Effect of DrugPhase 4NCT06575530
Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation
A Phase 4 study testing Remimazolam Besylate and Dexmedetomidine Hydrochloride in people with Effect of Drug and Adverse Drug Event, run by Beijing Shijitan Hospital, Capital Medical University at 1 site in China.
Trial summary
A multi-center, prospective, randomized, double-blind, active-controlled, no-inferiority clinical trial conducted across 5 tertiary medical centers in China. The objective of this RCT is to evaluate the sedative efficacy and safety profile of remimazolam besylate compared with dexmedetomidine in patients requiring… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Effect of Drug, Adverse Drug Event, Mechanical Ventilation Complication
- What is being tested?
- Remimazolam Besylate and Dexmedetomidine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2025to 30 Jun 2026
- Phase
- Phase 4
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 and 64 years
- Scheduled to undergo elective non-cardiac surgery
- Planned for general anesthesia
- With or without combined regional nerve blockade
- Admitted to the ICU with endotracheal intubation post-surgery
- With an anticipated duration of postoperative mechanical ventilation greater than 24 hours
- Clinically requiring light sedation( target RASS score 0 to -2)
Who cannot join
- Undergoing intracranial surgery, or having a history of severe neurological or spinal cord diseases
- Pre-existing history of schizophrenia, epilepsy, or Parkinson's disease
- Inability to communicate preoperatively due to coma, severe dementia, or language barriers
- Preoperative .cardiac insufficiency or severe cardiac arrhythmias
- Severe hepatic impariment( Child-Pugh class C)
- Severe renal impariment
Show all 11Show fewer
- Preoperative( within 24 hours prior to surgery) or intraoperative administration of dexmedetomidine or remimazolam
- Pregnancy or lactation
- Participation in any clinical trial involving investigational drugs within 30 days prior to enrollment
- Any other conditions deemed by the investigators to render the patient unsuitable for study participation
- Refusal to provide written informed consent
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
Beijing Shijitan Hospital.CMU
Beijing, Beijing Municipality, 100038
About this study
Official title: Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation: A Randomized Controlled Trial
A multi-center, prospective, randomized, double-blind, active-controlled, no-inferiority clinical trial conducted across 5 tertiary medical centers in China. The objective of this RCT is to evaluate the sedative efficacy and safety profile of remimazolam besylate compared with dexmedetomidine in patients requiring mechanical ventilation following non-cardiac surgery. The study hypothesized that remimazolam besylate is non-inferior to dexmedetomidine regarding the primary efficacy outcome.
- Conditions
- Effect of Drug, Adverse Drug Event, Mechanical Ventilation Complication, Critical Illness, Surgery, Sedation
- Being tested
- Remimazolam Besylate, Dexmedetomidine Hydrochloride
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam BesylateDrug
patients will be sedated with remimazolam via intravenous pump on the day of ICU admission, the dosage will titrate with the depth of sedation evaluated with RASS. If the target sedation depth could not to achieved within the prespecified maximum dose range of remimazolam, a standardized rescue sedation protocol will intiated as follows: an intravenous bolus of propofol at 0.2mg/kg will administered. Sedation depth will evaluated 5 minutes post-injection. The identical dose of propofol bolus will repeated until the desired sedation depth is reached. Continuous propofol infusion will initiated after three consecutive bolus injections of propofol. The continuous propofol infusion rate will titrated within the range of 0.2 to 1.0 mg/kg/h until the satisfactory target sedation depth is established. At the subsequent hourly sedation assessment, continuous propofol infusion will discontinued once the patient successfully maintained a stable RASS score within the 0 to -2 range.
