Clinical trial NCT04790734: Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients
Official title: Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Critical Illness
Keywords: Remimazolam besylate
Propofol
Intensive care unit
Mechanical ventilation
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of remimazolam compared to propofol for sedation in mechanically ventilated ICU patients.

Detailed description: This is a single-center, prospective, randomized, controlled pilot study using remimazolam and propofol for sedation in mechanically ventilated ICU patients. 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 and ≤ 75 years;
* Intubated and mechanically ventilated ≤96 hours before enrollment；
* Expected to require continuous invasive ventilation and sedation ≥24 hours;
* Requirement for light to moderate sedation (a RASS score of -3 to 0).

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;
* Pregnancy or lactation.

Primary outcomes:
measure: The percentage of time in the target sedation range without rescue sedation
timeFrame: From the beginning of using study sedatives until being extubated, being discharged from our ICU, the study drug was stopped for 24 hours by physicians, or 7 days after enrollment, whichever came first
Secondary outcomes:
measure: Length of ICU stay
timeFrame: From start of study to 28 days
measure: 28-day mortality
timeFrame: From start of study to 28 days
measure: 7-day ventitlator free time
timeFrame: From start of study to 7 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study officials:
affiliation: Wuhan Union Hospital, China
name: You Shang, Professor
role: PRINCIPAL_INVESTIGATOR
References: