Sedation and AnalgesiaNCT05160987
Effect of Remimazolam With Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared With Midazolam
A study testing Remimazolam and Midazolam in people with Sedation and Analgesia, run by Zhujiang Hospital at 1 site in China.
Trial summary
In this parallel, multicenter, single-blind randomized controlled trial, mechanical ventilated patients will be randomly assigned to two groups. One receives remimazolam to achieve sedation goals, while the other receives Midazolam. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sedation and Analgesia
- What is being tested?
- Remimazolam and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Critical ill patients that are mechanically ventilated within the first 48h of admission to the ICU and who would remain in the ICU for over 72h were enrolled in this study.
- Age 18-80 years.
- Voluntary informed consent.
Who cannot join
- Surgical treatment is performed within 24 hours.
- Craniocerebral injury, post neurosurgery, non drug coma, mental illness or peripheral neuropathy.
- Heart rates are less than 50 beats / min or severe atrioventricular block without pacemaker support.
- The mean arterial pressure is less than 55 mmHg even though fluids and vasoactive drugs are administrated.
- Patients who are known or suspected allergy to benzodiazepines, propofol, dexmedetomidine or opioids.
- History of alcohol and drug abuse.
- End stages of lung diseases, such as pulmonary fibrosis, lung damage, etc.
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University
Guangzhou, Guangdong, 510282
Ping Chang, M.D.PhD, +86-2062782927, changp963@163.com
About this study
Official title: Effect of Remimazolam With Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared With Midazolam - A Parallel, Multicenter, Single-blind Randomized Controlled Trial
In this parallel, multicenter, single-blind randomized controlled trial, mechanical ventilated patients will be randomly assigned to two groups. One receives remimazolam to achieve sedation goals, while the other receives Midazolam. The primary outcome is the effect of remimazolam on duration of mechanical ventilated of critical patients compared to midazolam.
Read the detailed description
Investigational drug#remimazolam for injection Study title#Effect of Remimazolam with Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared with Midazolam - A parallel, Multicenter, Single-blind Randomized Controlled Trial Principal Investigator#Professor Zhanguo Liu, Dr.Jing Cai, Department of Critical Care Unit, Zhujiang Hospital, Southern Medical University Study subjects#Critical ill patients that are mechanically ventilated within the first 48h of admission to the ICU and who would remain in the ICU for over 72h are enrolled in this study. The ages of patients should be in the range from 18 to 80.
Study phase# Investigator Initiated Trial(IIT) Study objectives#The objective of the study is to determine whether remimazolam, compared with midazolam, reduces duration of ventilation in severe patients.
Study design#A parallel, Multicenter, Single-blind Randomized Controlled Trial. Medication method#Remimazolam group#Patients are administered with a bolus of remimazolam with 0.1-0.3mg/kg intravenously in 1 minute for the first time. And the maintenance dose is 0.25-0.1mg/kg/h, meanwhile the dose of remimazolam should be titrated according to Richmond Agitation Sedation Scale (RASS) scores. Nonbenzodiazepines could be administrated to the patients if sedation targets were not achieved.
Midazolam group#Patients are administered with a bolus of midazolam with 0.01-0.05mg/kg intravenously in 1 minute for the first time. And maintenance dose is 0.02-0.1mg/kg/h, meanwhile the dose of midazolam should be titrated according to Richmond Agitation Sedation Scale (RASS) scores. Nonbenzodiazepines could be administrated to the patients if sedation targets were not achieved.
Spontaneous breathing test (SBT) is conducted daily while patients are stable. Weaning would be considered after a successful SBT, and the sedation for study need to be stopped subsequently. If the weaning failed, mechanical ventilation and sedation would be used immediately according to sedation targets. Weaning success is defined as the ability to successfully complete the SBT and sustain spontaneous breathing for 48h after extubation.
Course#28days Sample size#440. Sites#15 Primary endpoint#Duration of mechanical ventilation(weaning success is typically regarded as consecutive ventilator-free over 24h following liberation from a ventilator. The duration of mechanical ventilation is from the enrollment time to the weaning time. The study and observation would be stopped due to difficult ventilator weaning, which features weaning failure repeatedly for 3 weeks.) Secondary endpoints#
- Duration of endotracheal intubation(calculated from the time of enrollment);
- Completion rate of sedation goals (completion rate of sedation goal = days of achieving sedation goals / total days of sedation (days from enrollment to successful ventilator withdrawal) × 100%）)；
- Sedation remediation is defined as requiring combination with other nonbenzodiazepines sedations.
- Length of stay in ICU and total length of stay (time from admission to discharge);
- Others: anterograde amnesia, 28 day mortality, total cost of sedative drugs in ICU, hospitalization expenses in ICU; Anterograde amnesia used a questionnaire that is record to assess the patient's forgetfulness.
Safety endpoints#
- Incidence of Hypotension(20% fall in systolic pressure).
- Incidence of Delirium.
- Incidence of spontaneous extubation.
- Incidence of reintubation in 12h or tracheotomy.
- Incidence of Myasthenia.(following weaning from ventilations)
- Incidence of thrombus.(lower extremity deep venous thrombosis)
- Conditions
- Sedation and Analgesia
- Being tested
- Remimazolam, Midazolam
- Keywords
- Remimazolam, Midazolam, duration of mechanical ventilation, Sedation
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Remimazolam will be diluted with 0.9% saline to ensure that the therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs.
MidazolamDrug
Midazolam will be diluted with 0.9% saline to ensure that the therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam Group | Experimental | The patients are administered with sedation of remimazolam and analgesia of remifentanil on the basis of routine treatment. If the patient does not receive sedative drug before enrollment, patient would be administered with a bolus of remimazolam with 0.1-0.3mg/kg intravenously in 1 minute for the first time. And maintenance dose is 0.25-0.1mg/kg/h, meanwhile the dose of remimazolam should be titrated according to RASS scores. Nonbenzodiazepines could be administrated to the patients if sedation targets were not achieved, and the medication and dosage is recorded. Receives: Drug: Remimazolam |
| Midazolam Group | Placebo comparator | The patients are administered with sedation of midazolam analgesia of remifentanil on the basis of routine treatment. If the patient does not receive sedative drugs before enrollment, patients would be administered with a bolus of midazolam with 0.01-0.05mg/kg intravenously in 1 minute for the first time. And the maintenance dose is 0.02-0.1mg/kg/h, meanwhile the dose of midazolam should be titrated according to RASS scores. Nonbenzodiazepines could be administrated to the patients if sedation targets were not achieved, and the medication and dosage is recorded. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of mechanical ventilation
Weaning success is typically regarded as consecutive ventilator-free over 24h following liberation from a ventilator. The duration of mechanical ventilation is from the enrollment time to the weaning time.
The study and observation would be stopped due to difficult ventilator weaning, which features weaning failure repeatedly for 3 weeks.
Measured: From the date of enrollment until the date of successful ventilator withdrawal, assessed up to 28 days
Secondary outcomes (6)
Duration of endotracheal intubation
Duration of endotracheal intubation
Measured: From the date of enrollment until the date of pulling out the endotracheal tube, assessed up to 28 days
Completion rate of sedation goal
completion rate of sedation goal = days of achieving sedation goals / total days of sedation (days from enrollment to successful ventilator withdrawal) × 100%
Measured: From the date of enrollment until the date of successful ventilator withdrawal, assessed up to 28 days
Remediation is defined as requiring combination with other sedations
If the sedation goal cannot be reached, the clinician will use non benzodiazepines according to the actual situation of the patient, and record the medication and dosage.
Measured: From the date of enrollment until the date of successful ventilator withdrawal, assessed up to 28 days
Length of stay in ICU and total length of stay
Length of stay in ICU and total length of stay
Measured: From the date of admission in ICU until the date of transfer from ICU
Anterograde amnesia
Anterograde amnesia used a questionnaire to record their memories of related events during mechanical ventilation (turning over, sputum suction, vascular catheterization, nocturnal nursing medication and other invasive operations). Assess the patient's forgetfulness.
Measured: From the date of enrollment until the date of successful ventilator withdrawal
28 day mortality
28 day mortality
Measured: From the date of enrollment until the date of death from any cause, assessed up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start29 Mar 2022
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation and AnalgesiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants in remimazolam group receive intravenous remimazolam. The participants in midazolam group receive midazolam.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Integrated traditional Chinese and Western Medicine Hospital of Southern Medical University, First Affiliated Hospital of Shantou University Medical College, Affiliated Hospital of Guangdong Medical University, Yunfu People's Hospital, Zhongshan Hospital Of Traditional Chinese Medicine, Guangdong Province Traditional Medical hospital, The Third Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Principal investigator, Liu Zhanguo, Zhujiang Hospital
- Investigators
- Zhanguo Liu, M.D.PhD, Principal investigator, Department of Critical Care Medicine of Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160987
- Sponsor's protocol ID
- 2021-KY-089-02
- Status last verified
- Apr 2026
- First submitted
- 29 Nov 2021
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since some data may involve patients privacy. We have no plans to share data so far, and some data may be shared later depending on the patient's wishes.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remimazolam With Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared With Midazolam - A Parallel, Multicenter, Single-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05160987
- Acronym / sponsor ID
- 2021-KY-089-02
- Conditions
- Sedation and Analgesia
- Keywords
- Remimazolam, Midazolam, duration of mechanical ventilation, Sedation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Integrated traditional Chinese and Western Medicine Hospital of Southern Medical University, First Affiliated Hospital of Shantou University Medical College, Affiliated Hospital of Guangdong Medical University, Yunfu People's Hospital, Zhongshan Hospital Of Traditional Chinese Medicine, Guangdong Province Traditional Medical hospital, The Third Affiliated Hospital of Guangzhou Medical University
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Dec 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.
In this parallel, multicenter, single-blind randomized controlled trial, mechanical ventilated patients will be randomly assigned to two groups. One receives remimazolam to achieve sedation goals, while the other receives Midazolam. The primary outcome is the effect of remimazolam on duration of mechanical ventilated of critical patients compared to midazolam.
Detailed description
Investigational drug#remimazolam for injection Study title#Effect of Remimazolam with Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared with Midazolam - A parallel, Multicenter, Single-blind Randomized Controlled Trial Principal Investigator#Professor Zhanguo Liu, Dr.Jing Cai, Department of Critical Care Unit, Zhujiang Hospital, Southern Medical University Study subjects#Critical ill patients that are mechanically ventilated within the first 48h of admission to the ICU and who would remain in the ICU for over 72h are enrolled in this study. The ages of patients should be in the range from 18 to 80.
Study phase# Investigator Initiated Trial(IIT) Study objectives#The objective of the study is to determine whether remimazolam, compared with midazolam, reduces duration of ventilation in severe patients.
Study design#A parallel, Multicenter, Single-blind Randomized Controlled Trial. Medication method#Remimazolam group#Patients are administered with a bolus of remimazolam with 0.1-0.3mg/kg intravenously in 1 minute for the first time. And the maintenance dose is 0.25-0.1mg/kg/h, meanwhile the dose of remimazolam should be titrated according to Richmond Agitation Sedation Scale (RASS) scores. Nonbenzodiazepines could be administrated to the patients if sedation targets were not achieved.
Midazolam group#Patients are administered with a bolus of midazolam with 0.01-0.05mg/kg intravenously in 1 minute for the first time. And maintenance dose is 0.02-0.1mg/kg/h, meanwhile the dose of midazolam should be titrated according to Richmond Agitation Sedation Scale (RASS) scores. Nonbenzodiazepines could be administrated to the patients if sedation targets were not achieved.
Spontaneous breathing test (SBT) is conducted daily while patients are stable. Weaning would be considered after a successful SBT, and the sedation for study need to be stopped subsequently. If the weaning failed, mechanical ventilation and sedation would be used immediately according to sedation targets. Weaning success is defined as the ability to successfully complete the SBT and sustain spontaneous breathing for 48h after extubation.
Course#28days Sample size#440. Sites#15 Primary endpoint#Duration of mechanical ventilation(weaning success is typically regarded as consecutive ventilator-free over 24h following liberation from a ventilator. The duration of mechanical ventilation is from the enrollment time to the weaning time. The study and observation would be stopped due to difficult ventilator weaning, which features weaning failure repeatedly for 3 weeks.) Secondary endpoints#
- Duration of endotracheal intubation(calculated from the time of enrollment);
- Completion rate of sedation goals (completion rate of sedation goal = days of achieving sedation goals / total days of sedation (days from enrollment to successful ventilator withdrawal) × 100%）)；
- Sedation remediation is defined as requiring combination with other nonbenzodiazepines sedations.
- Length of stay in ICU and total length of stay (time from admission to discharge);
- Others: anterograde amnesia, 28 day mortality, total cost of sedative drugs in ICU, hospitalization expenses in ICU; Anterograde amnesia used a questionnaire that is record to assess the patient's forgetfulness.
