SedationPhase 4NCT05606315
RemImazolam Besylate for ICU-sedation in Patients With Mechanical Ventilation After Oral and Maxillofacial Surgery
A Phase 4 study testing Remimazolam Besylate, Propofol and Midazolam in people with Sedation and ICU, run by Nanfang Hospital, Southern Medical University at 2 sites in China.
Trial summary
Remimazolam besylate, as a new benzodiazepine drug, showing rapid clearance and moderate distribution of pharmacokinetic changes. The study will further explore the safety and effectiveness of remimazolam besylate n the sedation of mechanically ventilated patients after oral and maxillofacial surgery in the ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedation, ICU, Remimazolam Besylate
- What is being tested?
- Remimazolam Besylate, Propofol and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 2 sitesChina
- Study dates
- 16 Mar 2022to 9 Feb 2025
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old;
- After undergoing oral and maxillofacial surgery, it is expected that a ventilator will be needed to assist with breathing;
- mechanical ventilation patients with expected ICU stay time <72h;
- People who need immediate sedative treatment;
- Obtain informed consent from subject or legal representative;
Who cannot join
- Pregnancy；
- Can not get RASS score from patients;
- Allergy to drugs;
- Proven acute and severe intracranial or spinal nerve disease due to vascular, infection, intracranial dilation, or injury;
- Uncompensated acute circulatory failure at randomization (severe hypotension with MAP<50 mmHg despite adequate fluid resuscitation and vasopressor therapy);
- Severe bradycardia (heart rate <50 beats/min) or degree II-III heart block (unless a pacemaker is installed);
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- A history of long-term use of benzodiazepines or opioids;
- Subjects receiving sedation for indications other than to tolerate ventilators (e.g., epilepsy);
- Continuous sedation is unlikely to be required during mechanical ventilation (e.g. Guillain-Barre syndrome);
- Patients determined by the clinician to be unlikely to be removed from mechanical ventilation, such as diseases/injuries that primarily affect respirator neuromuscular function and conditions that clearly require long-term ventilation support (such as high spinal cord injury);
- Participation in any other interventional study (any study that assigns subjects to different treatment groups and/or performs unconventional diagnostic or monitoring procedures).
Trial locations and contacts
2 sites in 1 country.
China2 sites
Southern medical university Nanfang hospital
Guangzhou, Guangdong, 510515
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
About this study
Official title: RemImazolam Besylate for ICU-sedation in Patients With Mechanical Ventilation After Oral and Maxillofacial Surgery: Multicenter, Randomized, Non-inferiority Clinical Study
Remimazolam besylate, as a new benzodiazepine drug, showing rapid clearance and moderate distribution of pharmacokinetic changes. The study will further explore the safety and effectiveness of remimazolam besylate n the sedation of mechanically ventilated patients after oral and maxillofacial surgery in the ICU.
Read the detailed description
Remimazolam besylate is a new type of ultra-short-acting benzodiazepine, showing rapid clearance and moderate distribution of pharmacokinetic changes. Remimazolam has been widely studied for programmed sedation in endoscopic procedures such as gastroenteroscopy and bronchoscopy. Remimazolam, as a short-acting sedative agent that is not metabolized by liver or kidney, can achieve rapid and reversible sedation and has the potential to shorten the duration of mechanical ventilation.
In the oral and maxillofacial surgical treatment, the use of microvascular free tissue transfer for reconstruction is one of the common operations. In order to avoid mechanical damage to the transplanted reconstructed tissue due to spontaneous movement, patients undergoing major head and neck reconstruction surgery are considered to require postoperative deep sedation for a certain period of time (RASS score required -4/-5 points). Deep sedation may cause hypotension and lead to reduced flap perfusion pressure, increasing the risk of hypoperfusion and flap necrosis, thus requiring close postoperative monitoring in the ICU.
Therefore, there is an urgent need for a sedative drug that can achieve rapid and sufficient sedation, does not inhibit breathing and can reduce the amount of patients or rapid recovery after drug withdrawal without increasing delirium. Based on the deficiencies of currently used sedatives and the potential advantages of remimazolam, we hypothesize that remimazolam can shorten the extubation time and lower the adverse reaction rate in patients with oropharyngeal cancer after mechanical ventilation sedation.
Therefore, we conducted a multicenter, randomized, non-inferiority pilot study to compare the efficacy and safety of remimazolam besylate, propofol, and midazolam in this patient population.
- Conditions
- Sedation, ICU, Remimazolam Besylate
- Keywords
- Remimazolam besylate, Oral cancer, Sedation, ICU
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam BesylateDrug
NS 50ML + Remimazolam besylate(50mg , 2mg:2ml), IV-Pump,maintenance dose 0.5-3mg/kg/h.
