Clinical trial NCT05539521: Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Critically Ill Patients With Deep Sedation
Official title: Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Critically Ill Patients With Deep Sedation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Critically Ill
Deep Sedation
Keywords: Remimazolam besylate
Propofol
Intensive care unit
Deep sedation
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 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.

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.

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 discharged from our ICU, the sedation target was changed, 48 hours after enrollment, or dead, whichever came first
Secondary outcomes:
measure: Adverse events
timeFrame: 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
measure: 7-day ventitlator free time
timeFrame: From start of study to 7 days
measure: Extubation at day 7
timeFrame: From start of study to 7 days
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
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: