AnalgesiaPhase 3NCT04947345
The Availability and Safety Study of Remimazolam Besylate for Injection on Sedation of ERAS Patients
A Phase 3 study testing Remimazolam Besylate and Propofol in people with Analgesia and Postoperative Pain, run by Peking Union Medical College Hospital.
Trial summary
This trial intends to evaluate Remimazolam Besylate's availability and safety compared with propofol. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Analgesia, Postoperative Pain
- What is being tested?
- Remimazolam Besylate and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Sep 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet criteria of enhanced recovery after surgery (ERAS);
- Mechanical ventilated when enrolled and have estimation of more than 10 hours of mechanical ventilation in ICU
- Aged between 18-75 years old AND 18kg/m2 ≤ BMI ≤ 30 kg/m2;
- Clearly know the purpose and objective of this clinical study and voluntarily enrolled.
- Criteria of ERAS: (1) without dysfunction of nervous system or Glasgow Coma Score > 12; (2) a satisfied glucose level (random blood glucose<11.1mmol/L during screening stage) for diabetes mellitus patients; (3) Without acute coronary syndrome in recent 6 months; (4) Without bradycardia and third-degree atrioventricular block (except for patients with pacemaker) during screening stage; (5) systolic blood pressure>90mmHg with no usage of vasoactive agent during screening stage; (6) without mental illness (schizophrenia, depressive disorder), cognitive dysfunction (identified by MMSE), epilepsy, history of abuse of psychotropic or anesthesia medication; (7) without disorder of coagulation function (PT/INR/APTT > 1.5×upper limit), bleeding tendency (active peptic ulcer), under treatment of thrombolysis and anticoagulant; (8) without disorder of liver function (ALT/AST > 2×upper limit and total bilirubin>1.5×upper limit); (9) without disorder of renal function (Creatine or BUN/Urea>1.5×upper limit); without dialysis patients.
Who cannot join
- Allergy to component of Remimazolam besylate for injection;
- Woman in gestation and lactation period;
- Enrolled in other clinical trails in recent 3 months;
- Other circumstance that identified by researchers that do not suitable for this clinical trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Availability and Safety Study of Remimazolam Besylate for Injection on Sedation of ERAS Patients Under Mechanical Ventilation in ICU: Protocol for a Randomized, Open-label, Controlled Trial
This trial intends to evaluate Remimazolam Besylate's availability and safety compared with propofol.
- Conditions
- Analgesia, Postoperative Pain
- Being tested
- Remimazolam Besylate, Propofol
- Keywords
- sedative, Remimazolam Besylate, postoperative sedation
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam BesylateDrug
Remimazolam Besylate are used as sedatives for subjects in this arm.
PropofolDrug
Propofol are used as sedatives for subjects in this arm.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: Remimazolam Besylate | Experimental | Patients should be given study drugs as soon as possible after entering the ICU. Syringe pump is used to administer medication. Loading dose of Remimazolam is 0.2 mg/kg, which is administered for less than 1 min initially. Maintaining dose is 0.2-1 mg/kg/h. Sedative target is RASS between 0 and -2 points. Excepts for fentanyl and Remimazolam, no analgesic or sedative could be used during the experimental time period. Receives: Drug: Remimazolam Besylate |
| Positive control group: Propofol | Active comparator | Patients should be given study drugs as soon as possible after entering the ICU. Syringe pump is used to administer medication. Loading dose of propofol is 0.2 mg/kg, which is administered for less than 1 min initially. Maintaining dose is 0.3-4.0 mg/kg/h. Sedative target is RASS between 0 and -2 points. Excepts for fentanyl and propofol, no analgesic or sedative could be used during the experimental time period.