PropofolDrug
Propofol (50ml, 0.5g), IV-Pump, maintenance dose 0.3-4.0mg/kg/h.
MidazolamDrug
Midazolam (10mg,2ml), IV-Pump, maintenance dose 0.02-0.1mg/kg/h.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam besylate | Experimental | Remimazolam besylate is a new ultra-short-acting benzodiazepine drug, which is a benzodiazepine central nervous system inhibitor. It can bind to central GABAA receptors and produce sedative effects in animal experiments. Currently, it is used in painless diagnosis and treatment sedation, colonoscopy sedation, general anesthesia, ICU sedation and local anesthesia sedation. Receives: Drug: Remimazolam Besylate |
| propofol | Active comparator | Propofol, known chemically as 2, 6-diisopropyl phenol, is an organic compound with the chemical formula C12H18O and is a short-acting intravenous anesthetic used for the induction and maintenance of general anesthesia. It is often used in conjunction with epidural or spinal anesthesia, as well as with analgesics, muscle relaxants, and inhalation anesthetics. Receives: Drug: Propofol |
| midazolam | Active comparator | Midazolam, an organic compound with the chemical formula C18H13ClFN3, is used clinically to treat insomnia and can also be used to induce sleep during surgery or diagnostic tests. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation time
The time from discontinuation of sedation to withdrawal of tracheal catheter.
Measured: From date of using the intervention drugs until the date of extubation, up to 28 days.
Secondary outcomes (6)
Time to recovery
The time from withdrawal of sedation to recovery.
Measured: From date of using the intervention drugs until the date of recovery, up to 28 days.
Drug onset time
The time from discontinuation of sedation to meeting the sedation score requirements (RASS score < -3).
Measured: From date of using the intervention drugs until the date of recovery, up to 28 days.
Time to reach the required sedation score
The proportion of time spent meeting sedation requirements (RASS score <-3) to total time spent on medication
Measured: From date of using the intervention drugs until the date of recovery, up to 28 days.
Mechanical ventilation time during ICU
Time from insertion to withdrawal of tracheal catheter.
Measured: From the time you enter ICU to the time you leave ICU.
Length of ICU stay and total hospital stay
Time from admission to ICU to leave ICU;The time from admission to discharge.
Measured: From hospitalization to discharge.
Adverse event rate
The proportion of cases with adverse events to the total number of cases for evaluation of adverse events.
Measured: From date of using the intervention drugs until the date of leaving hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start16 Mar 2022
- Primary completion12 Jan 2025
- Study completion9 Feb 2025
Why it stopped: The trial was terminated early because additional sites did not recruit as planned, making the multicenter sample size infeasible. Enrollment ended after 117 participants were randomized at Nanfang Hospital, unrelated to safety, efficacy, or outcomes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Shenzhen Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606315
- Sponsor's protocol ID
- NFEC-2021-341
- Status last verified
- Jun 2026
- First submitted
- 2 Nov 2022
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RemImazolam Besylate for ICU-sedation in Patients With Mechanical Ventilation After Oral and Maxillofacial Surgery: Multicenter, Randomized, Non-inferiority Clinical Study
- ClinicalTrials.gov ID
- NCT05606315
- Acronym / sponsor ID
- NFEC-2021-341
- Conditions
- Sedation, ICU, Remimazolam Besylate
- Keywords
- Remimazolam besylate, Oral cancer, Sedation, ICU
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated early because additional sites did not recruit as planned, making the multicenter sample size infeasible. Enrollment ended after 117 participants were randomized at Nanfang Hospital, unrelated to safety, efficacy, or outcomes
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Peking University Shenzhen Hospital
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 12 Jan 2025 (actual)
- Study completion
- 9 Feb 2025 (actual)
- First posted
- 4 Nov 2022 (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.
Remimazolam besylate, as a new benzodiazepine drug, showing rapid clearance and moderate distribution of pharmacokinetic changes. The study will further explore the safety and effectiveness of remimazolam besylate n the sedation of mechanically ventilated patients after oral and maxillofacial surgery in the ICU.
Detailed description
Remimazolam besylate is a new type of ultra-short-acting benzodiazepine, showing rapid clearance and moderate distribution of pharmacokinetic changes. Remimazolam has been widely studied for programmed sedation in endoscopic procedures such as gastroenteroscopy and bronchoscopy. Remimazolam, as a short-acting sedative agent that is not metabolized by liver or kidney, can achieve rapid and reversible sedation and has the potential to shorten the duration of mechanical ventilation.
