Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Critically Ill Patients With Deep Sedation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of remimazolam besylate compared to propofol for sedation in critically ill patients with deep sedation.

Detailed Description
-----------------
This is a single-center, prospective, randomized, controlled study using remimazolam besylate and propofol for sedation in critically ill patients with deep sedation. Subjects are randomized to remimazolam group and propofol group in a 1:1 ratio. Remifentanil is administered as the analgesic. Efficacy and safety profiles of remimazolam besylate are to be evaluated.

Official Title
-----------------
Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Critically Ill Patients With Deep Sedation

Conditions
-----------------
Critically Ill, Deep Sedation

Intervention / Treatment
-----------------
* Drug: Remimazolam Besylate
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 and ≤ 80 years; Expected to require deep sedation ≥8 hours; Requirement for deep sedation (a Narcotrend index between 13 and 64). Exclusion Criteria: Body mass index (BMI) <18 or >30 kg/m2; Acute severe neurological disorder and any other condition interfering with RASS assessment; Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors; Heart rate less than 50 beats/min; Second- or third-degree heart block in the absence of a pacemaker; Unstable angina; Acute myocardial infarction; Left ventricular ejection fraction less than 30%; Contraindicate or allergic to study drugs; Moribund state; Acute hepatitis or serious hepatic dysfunction (Child-Pugh class C); Chronic kidney disease with glomerular filtration rate (GFR) < 60 ml/min/1.73m2; Alcohol abuse; Myasthenia gravis; Expected to have a general anesthesia within 8 hours; Pregnancy or lactation.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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>Patients in the remimazolam group received remimazolam besylate at an initial infusion rate of 0.3 mg/kg/h and adjusted to maintain a Narcotrend index between 13 and 64. | Drug: Remimazolam Besylate<br>* sedation drugs<br>|
| Active Comparator: Propofol<br>Patients in the propofol group received propofol at an initial infusion rate of 3.0 mg/kg/h and adjusted to maintain a Narcotrend index between 13 and 64. | Drug: Propofol<br>* Propofol<br>|

What is the study measuring?
-----------------
Primary 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 | From the beginning of using study sedatives until being discharged from our ICU, the sedation target was changed, 48 hours after enrollment, or dead, whichever came first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Adverse events | From the beginning of using study sedatives until being discharged from our ICU, the sedation target was changed, 48 hours after enrollment, or dead, whichever came first | 
| 7-day ventitlator free time | 7-day ventitlator free time | From start of study to 7 days | 
| Extubation at day 7 | Extubation at day 7 | From start of study to 7 days | 
| Length of ICU stay | Length of ICU stay | From start of study to 28 days | 
| 28-day mortality | 28-day mortality | From start of study to 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Remimazolam besylate, Propofol, Intensive care unit, Deep sedation