Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients

Critical Illness Clinical Trial

Official title:

Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04790734
• Other study ID #: WUHICU202101
• Status: Completed
• Phase: Phase 2
• Start date: May 10, 2021
• Est. completion date: May 12, 2022

Study information

• Verified date: September 2022
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 12, 2022
• Est. primary completion date: April 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness

Intervention

Drug:
• Sedation drugs
Different sedation drugs

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 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	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
Secondary	7-day ventitlator free time	7-day ventitlator free time	From start of study to 7 days