Sedation Clinical Trial
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.
Status | Recruiting |
Enrollment | 285 |
Est. completion date | December 31, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
China | Southern medical university Nanfang hospital | Guangzhou | Guangdong |
China | Peking University Shenzhen Hospital | Shenzhen | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Nanfang Hospital, Southern Medical University | Peking University Shenzhen Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Extubation time | The time from discontinuation of sedation to withdrawal of tracheal catheter. | From date of using the intervention drugs until the date of extubation, up to 28 days. | |
Secondary | Time to recovery | The time from withdrawal of sedation to recovery. | From date of using the intervention drugs until the date of recovery, up to 28 days. | |
Secondary | Drug onset time | The time from discontinuation of sedation to meeting the sedation score requirements (RASS score < -3). | From date of using the intervention drugs until the date of recovery, up to 28 days. | |
Secondary | Time to reach the required sedation score | The proportion of time spent meeting sedation requirements (RASS score <-3) to total time spent on medication | From date of using the intervention drugs until the date of recovery, up to 28 days. | |
Secondary | Mechanical ventilation time during ICU | Time from insertion to withdrawal of tracheal catheter. | From the time you enter ICU to the time you leave ICU. | |
Secondary | Length of ICU stay and total hospital stay | Time from admission to ICU to leave ICU;The time from admission to discharge. | From hospitalization to discharge. | |
Secondary | Adverse event rate | The proportion of cases with adverse events to the total number of cases for evaluation of adverse events. | From date of using the intervention drugs until the date of leaving hospital. |
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