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

Phase 2

Recruiting

• Conditions: Critically Ill; Deep Sedation
• Interventions: Drug: Remimazolam Besylate; Drug: Propofol

• Registration Number: NCT05539521
• Lead Sponsor: Wuhan Union Hospital, China

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.

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09-05
• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-14
• Last Update Submitted: 2022-09-23
• Last Update Posted: 2022-09-26
• Primary Completion: 2023-02
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam Besylate	Remimazolam Besylate	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.
Propofol	Propofol	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.

Primary Outcome Measures

Name	Time	Method
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	The percentage of time in the target sedation range without rescue sedation

Secondary Outcome Measures

Name	Time	Method
7-day ventitlator free time	From start of study to 7 days	7-day ventitlator free time
Extubation at day 7	From start of study to 7 days	Extubation at day 7
Length of ICU stay	From start of study to 28 days	Length of ICU stay
28-day mortality	From start of study to 28 days	28-day mortality
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	Adverse events

Trial Locations

Locations (1)

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, China