Short-term Sedation With Remimazolam Besylate in Patients Receiving Invasive Mechanical Ventilation

Study Overview
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Brief Summary
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A randomized non-inferior trial comparing remimazolam besylate with propofol for short-term sedation during invasive mechanical ventilation in intensive care units

Official Title
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Short-term Sedation With Remimazolam Besylate Versus Propofol in Patients Receiving Invasive Mechanical Ventilation in Intensive Care Units: a Multi-center Randomized Non-inferior Trial

Conditions
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Sedative, Mechanical Ventilation

Intervention / Treatment
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* Drug: Remimazolam besylate
* Drug: Propofol
* Drug: Remifentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 and ≤ 80 years Body mass index (BMI) ≥18 and ≤ 30 kg/m2 Being Intubated and mechanically ventilated ≤48 hours before enrollment and expected to be on ventilator for at least 6 hours Requirement for light to moderate sedation (a Richmond agitation-sedation scale score of -2 to 1) Exclusion Criteria: Refusal to be included Allergy or unsuitability to any composition of study drugs or remifentanil Living expectancy less than 48 hours Myasthenia gravis Status asthmaticus Abdominal compartment syndrome Serious hepatic dysfunction (CTP 10-15); Chronic kidney disease with glomerular filtration rate (GFR) < 29 ml/min/1.73m2 Mean blood pressure less than 65 mm Hg or the need of a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain Mean blood pressure ≥ 65 mm Hg Possible requirement for surgery or bedside tracheostomy in 24 hours Possible requirement for renal replacement therapy in 24 hours Acute severe neurological disorder and any other condition interfering with sedation assessment Abuse of controlled substances or alcohol Pregnancy or lactation Inclusion in another interventional trial in the past 30 days Other conditions deemed unsuitable to be included

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam besylate<br>Remimazolam besylate | Drug: Remimazolam besylate<br>* 0 2.0mg/kg/h<br>Drug: Remifentanil<br>* 1.5 12μg/kg/h<br>|
| Active Comparator: Propofol<br>Propofol | Drug: Propofol<br>* 0.3 4.0mg/kg/h<br>Drug: Remifentanil<br>* 1.5 12μg/kg/h<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful sedation | 70% of time in the target sedation range in participants without rescue sedation | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of time in the target sedation range without rescue sedation | The percentage of time in the target sedation range without rescue sedation | 24 hours | 
| Number of patients needing rescue sedation | Whether participants need sedative drugs other than the study drug to re maintain targeted sedation level | 24 hours | 
| Number of patients needing repeated boluses of the study drug | Whether participants need repeated boluses of the study durg other than the loading dose to maintain targeted sedation level | 24 hours | 
| The amount of remifentanil in ug/kg/h | The amount of remifentanil in ug/kg/h used in each patient in both groups | 24 hours |