SedationPhase 3NCT04400201
A Clinical Study of Remimazolam Tosilate in Patients Undergoing Bronchoscopy
A Phase 3 study testing Remimazolam Tosilate and Propofol in people with Sedation, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
A multicenter, randomized, single-blind, active controlled, parallel group study comparing remimazolam tosilate to propofol in patients undergoing bronchoscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sedation
- What is being tested?
- Remimazolam Tosilate and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2020to 30 Oct 2020
- Phase
- Phase 3
- 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
- 18~80 years, female or male
- Patients scheduled for an bronchoscopy procedure
- 18 kg/m2<BMI<30kg/m2
- Patients understand clearly and participate in the study voluntarily, and sign the informed consent
Who cannot join
- Patients scheduled for emergency surgery
- Patients with a history of drug abuse and / or alcohol abuse 2 years prior to the screening period
- One or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
- Pregnant women or those in lactation period
- Allergic to drugs used in the study
- Patients have participated in other clinical trial within the 3 months prior to randomization
- Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the subject for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Clinical Study Evaluating the Efficacy and Safety of Remimazolam Tosilate Compared to Propofol in Patients Undergoing Bronchoscopy
A multicenter, randomized, single-blind, active controlled, parallel group study comparing remimazolam tosilate to propofol in patients undergoing bronchoscopy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam TosilateDrug
Intravenous injection at a dose of 0.3mg/kg for sedation induction and continuous intravenous infusion at an initiative dose of 1 mg/kg/h for sedation maintenance.
PropofolDrug
Intravenous injection at a dose of 1.5~2.5mg/kg for sedation induction and continuous intravenous infusion at the dose of 0~12 mg/kg/h for sedation maintenance
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam Tosilate | Experimental | Not described Receives: Drug: Remimazolam Tosilate |
| Propofol | Active comparator | Not described Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage (%) of participants who experienced successful sedation in undergoing bronchoscopy in each group
Measured: From the onset of administration of the study drug to removal of bronchoscope on Day 1 of treatment
Secondary outcomes (3)
Time from start of investigational medicinal product administration to loss of consciousness
Measured: From the onset of administration of the study drug to unconsciousness on Day 1 of treatment
Time from stop of investigational medicinal product to MOAA/S Score=5
Measured: From the last dose of study drug until the patient has recovered to fully alert on Day 1 of treatment
Time from stop of investigational medicinal product to Aldrete Score≥9
Measured: From the end of administration of the study drug until the patient reaches the modified Aldrete's system score of ≥9 points on Day 1 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start15 Jun 2020
- Primary completion28 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peking Union Medical College Hospital, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400201
- Sponsor's protocol ID
- HR-RMZL-Ⅲ-FB
- Status last verified
- May 2020
- First submitted
- 14 May 2020
- Last updated
- 22 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Study Evaluating the Efficacy and Safety of Remimazolam Tosilate Compared to Propofol in Patients Undergoing Bronchoscopy
- ClinicalTrials.gov ID
- NCT04400201
- Acronym / sponsor ID
- HR-RMZL-Ⅲ-FB
- Conditions
- Sedation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 28 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 22 May 2020 (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.
A multicenter, randomized, single-blind, active controlled, parallel group study comparing remimazolam tosilate to propofol in patients undergoing bronchoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam Tosilate | Experimental | Drug: Remimazolam Tosilate |
| Propofol | Active comparator | Drug: Propofol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18~80 years, female or male
- Patients scheduled for an bronchoscopy procedure
- 18 kg/m2<BMI<30kg/m2
- Patients understand clearly and participate in the study voluntarily, and sign the informed consent
Key exclusion criteria (7 listed)
- Patients scheduled for emergency surgery
- Patients with a history of drug abuse and / or alcohol abuse 2 years prior to the screening period
- One or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
- Pregnant women or those in lactation period
- Allergic to drugs used in the study
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 TosilateIntravenous injection at a dose of 0.3mg/kg for sedation induction and continuous intravenous infusion at an initiative dose of 1 mg/kg/h for sedation maintenance. | Drug | Remimazolam Tosilate |
| PropofolIntravenous injection at a dose of 1.5~2.5mg/kg for sedation induction and continuous intravenous infusion at the dose of 0~12 mg/kg/h for sedation maintenance | Drug | Propofol |
Primary outcome
Percentage (%) of participants who experienced successful sedation in undergoing bronchoscopy in each group
Time frame: From the onset of administration of the study drug to removal of bronchoscope on Day 1 of treatment
3 secondary outcomes
Time from start of investigational medicinal product administration to loss of consciousness
Time frame: From the onset of administration of the study drug to unconsciousness on Day 1 of treatment
Time from stop of investigational medicinal product to MOAA/S Score=5
Time frame: From the last dose of study drug until the patient has recovered to fully alert on Day 1 of treatment
Time from stop of investigational medicinal product to Aldrete Score≥9
Time frame: From the end of administration of the study drug until the patient reaches the modified Aldrete's system score of ≥9 points on Day 1 of treatment
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 22 Aug 2022.
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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.
Peking Union Medical College Hospital principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remimazolam Tosilate and Propofol in people with 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 4 inclusion and 7 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 22 Aug 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percentage (%) of participants who experienced successful sedation in undergoing bronchoscopy in each group (time frame: From the onset of administration of the study drug to removal of bronchoscope on Day 1 of treatment). 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 Aug 2022.