Safety endpoints#
- Incidence of Hypotension(20% fall in systolic pressure).
- Incidence of Delirium.
- Incidence of spontaneous extubation.
- Incidence of reintubation in 12h or tracheotomy.
- Incidence of Myasthenia.(following weaning from ventilations)
- Incidence of thrombus.(lower extremity deep venous thrombosis)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The participants in remimazolam group receive intravenous remimazolam. The participants in midazolam group receive midazolam.
| Arm | Type | Receives |
|---|---|---|
| Remimazolam Group | Experimental | Drug: RemimazolamThe patients are administered with sedation of remimazolam and analgesia of remifentanil on the basis of routine treatment. If the patient does not receive sedative drug before enrollment, patient would be administered with a bolus of remimazolam with 0.1-0.3mg/kg intravenously in 1 minute for the first time. And maintenance dose is 0.25-0.1mg/kg/h, meanwhile the dose of remimazolam should be titrated according to RASS scores. Nonbenzodiazepines could be administrated to the patients if sedation targets were not achieved, and the medication and dosage is recorded. |
| Midazolam Group | Placebo comparator | Drug: MidazolamThe patients are administered with sedation of midazolam analgesia of remifentanil on the basis of routine treatment. If the patient does not receive sedative drugs before enrollment, patients would be administered with a bolus of midazolam with 0.01-0.05mg/kg intravenously in 1 minute for the first time. And the maintenance dose is 0.02-0.1mg/kg/h, meanwhile the dose of midazolam should be titrated according to RASS scores. Nonbenzodiazepines could be administrated to the patients if sedation targets were not achieved, and the medication and dosage is recorded. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Critical ill patients that are mechanically ventilated within the first 48h of admission to the ICU and who would remain in the ICU for over 72h were enrolled in this study.
- Age 18-80 years.
- Voluntary informed consent.
Key exclusion criteria (8 listed)
- Surgical treatment is performed within 24 hours.
- Craniocerebral injury, post neurosurgery, non drug coma, mental illness or peripheral neuropathy.
- Heart rates are less than 50 beats / min or severe atrioventricular block without pacemaker support.
- The mean arterial pressure is less than 55 mmHg even though fluids and vasoactive drugs are administrated.
- Patients who are known or suspected allergy to benzodiazepines, propofol, dexmedetomidine or opioids.
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 |
|---|---|---|
| RemimazolamRemimazolam will be diluted with 0.9% saline to ensure that the therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs. | Drug | Remimazolam Group |
| MidazolamMidazolam will be diluted with 0.9% saline to ensure that the therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs. | Drug | Midazolam Group |
Primary outcome
Duration of mechanical ventilation
Time frame: From the date of enrollment until the date of successful ventilator withdrawal, assessed up to 28 days
Weaning success is typically regarded as consecutive ventilator-free over 24h following liberation from a ventilator. The duration of mechanical ventilation is from the enrollment time to the weaning time. The study and observation would be stopped due to difficult ventilator weaning, which features weaning failure repeatedly for 3 weeks.
6 secondary outcomes
Duration of endotracheal intubation
Time frame: From the date of enrollment until the date of pulling out the endotracheal tube, assessed up to 28 days
Completion rate of sedation goal
Time frame: From the date of enrollment until the date of successful ventilator withdrawal, assessed up to 28 days
Remediation is defined as requiring combination with other sedations
Time frame: From the date of enrollment until the date of successful ventilator withdrawal, assessed up to 28 days
Length of stay in ICU and total length of stay
Time frame: From the date of admission in ICU until the date of transfer from ICU
Anterograde amnesia
Time frame: From the date of enrollment until the date of successful ventilator withdrawal
28 day mortality
Time frame: From the date of enrollment until the date of death from any cause, assessed up to 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No. Since some data may involve patients privacy. We have no plans to share data so far, and some data may be shared later depending on the patient's wishes.
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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.
Zhanguo Liu, M.D.PhD principal investigator
Department of Critical Care Medicine of Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam and Midazolam in people with Sedation and Analgesia, run by Zhujiang Hospital 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 3 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: looking for participants now, as of the sponsor's last update on 17 Apr 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Cai (+86-2062782927, caijing78@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of mechanical ventilation (time frame: From the date of enrollment until the date of successful ventilator withdrawal, assessed up to 28 days). 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 17 Apr 2026.