General AnesthesiaPhase 2NCT02406872
A Study Comparing Remimazolam Tosilate and Propofol for Intravenous General Anaesthesia in Operations
A Phase 2 study testing Remimazolam Tosilate and Propofol in people with General Anesthesia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as an intravenous general anaesthetic drug in operations and to determine its efficacy and safety profile comparing to propofol. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- General Anesthesia
- 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
- 144 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Aug 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- subjects aged 18-60 years；
- intending to have non-emergency operations；
- ASA( American Society of Anesthesiologists) I or II；
- 18 kg/m²<BMI(Body Mass Index)<30 kg/m².
Who cannot join
- people with contraindications to general anaesthesia;
- one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
- history of recent use of narcotics,analgesics,anaesthetics and benzodiazepine hypnotics;
- history of severe cardiovascular disease;
- uncontrolled blood glucose level;
- cerebral disease or mental disorder;
- allergic to drugs used in the study;
- pregnant women or those in lactation period.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as an intravenous general anaesthetic drug in operations and to determine its efficacy and safety profile comparing to propofol.
Read the detailed description
This is an multi-center，double-blinded，parallel and control study using Remimazolam or propofol for anesthesia in operations.Subjects are randomized to different treatment groups (including 3 for Remimazolam Tosilate and 1 for propofol) and anaesthetics are pumped contimuously into bodies.Analgesics and muscle relaxants are permitted during operations.Efficacy，safety and pharmacokinetic/pharmacodynamic profiles of Remimazolam Tosilate are to be evaluated.
- Conditions
- General Anesthesia
- Being tested
- Remimazolam Tosilate, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam TosilateDrug
IV pumping for anesthesia
PropofolDrug
IV bolus for anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam Tosilate 1 | Experimental | IV pumping of Remimazolam Tosilate at 6mg/kg/h for anesthesia induction Receives: Drug: Remimazolam Tosilate |
| Remimazolam Tosilate 2 | Experimental | intravenous pumping of Remimazolam Tosilate at 12mg/kg/h for anesthesia induction Receives: Drug: Remimazolam Tosilate |
| Remimazolam Tosilate 3 | Experimental | intravenous pumping of Remimazolam Tosilate at 18mg/kg/h for anesthesia induction Receives: Drug: Remimazolam Tosilate |
| Propofol | Active comparator | single IV bolus of Propofol at 2.0-2.5mg/kg for anesthesia induction Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful anaesthesia rate as measured by the proportion of subjects who experienced succesful anesthesia during operations
Measured: an average of 3 hours (immediately after opaerations)
Secondary outcomes (3)
bispectral index(BIS) during anaesthesia as measured by bispectral index machine
Measured: every 5 minutes
recovery time as measured by time
Measured: an average of 3 hours (after cessation of anesthetics pumping)
induction time as measured by time
Measured: 1-10 minutes (from the begining of anesthetics)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startDec 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 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
- NCT02406872
- Sponsor's protocol ID
- HR7056-002
- Status last verified
- Dec 2015
- First submitted
- 15 Feb 2015
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing Remimazolam Tosilate and Propofol for Intravenous General Anaesthesia in Operations
- ClinicalTrials.gov ID
- NCT02406872
- Acronym / sponsor ID
- HR7056-002
- Conditions
- General Anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 2 Apr 2015 (estimated)
- 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 find out the optimal dose for Remimazolam Tosilate as an intravenous general anaesthetic drug in operations and to determine its efficacy and safety profile comparing to propofol.
Detailed description
This is an multi-center，double-blinded，parallel and control study using Remimazolam or propofol for anesthesia in operations.Subjects are randomized to different treatment groups (including 3 for Remimazolam Tosilate and 1 for propofol) and anaesthetics are pumped contimuously into bodies.Analgesics and muscle relaxants are permitted during operations.Efficacy，safety and pharmacokinetic/pharmacodynamic profiles of Remimazolam Tosilate are to be evaluated.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Remimazolam Tosilate 1 | Experimental | Drug: Remimazolam TosilateIV pumping of Remimazolam Tosilate at 6mg/kg/h for anesthesia induction |
| Remimazolam Tosilate 2 | Experimental | Drug: Remimazolam Tosilateintravenous pumping of Remimazolam Tosilate at 12mg/kg/h for anesthesia induction |
| Remimazolam Tosilate 3 | Experimental | Drug: Remimazolam Tosilateintravenous pumping of Remimazolam Tosilate at 18mg/kg/h for anesthesia induction |
| Propofol | Active comparator | Drug: Propofolsingle IV bolus of Propofol at 2.0-2.5mg/kg for anesthesia induction |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- subjects aged 18-60 years；
- intending to have non-emergency operations；
- ASA( American Society of Anesthesiologists) I or II；
- 18 kg/m²<BMI(Body Mass Index)<30 kg/m².
Key exclusion criteria (8 listed)
- people with contraindications to general anaesthesia;
- one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
- history of recent use of narcotics,analgesics,anaesthetics and benzodiazepine hypnotics;
- history of severe cardiovascular disease;
- uncontrolled blood glucose level;
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 TosilateIV pumping for anesthesia | Drug | Remimazolam Tosilate 1, Remimazolam Tosilate 2, Remimazolam Tosilate 3 |
| PropofolIV bolus for anesthesia | Drug | Propofol |
Primary outcome
successful anaesthesia rate as measured by the proportion of subjects who experienced succesful anesthesia during operations
Time frame: an average of 3 hours (immediately after opaerations)
3 secondary outcomes
bispectral index(BIS) during anaesthesia as measured by bispectral index machine
Time frame: every 5 minutes
recovery time as measured by time
Time frame: an average of 3 hours (after cessation of anesthetics pumping)
induction time as measured by time
Time frame: 1-10 minutes (from the begining of anesthetics)
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 31 Dec 2015.
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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 2 study testing Remimazolam Tosilate and Propofol in people with General Anesthesia, 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 8 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 31 Dec 2015. 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?
successful anaesthesia rate as measured by the proportion of subjects who experienced succesful anesthesia during operations (time frame: an average of 3 hours (immediately after opaerations)). 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 31 Dec 2015.