Clinical trial · Interventional
RemImazolam Besylate for ICU-sedation in Patients With Mechanical Ventilation After Oral and Maxillofacial Surgery
RemImazolam Besylate for ICU-sedation in Patients With Mechanical Ventilation After Oral and Maxillofacial Surgery: Multicenter, Randomized, Non-inferiority Clinical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ICU | — | UNRESOLVED | — |
| Remimazolam Besylate | — | UNRESOLVED | — |
| Sedation | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Midazolam | Drug | — | UNRESOLVED |
| Propofol | Drug | — | UNRESOLVED |
| Remimazolam Besylate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Remimazolam besylate
- description
- 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.
- interventionNames
- Drug: Remimazolam Besylate
- type
- ACTIVE_COMPARATOR
- label
- propofol
- description
- 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.
- interventionNames
- Drug: Propofol
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available