Critical IllnessPhase 2NCT04790734
Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients
A Phase 2 study testing Sedation drugs in people with Critical Illness, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of remimazolam compared to propofol for sedation in mechanically ventilated ICU patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Sedation drugs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2021to 12 May 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 75 years;
- Intubated and mechanically ventilated ≤96 hours before enrollment；
- Expected to require continuous invasive ventilation and sedation ≥24 hours;
- Requirement for light to moderate sedation (a RASS score of -3 to 0).
Who cannot join
- Body mass index (BMI) <18 or >30 kg/m2;
- Acute severe neurological disorder and any other condition interfering with RASS assessment;
- Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors;
- Heart rate less than 50 beats/min;
- Second- or third-degree heart block in the absence of a pacemaker;
- Unstable angina;
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- Acute myocardial infarction;
- Left ventricular ejection fraction less than 30%;
- Contraindicate or allergic to study drugs;
- Moribund state;
- Acute hepatitis or serious hepatic dysfunction (Child-Pugh class C);
- Chronic kidney disease with glomerular filtration rate (GFR) < 60 ml/min/1.73m2;
- Alcohol abuse;
- Myasthenia gravis;
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
About this study
Official title: Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients: a Pilot Study
The purpose of this study is to evaluate the efficacy and safety of remimazolam compared to propofol for sedation in mechanically ventilated ICU patients.
Read the detailed description
This is a single-center, prospective, randomized, controlled pilot study using remimazolam and propofol for sedation in mechanically ventilated ICU patients. Subjects are randomized to remimazolam group and propofol group in a 1:1 ratio. Remifentanil is administered as the analgesic. Efficacy and safety profiles of remimazolam besylate are to be evaluated.
- Conditions
- Critical Illness
- Being tested
- Sedation drugs
- Keywords
- Remimazolam besylate, Propofol, Intensive care unit, Mechanical ventilation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation drugsDrug
Different sedation drugs
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam | Experimental | Patients in the remimazolam group received remimazolam besylate at an initial infusion rate of 0.15 mg/kg/h and adjusted to maintain a RASS score of -3 to 0. Receives: Drug: Sedation drugs |
| Propofol | Active comparator | Patients in the propofol group received propofol at an initial infusion rate of 2.0 mg/kg/h and adjusted to maintain a RASS score of -3 to 0. Receives: Drug: Sedation drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of time in the target sedation range without rescue sedation
The percentage of time in the target sedation range without rescue sedation
Measured: From the beginning of using study sedatives until being extubated, being discharged from our ICU, the study drug was stopped for 24 hours by physicians, or 7 days after enrollment, whichever came first
Secondary outcomes (3)
Length of ICU stay
Length of ICU stay
Measured: From start of study to 28 days
28-day mortality
28-day mortality
Measured: From start of study to 28 days
7-day ventitlator free time
7-day ventitlator free time
Measured: From start of study to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start10 May 2021
- Primary completion12 Apr 2022
- Study completion12 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaobo Yang, MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- You Shang, Professor, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790734
- Sponsor's protocol ID
- WUHICU202101
- Status last verified
- Sep 2022
- First submitted
- 8 Mar 2021
- Last updated
- 15 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients: a Pilot Study
- ClinicalTrials.gov ID
- NCT04790734
- Acronym / sponsor ID
- WUHICU202101
- Conditions
- Critical Illness
- Keywords
- Remimazolam besylate, Propofol, Intensive care unit, Mechanical ventilation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 12 Apr 2022 (actual)
- Study completion
- 12 May 2022 (actual)
- First posted
- 10 Mar 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.
The purpose of this study is to evaluate the efficacy and safety of remimazolam compared to propofol for sedation in mechanically ventilated ICU patients.
Detailed description
This is a single-center, prospective, randomized, controlled pilot study using remimazolam and propofol for sedation in mechanically ventilated ICU patients. Subjects are randomized to remimazolam group and propofol group in a 1:1 ratio. Remifentanil is administered as the analgesic. Efficacy and safety profiles of remimazolam besylate are to be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | Experimental | Drug: Sedation drugsPatients in the remimazolam group received remimazolam besylate at an initial infusion rate of 0.15 mg/kg/h and adjusted to maintain a RASS score of -3 to 0. |
| Propofol | Active comparator | Drug: Sedation drugsPatients in the propofol group received propofol at an initial infusion rate of 2.0 mg/kg/h and adjusted to maintain a RASS score of -3 to 0. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 and ≤ 75 years;
- Intubated and mechanically ventilated ≤96 hours before enrollment；
- Expected to require continuous invasive ventilation and sedation ≥24 hours;
- Requirement for light to moderate sedation (a RASS score of -3 to 0).
Key exclusion criteria (15 listed)
- Body mass index (BMI) <18 or >30 kg/m2;
- Acute severe neurological disorder and any other condition interfering with RASS assessment;
- Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors;
- Heart rate less than 50 beats/min;
- Second- or third-degree heart block in the absence of a pacemaker;
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 |
|---|---|---|
| Sedation drugsDifferent sedation drugs | Drug | Propofol, Remimazolam |
Primary outcome
The percentage of time in the target sedation range without rescue sedation
Time frame: From the beginning of using study sedatives until being extubated, being discharged from our ICU, the study drug was stopped for 24 hours by physicians, or 7 days after enrollment, whichever came first
The percentage of time in the target sedation range without rescue sedation
3 secondary outcomes
Length of ICU stay
Time frame: From start of study to 28 days
28-day mortality
Time frame: From start of study to 28 days
7-day ventitlator free time
Time frame: From start of study to 7 days
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 15 Sep 2022.
- Individual participant dataSharing planned: No
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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.
You Shang, Professor principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 Sedation drugs in people with Critical Illness, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 15 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 15 Sep 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 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 percentage of time in the target sedation range without rescue sedation (time frame: From the beginning of using study sedatives until being extubated, being discharged from our ICU, the study drug was stopped for 24 hours by physicians, or 7 days after enrollment, whichever came first). 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 15 Sep 2022.