Rescue therapy for experimental group During the treatment of the experimental group, if the RASS cannot be maintained at 0 to -2 points at the maximum Remimazolam maintenance dose of 1 mg/kg/h, a loading dose of propofol (0.2 mg/kg) can be given intravenously. If RASS fails to satisfied after three loading doses of propofol, Remimazolam is discarded and 0.3-4.0 mg/kg/h of propofol are used as rescue therapy for experimental group. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction rate of sedation
(number of subjects that meets satisfied RASS score under prescribed dose of sedative agents during study / total number of subjects) ×100%
Measured: 24 hours since injection of sedatives
Rate of major clinical events
(number of subjects that suffer from major clinical events during study / total number of subjects) ×100%. Major clinical events are defined as cardiac arrest, malignant arrhythmia, new onset of shock, new onset of sepsis and respirate failure unrelated to primary illness.
Measured: 48 hours since injection of sedatives
Secondary outcomes (5)
incidence of delirium
(subjects with delirium / total number of subjects ×100%) by 12h and 24h after entering ICU
Measured: 48 hours since injection of sedatives
Time to weaning and extubation
Time to weaning and extubation
Measured: 48 hours since injection of sedatives
Difficulty of nursing
By Barthel index assessment
Measured: 48 hours since injection of sedatives
28-days survival
(number of subjects that alive in 28-days since ICU entry/ total number of subjects) ×100%
Measured: 28 days since injection of sedatives
incidence of rescue therapy in experimental group
(number of subjects that receive rescue therapy in experimental group/ total number of subjects) ×100%
Measured: 24 hours since injection of sedatives
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yichang Humanwell Pharmaceutical Co., Ltd., China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947345
- Sponsor's protocol ID
- 20-JS-2814
- Status last verified
- Jun 2021
- First submitted
- 14 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: So far, we haven't decide if individual participant data are suitable to share with other researchers.
Publications
Liu S, Su L, Zhang B, He H, Li Z, Li Q, Wang Q, Smith F, Long Y. The Availability and Safety Study of Remimazolam Besylate for Injection on Sedation of ERAS Patients Under Mechanical Ventilation in ICU: Protocol for a Randomized, Open-Label, Controlled Trial. Front Med (Lausanne). 2021 Nov 5;8:735473. doi: 10.3389/fmed.2021.735473. eCollection 2021.
PubMed 34805204
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Availability and Safety Study of Remimazolam Besylate for Injection on Sedation of ERAS Patients Under Mechanical Ventilation in ICU: Protocol for a Randomized, Open-label, Controlled Trial
- ClinicalTrials.gov ID
- NCT04947345
- Acronym / sponsor ID
- 20-JS-2814
- Conditions
- Analgesia, Postoperative Pain
- Keywords
- sedative, Remimazolam Besylate, postoperative sedation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Yichang Humanwell Pharmaceutical Co., Ltd., China
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 1 Jul 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.
This trial intends to evaluate Remimazolam Besylate's availability and safety compared with propofol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: Remimazolam Besylate | Experimental | Drug: Remimazolam BesylatePatients should be given study drugs as soon as possible after entering the ICU. Syringe pump is used to administer medication. Loading dose of Remimazolam is 0.2 mg/kg, which is administered for less than 1 min initially. Maintaining dose is 0.2-1 mg/kg/h. Sedative target is RASS between 0 and -2 points. Excepts for fentanyl and Remimazolam, no analgesic or sedative could be used during the experimental time period. |
| Positive control group: Propofol | Active comparator | Drug: PropofolPatients should be given study drugs as soon as possible after entering the ICU. Syringe pump is used to administer medication. Loading dose of propofol is 0.2 mg/kg, which is administered for less than 1 min initially. Maintaining dose is 0.3-4.0 mg/kg/h. Sedative target is RASS between 0 and -2 points. Excepts for fentanyl and propofol, no analgesic or sedative could be used during the experimental time period. Rescue therapy for experimental group During the treatment of the experimental group, if the RASS cannot be maintained at 0 to -2 points at the maximum Remimazolam maintenance dose of 1 mg/kg/h, a loading dose of propofol (0.2 mg/kg) can be given intravenously. If RASS fails to satisfied after three loading doses of propofol, Remimazolam is discarded and 0.3-4.0 mg/kg/h of propofol are used as rescue therapy for experimental group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meet criteria of enhanced recovery after surgery (ERAS);
- Mechanical ventilated when enrolled and have estimation of more than 10 hours of mechanical ventilation in ICU
- Aged between 18-75 years old AND 18kg/m2 ≤ BMI ≤ 30 kg/m2;
- Clearly know the purpose and objective of this clinical study and voluntarily enrolled.