Dexmedetomidine HydrochlorideDrug
patients will be sedated with dexmedetomidine hydrochloride via intravenous pump on the day of ICU admission, the dosage will titrate with the depth of sedation evaluated with RASS. If the target sedation depth could not to achieved within the prespecified maximum dose range of remimazolam, a standardized rescue sedation protocol will intiated as follows: an intravenous bolus of propofol at 0.2mg/kg will administered. Sedation depth will evaluated 5 minutes post-injection. The identical dose of propofol bolus will repeated until the desired sedation depth is reached. Continuous propofol infusion will initiated after three consecutive bolus injections. The continuous propofol infusion rate will titrated within the range of 0.2 to 1.0 mg/kg/h until the satisfactory target sedation depth is established. At the subsequent hourly sedation assessment, continuous propofol infusion will discontinued once the patient successfully maintained a stable RASS score within the 0 to -2 range.
| Study group | Role | What they receive |
|---|---|---|
| remimazolam besylate group | Experimental | Upon ICU admission, remimazolam besylate infusion will initiated for light sedation maintenance at a dose range of 0.1 to1.0mg/Kg/h. The target sedation depth is defined as a RASS score of 0 to -2. The RASS score will evaluated and recorded hourly, and the infusion rate of remimazolam besylate will titrated( increased or decreased) accordingly to maintain the patient within the target sedation range. For multimodal analgesia, remifentanil will co-administered continuously at a dose of 0.1 to 0.5ug/Kg/min to ensure a CPOT score of 2 or less. Receives: Drug: Remimazolam Besylate |
| Dexmedetomidine hydrochloride group | Active comparator | Upon ICU admission, dexmedetomidine infusion will initiated for light sedation maintenance at a dose range of 0.2 to0.7ug/Kg/h. The target sedation depth is defined as a RASS score of 0 to -2. The RASS score will evaluated and recorded hourly, and the infusion rate of dexmedetomidine will titrated( increased or decreased) accordingly to maintain the patient within the target sedation range. For multimodal analgesia, remifentanil will co-administered continuously at a dose of 0.1 to 0.5ug/Kg/min to ensure a CPOT score of 2 or less. Receives: Drug: Dexmedetomidine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time in optimal sedation
Percentage of time in optimal sedation during sedation in the ICU, sedation depth is assessed using Richmond Agitation Sedation Scale(RASS, -5 to +4), target sedation must has a RASS score -2 to 0.
Measured: Through the useage of sedative drugs in the ICU, an average of 3 days
Secondary outcomes (15)
Ventilation free days
Ventilation free days(VFDs) at 28 days. VFDs=0 if subject dies within 28 days of mechaincal ventilation; VFDs=28-X if successfully liberated from ventilation X days after initiation，if the patient is reintubated within 28 days, "X" represents the days of the last extubation; VFDs=0 if the subject is mechaincally ventilated for >28 days.
Measured: Through the initiation of enrollment to 28 days, an average of 1 day
Dosage of rescue sedatives
Dosage of rescue sedatives during mechanical ventilation in the ICU
Measured: Through the useage of sedative drugs in the ICU, an average of 3 days
Frequency of rescue sedatives
Frequency of rescue sedatives during mechanical ventilation in the ICU
Measured: Through the useage of sedative drugs in the ICU, an average of 3 days
Delirium incidence
Delirium incidence during the patients' ICU stay, assessed using ConfusionAssessmentMethodfortheIntensive CareUnit(CAM-ICU, 4 items), delirium is diagnosed when 3 items are met
Measured: Through the ICU stay, an average of 3 days
post-sedation extubation time
Extubation time(hour) after termination of sedation
Measured: From ICU admission to extubation, an average of 3 days
Re-mechanical ventilation incidence after weaning and extubation
Re-mechanical ventilation incidence after weaning and extubation
Measured: Through the ICU stay, an average of 3 days
Proportion of different oxygen therapies post-extubation
Proportion of different oxygen therapies post-extubation
Measured: Through the ICU stay, an average of 3 days
Pain scores during the first 3 postoperative days
Pain scores during the first 3 postoperative days, assessed using Critical-Care Pain Observation Tool(CPOT,0-8), the higher the score, the more painful the patient feels
Measured: The first 3 days of ICU stay, an average of 3 days
Sleep quality scores on the day of ICU discharge
Sleep quality scores on the day of ICU discharge, assessed using St.Mary'sHospitalSleepQuestionnaire(SMHSQ, 11 to 55), the lower the score, the higher the degree of sleep disorders
Measured: The day transfer out of ICU, an average of 1day
Cognitive assessment scores on postoperative day 60
Cognitive assessment scores on postoperative day 60, assessed using Telephone Interview for Cognitive Status-Modified(TICS-m,0-50), the higher the score, the better the cognitive function
Measured: Day 60 after surgery, an average of 1 day
Sleep quality scores on postoperative day 60
Sleep quality scores on postoperative day 60 assessed using Pittsburgh sleep quality index(PSQI,0-21), the higher the score, the worse the sleep quality
Measured: Day 60 after surgery, an average of 1 day
ICU LOS
ICU length of stay
Measured: The day the patient transfer out of ICU, an average of 1 day
Postoperative hospital LOS
postoperative hospital length of stay
Measured: The day the patient discharge, an average of 1 day
60-day all-cause mortality
60-day all-cause mortality
Measured: Day 60 postoperative, an average of 1 day
60-day non-neurological complications
60-day non-neurological complications
Measured: Day 60 postoperative, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start20 Jan 2025
- Primary completion30 May 2026
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Shijitan Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianxin Zhou, doctor, Study chair, Beijing Shijitan Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575530
- Sponsor's protocol ID
- IIT2024-001-002
- Status last verified
- Jun 2026
- First submitted
- 11 Aug 2024
- Last updated
- 16 Jun 2026
- 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06575530
- Acronym / sponsor ID
- IIT2024-001-002
- Conditions
- Effect of Drug, Adverse Drug Event, Mechanical Ventilation Complication, Critical Illness, Surgery, Sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Beijing Shijitan Hospital, Capital Medical UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 28 Aug 2024 (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 multi-center, prospective, randomized, double-blind, active-controlled, no-inferiority clinical trial conducted across 5 tertiary medical centers in China. The objective of this RCT is to evaluate the sedative efficacy and safety profile of remimazolam besylate compared with dexmedetomidine in patients requiring mechanical ventilation following non-cardiac surgery. The study hypothesized that remimazolam besylate is non-inferior to dexmedetomidine regarding the primary efficacy outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remimazolam besylate group | Experimental | Drug: Remimazolam BesylateUpon ICU admission, remimazolam besylate infusion will initiated for light sedation maintenance at a dose range of 0.1 to1.0mg/Kg/h. The target sedation depth is defined as a RASS score of 0 to -2. The RASS score will evaluated and recorded hourly, and the infusion rate of remimazolam besylate will titrated( increased or decreased) accordingly to maintain the patient within the target sedation range. For multimodal analgesia, remifentanil will co-administered continuously at a dose of 0.1 to 0.5ug/Kg/min to ensure a CPOT score of 2 or less. |
| Dexmedetomidine hydrochloride group | Active comparator | Drug: Dexmedetomidine HydrochlorideUpon ICU admission, dexmedetomidine infusion will initiated for light sedation maintenance at a dose range of 0.2 to0.7ug/Kg/h. The target sedation depth is defined as a RASS score of 0 to -2. The RASS score will evaluated and recorded hourly, and the infusion rate of dexmedetomidine will titrated( increased or decreased) accordingly to maintain the patient within the target sedation range. For multimodal analgesia, remifentanil will co-administered continuously at a dose of 0.1 to 0.5ug/Kg/min to ensure a CPOT score of 2 or less. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged between 18 and 64 years
- Scheduled to undergo elective non-cardiac surgery
- Planned for general anesthesia
- With or without combined regional nerve blockade
- Admitted to the ICU with endotracheal intubation post-surgery
Key exclusion criteria (11 listed)
- Undergoing intracranial surgery, or having a history of severe neurological or spinal cord diseases
- Pre-existing history of schizophrenia, epilepsy, or Parkinson's disease
- Inability to communicate preoperatively due to coma, severe dementia, or language barriers
- Preoperative .cardiac insufficiency or severe cardiac arrhythmias
- Severe hepatic impariment( Child-Pugh class C)
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 Besylatepatients will be sedated with remimazolam via intravenous pump on the day of ICU admission, the dosage will titrate with the depth of sedation evaluated with RASS. If the target sedation depth could not to achieved within the prespecified maximum dose range of remimazolam, a standardized rescue sedation protocol will intiated as follows: an intravenous bolus of propofol at 0.2mg/kg will administered. Sedation depth will evaluated 5 minutes post-injection. The identical dose of propofol bolus will repeated until the desired sedation depth is reached. Continuous propofol infusion will initiated after three consecutive bolus injections of propofol. The continuous propofol infusion rate will titrated within the range of 0.2 to 1.0 mg/kg/h until the satisfactory target sedation depth is established. At the subsequent hourly sedation assessment, continuous propofol infusion will discontinued once the patient successfully maintained a stable RASS score within the 0 to -2 range. | Drug | remimazolam besylate group |
| Dexmedetomidine Hydrochloridepatients will be sedated with dexmedetomidine hydrochloride via intravenous pump on the day of ICU admission, the dosage will titrate with the depth of sedation evaluated with RASS. If the target sedation depth could not to achieved within the prespecified maximum dose range of remimazolam, a standardized rescue sedation protocol will intiated as follows: an intravenous bolus of propofol at 0.2mg/kg will administered. Sedation depth will evaluated 5 minutes post-injection. The identical dose of propofol bolus will repeated until the desired sedation depth is reached. Continuous propofol infusion will initiated after three consecutive bolus injections. The continuous propofol infusion rate will titrated within the range of 0.2 to 1.0 mg/kg/h until the satisfactory target sedation depth is established. At the subsequent hourly sedation assessment, continuous propofol infusion will discontinued once the patient successfully maintained a stable RASS score within the 0 to -2 range. | Drug | Dexmedetomidine hydrochloride group |
Primary outcome
Percentage of time in optimal sedation
Time frame: Through the useage of sedative drugs in the ICU, an average of 3 days
Percentage of time in optimal sedation during sedation in the ICU, sedation depth is assessed using Richmond Agitation Sedation Scale(RASS, -5 to +4), target sedation must has a RASS score -2 to 0.
15 secondary outcomes
Ventilation free days
Time frame: Through the initiation of enrollment to 28 days, an average of 1 day
Dosage of rescue sedatives
Time frame: Through the useage of sedative drugs in the ICU, an average of 3 days
Frequency of rescue sedatives
Time frame: Through the useage of sedative drugs in the ICU, an average of 3 days
Delirium incidence
Time frame: Through the ICU stay, an average of 3 days
post-sedation extubation time
Time frame: From ICU admission to extubation, an average of 3 days
Re-mechanical ventilation incidence after weaning and extubation
Time frame: Through the ICU stay, an average of 3 days
Proportion of different oxygen therapies post-extubation
Time frame: Through the ICU stay, an average of 3 days
Pain scores during the first 3 postoperative days
Time frame: The first 3 days of ICU stay, an average of 3 days
Sleep quality scores on the day of ICU discharge
Time frame: The day transfer out of ICU, an average of 1day
Cognitive assessment scores on postoperative day 60
Time frame: Day 60 after surgery, an average of 1 day
Sleep quality scores on postoperative day 60
Time frame: Day 60 after surgery, an average of 1 day
ICU LOS
Time frame: The day the patient transfer out of ICU, an average of 1 day
Postoperative hospital LOS
Time frame: The day the patient discharge, an average of 1 day
60-day all-cause mortality
Time frame: Day 60 postoperative, an average of 1 day
60-day non-neurological complications
Time frame: Day 60 postoperative, an average of 1 day
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 16 Jun 2026.
- 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.
Jianxin Zhou, doctor study chair
Beijing Shijitan Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam Besylate and Dexmedetomidine Hydrochloride in people with Effect of Drug and Adverse Drug Event, run by Beijing Shijitan Hospital, Capital Medical University 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 7 inclusion and 11 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 16 Jun 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yuefu Wang, doctor (+86 ext. 15301306289, wangyuefu3806@bjsjth.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time in optimal sedation (time frame: Through the useage of sedative drugs in the ICU, an average of 3 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 16 Jun 2026.