 1 hour
Evaluation of subjects' satisfaction with sedation treatment;
Measured: through study completion,an average of about 1 hour
Incidence of anterograde amnesia.
Measured: through study completion,an average of about 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start7 May 2021
- Primary completion18 Jun 2021
- Study completion4 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Anesthesia Assisted SedationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Remimazolam Tosilate compared with Propofol Injection
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 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
- NCT05015361
- Sponsor's protocol ID
- HR7056-204
- Status last verified
- Aug 2021
- First submitted
- 11 Aug 2021
- Last updated
- 20 Aug 2021
- 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 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Remimazolam Tosilate for Injection in Local Anesthesia Assisted Sedation -- a Multicenter, Randomized, Single Blind, Positive Drug Parallel Controlled Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT05015361
- Acronym / sponsor ID
- HR7056-204
- Conditions
- Local Anesthesia Assisted Sedation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 May 2021 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 4 Jul 2021 (actual)
- First posted
- 20 Aug 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.
To evaluate the efficacy and safety of Remimazolam Tosilate for injection in local anesthesia assisted sedation, and to explore the dose range of remazolam toluenesulfonate for injection in local anesthesia assisted sedation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Remimazolam Tosilate compared with Propofol Injection
| Arm | Type | Receives |
|---|---|---|
| Treatment group A/B | Experimental | Drug: Remimazolam TosilateTreatment group A: Remimazolam Tosilate Treatment group B: Remimazolam Tosilate |
| Treatment group C | Active comparator | Drug: Propofol Injection.Treatment group C: Propofol Injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able and willing to provide a written informed consent
- Subjects requiring local anesthesia assisted sedation
- Male or female
- Meet the weight standard
- Conform to the ASA Physical Status Classification
Key exclusion criteria (16 listed)
- Previous respiratory or pulmonary diseases
- Subjects who had received general anesthesia
- Subjects with a history of myocardial infarction or unstable angina pectoris
- Subjects with atrioventricular block or cardiac insufficiency
- Subjects with a history of ischemic stroke or transient ischemic attack
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 TosilateTreatment group A: Remimazolam Tosilate; high dose Treatment group B: Remimazolam Tosilate; low dose | Drug | Treatment group A/B |
| Propofol Injection.Treatment group C: Propofol Injection. | Drug | Treatment group C |
Primary outcome
The time to maintain target sedation as a percentage of the total study administration time.
Time frame: through study completion,an average of about 1 hour
7 secondary outcomes
Proportion of subjects who achieved target sedation within 3 minutes after starting intravenous injection of load dose test drugs;
Time frame: 3 minutes after administration
Proportion of subjects receiving remedial sedation;
Time frame: through study completion,an average of about 1 hour
The time from the start of intravenous injection of load dose test drug to the first achievement of target sedation;
Time frame: Time to achieve target sedation, an average of about 4 minutes
The time from stopping infusion of test drugs to reaching MOAA/S level 5 for the first time after operation
Time frame: Recovery time, an average of about 7 minutes
Anesthesiologists' satisfaction with sedation
Time frame: through study completion,an average of about 1 hour
Evaluation of subjects' satisfaction with sedation treatment;
Time frame: through study completion,an average of about 1 hour
Incidence of anterograde amnesia.
Time frame: through study completion,an average of about 1 hour
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 20 Aug 2021.
- Individual participant dataSharing planned: Undecided
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 and Propofol Injection. in people with Local Anesthesia Assisted Sedation, 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 16 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 20 Aug 2021. 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?
The time to maintain target sedation as a percentage of the total study administration time. (time frame: through study completion,an average of about 1 hour). 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 20 Aug 2021.