- Criteria of ERAS: (1) without dysfunction of nervous system or Glasgow Coma Score > 12; (2) a satisfied glucose level (random blood glucose<11.1mmol/L during screening stage) for diabetes mellitus patients; (3) Without acute coronary syndrome in recent 6 months; (4) Without bradycardia and third-degree atrioventricular block (except for patients with pacemaker) during screening stage; (5) systolic blood pressure>90mmHg with no usage of vasoactive agent during screening stage; (6) without mental illness (schizophrenia, depressive disorder), cognitive dysfunction (identified by MMSE), epilepsy, history of abuse of psychotropic or anesthesia medication; (7) without disorder of coagulation function (PT/INR/APTT > 1.5×upper limit), bleeding tendency (active peptic ulcer), under treatment of thrombolysis and anticoagulant; (8) without disorder of liver function (ALT/AST > 2×upper limit and total bilirubin>1.5×upper limit); (9) without disorder of renal function (Creatine or BUN/Urea>1.5×upper limit); without dialysis patients.
Key exclusion criteria (4 listed)
- Allergy to component of Remimazolam besylate for injection;
- Woman in gestation and lactation period;
- Enrolled in other clinical trails in recent 3 months;
- Other circumstance that identified by researchers that do not suitable for this clinical trial.
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 BesylateRemimazolam Besylate are used as sedatives for subjects in this arm. | Drug | Experimental group: Remimazolam Besylate |
| PropofolPropofol are used as sedatives for subjects in this arm. | Drug | Positive control group: Propofol |
Primary outcome
Satisfaction rate of sedation
Time frame: 24 hours since injection of sedatives
(number of subjects that meets satisfied RASS score under prescribed dose of sedative agents during study / total number of subjects) ×100%
Rate of major clinical events
Time frame: 48 hours since injection of sedatives
(number of subjects that suffer from major clinical events during study / total number of subjects) ×100%. Major clinical events are defined as cardiac arrest, malignant arrhythmia, new onset of shock, new onset of sepsis and respirate failure unrelated to primary illness.
5 secondary outcomes
incidence of delirium
Time frame: 48 hours since injection of sedatives
Time to weaning and extubation
Time frame: 48 hours since injection of sedatives
Difficulty of nursing
Time frame: 48 hours since injection of sedatives
28-days survival
Time frame: 28 days since injection of sedatives
incidence of rescue therapy in experimental group
Time frame: 24 hours since injection of sedatives
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Derived from this study: PubMed 34805204Liu S, Su L, Zhang B, He H, Li Z, Li Q, Wang Q, Smith F, Long Y. The Availability and Safety Study of Remimazolam Besylate for Injection on Sedation of ERAS Patients Under Mechanical Ventilation in ICU: Protocol for a Randomized, Open-Label, Controlled Trial. Front Med (Lausanne). 2021 Nov 5;8:735473. doi: 10.3389/fmed.2021.735473. eCollection 2021.
- Individual participant dataSharing planned: Undecided. So far, we haven't decide if individual participant data are suitable to share with other researchers.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remimazolam Besylate and Propofol in people with Analgesia and Postoperative Pain, run by Peking Union Medical College Hospital.
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 4 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 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Longxiang Su, M.D. (+8615652797257, slx77@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction rate of sedation (time frame: 24 hours since injection of sedatives). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04947345, which also lists 1 linked publication.
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 1 Jul 2021.