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New sedative could speed recovery for ventilator patients

NCT ID NCT05606315

Symptom relief Sponsor: Nanfang Hospital, Southern Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tests a new sedative called remimazolam for people in the ICU who need a breathing tube after oral or facial surgery. It compares remimazolam to two standard sedatives, propofol and midazolam, to see if it works just as well and helps patients wake up faster. The trial involves 117 adults and is currently on hold.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Remimazolam besylate
What this could lead to
If it works, this could offer a safer, faster-recovery sedation option for ICU patients after oral surgery.
What could go wrong
This is a small pilot trial that is currently suspended, so results are uncertain. It only tests short-term sedation, not long-term outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

117 people

The number who actually took part.

Started

Mar 2022

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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; Exclusion Criteria: * 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); * 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).

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Conditions

The condition(s) this trial relates to.

Mouth Neoplasms oropharyngeal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ICU Remimazolam besylate Sedation

Contacts and locations

Locations

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036, China

  • Southern medical university Nanfang hospital

    Guangzhou, Guangdong, 510515, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.