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

Critically Ill Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05539521
• Other study ID #: WUHICU202202
• Status: Recruiting
• Phase: Phase 2
• Start date: September 5, 2022
• Est. completion date: March 2023

Study information

• Verified date: September 2022
• Source: Wuhan Union Hospital, China
• Contact: Xiaobo Yang, MD
• Phone: +8602785351606
• Email: want.tofly[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Deep Sedation

Intervention

Drug:
• Remimazolam Besylate
sedation drugs
• Propofol
Propofol

Locations

Country	Name	City	State
China	Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	7-day ventitlator free time	7-day ventitlator free time	From start of study to 7 days
Secondary	Extubation at day 7	Extubation at day 7	From start of study to 7 days
Secondary	Length of ICU stay	Length of ICU stay	From start of study to 28 days
Secondary	28-day mortality	28-day mortality	From start of study to 28 days