In the oral and maxillofacial surgical treatment, the use of microvascular free tissue transfer for reconstruction is one of the common operations. In order to avoid mechanical damage to the transplanted reconstructed tissue due to spontaneous movement, patients undergoing major head and neck reconstruction surgery are considered to require postoperative deep sedation for a certain period of time (RASS score required -4/-5 points). Deep sedation may cause hypotension and lead to reduced flap perfusion pressure, increasing the risk of hypoperfusion and flap necrosis, thus requiring close postoperative monitoring in the ICU.
Therefore, there is an urgent need for a sedative drug that can achieve rapid and sufficient sedation, does not inhibit breathing and can reduce the amount of patients or rapid recovery after drug withdrawal without increasing delirium. Based on the deficiencies of currently used sedatives and the potential advantages of remimazolam, we hypothesize that remimazolam can shorten the extubation time and lower the adverse reaction rate in patients with oropharyngeal cancer after mechanical ventilation sedation.
Therefore, we conducted a multicenter, randomized, non-inferiority pilot study to compare the efficacy and safety of remimazolam besylate, propofol, and midazolam in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remimazolam besylate | Experimental | Drug: Remimazolam BesylateRemimazolam besylate is a new ultra-short-acting benzodiazepine drug, which is a benzodiazepine central nervous system inhibitor. It can bind to central GABAA receptors and produce sedative effects in animal experiments. Currently, it is used in painless diagnosis and treatment sedation, colonoscopy sedation, general anesthesia, ICU sedation and local anesthesia sedation. |
| propofol | Active comparator | Drug: PropofolPropofol, known chemically as 2, 6-diisopropyl phenol, is an organic compound with the chemical formula C12H18O and is a short-acting intravenous anesthetic used for the induction and maintenance of general anesthesia. It is often used in conjunction with epidural or spinal anesthesia, as well as with analgesics, muscle relaxants, and inhalation anesthetics. |
| midazolam | Active comparator | Drug: MidazolamMidazolam, an organic compound with the chemical formula C18H13ClFN3, is used clinically to treat insomnia and can also be used to induce sleep during surgery or diagnostic tests. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years old;
- After undergoing oral and maxillofacial surgery, it is expected that a ventilator will be needed to assist with breathing;
- mechanical ventilation patients with expected ICU stay time <72h;
- People who need immediate sedative treatment;
- Obtain informed consent from subject or legal representative;
Key exclusion criteria (11 listed)
- Pregnancy；
- Can not get RASS score from patients;
- Allergy to drugs;
- Proven acute and severe intracranial or spinal nerve disease due to vascular, infection, intracranial dilation, or injury;
- Uncompensated acute circulatory failure at randomization (severe hypotension with MAP<50 mmHg despite adequate fluid resuscitation and vasopressor therapy);
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 BesylateNS 50ML + Remimazolam besylate(50mg , 2mg:2ml), IV-Pump,maintenance dose 0.5-3mg/kg/h. | Drug | Remimazolam besylate |
| PropofolPropofol (50ml, 0.5g), IV-Pump, maintenance dose 0.3-4.0mg/kg/h. | Drug | propofol |
| MidazolamMidazolam (10mg,2ml), IV-Pump, maintenance dose 0.02-0.1mg/kg/h. | Drug | midazolam |
Primary outcome
Extubation time
Time frame: From date of using the intervention drugs until the date of extubation, up to 28 days.
The time from discontinuation of sedation to withdrawal of tracheal catheter.
6 secondary outcomes
Time to recovery
Time frame: From date of using the intervention drugs until the date of recovery, up to 28 days.
Drug onset time
Time frame: From date of using the intervention drugs until the date of recovery, up to 28 days.
Time to reach the required sedation score
Time frame: From date of using the intervention drugs until the date of recovery, up to 28 days.
Mechanical ventilation time during ICU
Time frame: From the time you enter ICU to the time you leave ICU.
Length of ICU stay and total hospital stay
Time frame: From hospitalization to discharge.
Adverse event rate
Time frame: From date of using the intervention drugs until the date of leaving hospital.
Results and safety
The study was stopped early (reason given: The trial was terminated early because additional sites did not recruit as planned, making the multicenter sample size infeasible. Enrollment ended after 117 participants were randomized at Nanfang Hospital, unrelated to safety, efficacy, or outcomes). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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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.
2 sites 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, Propofol and Midazolam in people with Sedation and ICU, run by Nanfang Hospital, Southern Medical University at 2 sites 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 5 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: stopped early, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: The trial was terminated early because additional sites did not recruit as planned, making the multicenter sample size infeasible. Enrollment ended after 117 participants were randomized at Nanfang Hospital, unrelated to safety, efficacy, or outcomes). Results are not available in the source record.
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?
Extubation time (time frame: From date of using the intervention drugs until the date of extubation, 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 2 Jul 2026.